Q4 2024 Nanobiotix SA Earnings Call

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Unknown Attendee: Good day and welcome to the Nanobiotics Business Update and Full Year 2024 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.

Speaker Change: Good day and welcome to the <unk>, none of the Baltics business update and full year 'twenty 'twenty four financial results conference call.

Speaker Change: At this time all participants are in a listen only mode.

Speaker Change: After the speaker's presentation, there will be a question and answer session. Please be advised that today's conference is being recorded.

Unknown Attendee: Please be advised that today's conference is being recorded.

Craig West: At this point I would turn the call over to Craig West, Senior Vice President of Investor Relations of Nanobiotix. Please go ahead. Thank you.

Speaker Change: At this point I would turn the call over to Great West Senior Vice President of Investor Relations of no politics. Please go ahead.

Craig West: 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 Rijn, Chief Financial and Business Officer. As a reminder, today's call is being webcast and will be available on our website for replay.

Speaker Change: Thank you good afternoon, and good morning, and welcome to the Nano Biotics conference call to discuss our full year 2024 financial and operational results joining.

Speaker Change: Joining me on the call today are Laurent Levy co founder and Chief Executive Officer, and Bart Van Ryan Chief Financial and business Officer.

Speaker Change: As a reminder, today's call is being webcast and will be available on our web site for replay.

Craig West: 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 others. 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.

Speaker Change: 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.

Speaker Change: A presentation and future research and development efforts amongst other things.

Speaker Change: 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 occur.

Speaker Change: Accordingly, you are cautioned not to place undue reliance on forward looking statements.

Craig West: 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, Nanobiotix undertakes no obligation to update them to reflect subsequent events or for future circumstances.

Speaker Change: He used to review the full description of risk factors can be found in the documents, we filed with the a M F in France and the FCC 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.

Speaker Change: 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 antibiotics undertakes no obligation to update them to reflect subsequent events.

Speaker Change: Orford future circumstances with that said I'd like to turn the call over to the wrong. Please go ahead.

Laurent Levy: With that said, I'd like to 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 NBTXR3 or JNJ1900. And also, we'll give you some financial highlights and operational highlights for 2024 and 2025.

Speaker Change: Thank you Craig and welcome everyone.

Speaker Change: Today, we're going to talk about the progress we've been making with N b checks out tree or J&J 19, underwrite and also it will give you some financial highlights and operational highlights for <unk> 24, and 25, and we will hand this call with a Q&A session.

Laurent Levy: And we will end this call with a Q&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 Change. In 23, we've been signing this $2.6 bio deal plus royalties with J&J and now pushing into different direction and different indication. If you think about just the two first indication in lung cancer and head and neck cancer, those two first only could represent over 100,000 patients addressable in the U.S. and EU5 alone, which could lead to a potential $10 billion market. As you will see, we have many things ongoing and this collaboration is progressing well.

Speaker Change: We have made very good progress toward our pathway to sustainability and growth and starting by continuing pushing in developing this collaboration with J&J.

Speaker Change: In 23, we've been signing these two six a buyout of our deals plus royalties with J&J and no pushing into a different direction and defense indication if.

Speaker Change: If you think about just the two first indication in lung cancer and head and neck cancer. Those two first only could represent over 100000 patients addressable in the U S and EU feigenbaum, which could lead to a potential 10 billion market.

Speaker Change: As you will see we have many things ongoing in this collaboration is progressing well, but he's not the only thing that would lead us to sustainability. There is also the new platform. We are developing and this year, we've been launching a new platform first in class product with <unk>.

Laurent Levy: But it's not the only thing that will lead us to sustainability. There is also the new platform we are developing. And this year, we've been launching our new platform, First-in-Class Product with Curadigm. We'll talk about that a bit later.

Laurent Levy: But first, let's move to the next slide and see how do we plan to address one of the largest untapped markets in oncology. Slide six, you can see our pipeline. And as you will remember, MBTXR3, 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 indication in oncology, as you can see in our pipeline. So we've been progressing a lot this pipeline this year in different indication, including two very important ones. The Nanowire 312, which concerns elderly patients in head and neck that are frail and ineligible to cisplatin, but also the Lung Stage 3 program that J&J started this year.

Speaker Change: We'll talk about that a bit later, but first let's move to next slide and see.

Speaker Change: How do we tend to address one of the largest untapped markets you know oncology.

Speaker Change: Slide six you can see our pipeline and as you will remember <unk> XR tree, our product is a product that is very versatile.

Speaker Change: That is tomorrow agnostic patient agnostic and target agnostic, which means that we could literally combine that in many indication in oncology as you can see in our pipeline. So we've been progressing a lot. This pipeline this year in different indication, including two very important one.

Speaker Change: The amount of <unk>, 12, which concerned elderly patients in head and neck that Australia and energy bills to cisplatin, but also the lung stage III program that Jim just started this year.

Laurent Levy: Let's move to the key development we've been doing, starting with Nanorate 312. 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 24 is first aligning on the transfer to change of this program. And we did that midstream of the development of the Nano Ray 321. 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 J&J to be ready, assuming the data are positive, to push the return and start registration of the product.

Jim: Let's move to the key development, we've been doing starting with none or a tweet 12. This is a payable to all phase III study in locally advanced head and neck cancer. It is a global study 500 patients randomized one to one.

Jim: What we've been doing in 'twenty four is first aligning on the transfer to J&J of this program and we did that midstream of the development of the <unk>.

Jim: Why we did it because we felt it was the best thing possible to do with this study.

Jim: Rather than waiting the final data before transferring which would have caused some delay both thresholds. We said that it will be much better to do it now.

Jim: Therefore, a change yet to be ready assuming the data are positive to push the return it and Scott registration of the product.

Laurent Levy: We expect to complete this transfer around Q3 of this year.

Jim: We expect to complete this transfer.

Laurent Levy: So that's for the NanoRay 312, which is progressing and now being transferred to J&J. On the other side, J&J has started a new trial named CONVERGE. It is a randomized phase two study in an unrespectable stage three lung cancer. And the first patient have been dosed in January this year. And this trial progressed quite well.

Jim: Q3 of this year. So that's further none or a tweet 12, which is progressing and now being transferred to J&J on the other side.

Jim: Jay I started a new trial named comes out it is a randomized phase II study in Unresectable stage III lung cancer and the first patient has been dosed in January this year and this trial progressed quite well.

Laurent Levy: Moving to next slide. Those are not the two only development or clinical development that have progressed. We also have early stage study that are progressing across solid tumor. Let's start with head and neck recurrent and recurrent metastatic cancer patients that are eligible to PD-1. So of phase 1 study 1100, I've 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-1, but also the refractory PD-1 on the completion of these two cohorts.

Jim: Moving to next slide.

Jim: Do not be to only <unk>.

Jim: Development of our clinical development that have progressed. We also have early stage study that are progressing across solid tomorrow.

Jim: Let's start with Nick recurrent and recognize that cancer patients that are eligible to PD. One so a phase one study 11 Andrade had been showing last year, so I'm positive data.

Jim: 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 patient at all first line PD, one, but also the refractory to PD one on the completion of these two cohorts.

Laurent Levy: 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 respectable. We've been completing the first 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 a good result for the first one, we decided with MDA to expand into a new cohort, which this time will be the same treatment within the standard of care, meaning radiation plus chemo plus nano particle for pancreatic locally advanced cancer patients.

Jim: We've been also progressing in pancreatic cancer. That's one of the trial, we are doing with MD Anderson cancer Center. It is about patients that are locally advanced all borderline resectable, we've been completing the phase one and got some meridian encouraging outcome in terms of safety profile of the <unk>.

Jim: But also in terms of efficacy and has we've seen such a good result for the phase one we decided with NDA to expanding to a new cohort, which this time will be the same treatment within the standoff cure, meaning radiation plus chemo plus nano particle for pancreatic <unk> Luckily it.

Jim: Advanced cancer patients.

Laurent Levy: This second cohort has started and recruiting well.

Jim: This second cohort are started and recruiting well.

Laurent Levy: We should expect also this year to get a result from the escalation part and the expansion part of the trial before the summer.

Jim: We should expect also this year to get a result from the escalation part in the expansion part of the trial.

Laurent Levy: In lung cancer, we recently published some data coming also from Andy Anderson Cancer Center. They have completed the dose escalation part of a phase one in no 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.

Jim: Before the summer.

Jim: In lung cancer, we recently published some data coming also from Amgen a sudden cancer center. They have completed the dose escalation part of phase one in non small cell lung cancer that already received some previous treatment and are eligible for re irradiation.

Jim: Did it out were really good in terms of safety and feasibility against very consistent versus all of our trials, we've been showing and we start to see either an early some very interesting sign ups of efficacy, meaning local control of the tumor which is essential for those patients.

Laurent Levy: So as you can see, we have been progressing the pipeline and will continue as we expect many more clinical data coming this year.

Jim: So as you can see we have been progressing the pipeline and we'll continue as we expect many more clinical data coming this year.

Laurent Levy: In parallel to NBTXR3 or JNJ1900, we've been launched a paradigm of fully owned next generation nanotherapeutic platform. This is based on nanoparticles and nanophysics. And again, something that we expect to be useful for many, many patients, millions of patients, but not only for one indication or one therapeutic area. It is something that we expect to be used in many therapeutic areas in combination with many types 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.

Jim: In parallel to <unk> XR tree, all J&J 19, Andre we've been launch right I'm fully on next generation nano therapeutics platform.

Jim: This is based on nanoparticle and nano physics and again.

Jim: Something that we expect to be useful for many many patients millions of patients, but don't tell me 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 product. So as you may remember those are nanoparticle that are design to <unk>.

Barry: Barry occupied.

Jim: <unk>.

Jim: And why deliveries BZ, we reduced particle when you inject something else in the patients then deliver accumulation will be decreased and to a certain extent will completely change the bioavailability of the second product that you inject so.

Laurent Levy: 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 partnership. And that's a strong activity we are leading this year, talking to biotech and pharma industry.

Jim: This has a strong potential to increase the efficacy or decreased toxicity of existing products.

Jim: 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.

Jim: 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 partnership and thats. The strong activity. We are leading this year took into biotech and pharma industry.

Laurent Levy: On the top of progressing our collaboration and platform development, we also have added two new board observers to the Nanobiotix 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.

Jim: On the top of progressing our collaboration and platform development. We also have added two new Board observer.

Jim: <unk> nano biopsies board, Margaret and Anna and we'd like to welcome them for their contribution also they already have.

Jim: Brought to the company and a CTO contribution we intend to confirm the subserve her and make them full member at the next General Assembly.

Bart Van Rijn: 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. Thank you, Laurent. Good morning and good afternoon, everyone. Moving to the next slide. As Laurent mentioned earlier, Nanobiotix 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 & 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 million payments related to NanoRay 312 progress.

Jim: That's it for this party and I'm not going to give the mic to Bob to give you some operational and financial highlights.

Bob: Thank you Laura good morning, and good afternoon, everyone.

Speaker Change: Moving to the next slide as Luann mentioned earlier, none will be Alex 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.

Speaker Change: Went to our progress in 2023, and which we signed the license agreement with Johnson <unk> Johnson and completed the follow on offering.

Speaker Change: Recent activities include the receipt of the first milestone payment in May 2024, when we received a $20 million payments related to <unk> 312 progress.

Bart Van Rijn: Continuing this execution, we announced last month the signing of an amendment to the Global Licensing Agreement for MBTXR3. This amendment has several important provisions. including removing the vast majority of the Nanobiotix funding obligation for Nanoray 312, releasing J&J from select future potential milestone payments, and safeguarding Nanobiotix' path to sustainable cash flow through hundreds of millions in potential milestone payments related to LEAP programs expected in the coming years. As a result of these changes to the license agreement, we have extended our cash runway to mid-2026 and not to be missed, these changes should result in a meaningful reduction in cash burn beyond mid-2026, as the full cost of a Phase III study will no longer be reflected in our financials.

Speaker Change: And continuing this execution, we announced last month, the signing of an amendment to the global licensing agreement for <unk> XR three.

Speaker Change: This amendment has several important provisions including <unk>.

Speaker Change: Removing the vast majority of the mental biotics funding obligation for <unk> hundred 12, releasing J&J from select future potential milestone payments.

Speaker Change: And safe guarding than a build a path to sustainable cash flow through hundreds of millions in potential milestone payments related to lead programs expected in the coming years.

Speaker Change: As a result of these changes to the license agreement, we have extended our cash runway to mid 2026 and not to be missed these changes should result in a meaningful reduction in cash burn beyond mid 2026 as the full cost of the phase III study will no longer be reflected in our financials.

Bart Van Rijn: And we're not done. We are continuing to actively explore further financing options, preferably non-dilutive, to extend cash feasibility into 2027. This is rooted in the belief that our first platform provides a path for Nanobiotix 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.

Speaker Change: And we're not done we are continuing to actively explore further financing options refurbishing more dilutive to extend cash visibility into 2027.

Speaker Change: This is rooted in the belief that our first platform provides a path for <unk> to reach financial stability in the next few years.

Speaker Change: As we advance to the next slides we show here the elements of the amended agreement overtime.

Speaker Change: We can share with you what has transpired so far as well as our outlook should data readouts and regulatory approvals come in positive there.

Speaker Change: The left column represents element of agreements that occur already or are ongoing. This includes the $80 million already received made up of the upfront equity in the first milestone I mentioned previously there are many elements of the agreement on <unk> suggests that transfer product supply.

Bart Van Rijn: This includes the $18 million 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&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's 200 million 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&J. When we look at the right-hand side of the slide, we can see that we maintain the royalties, we maintain the 220 million per new indication developed by Nanobiotix, which would require funding by Nanobiotix, as well as more than 2.3 billion relating to long-term milestones of the ongoing program.

Speaker Change: J&J investing and duplication of our manufacturing capabilities and starting the randomized cohort study in non small cell lung cancer.

Speaker Change: In the Middle you can see that there is 200 million plus of medium term milestones that we expect in the next two to three years.

Speaker Change: Lead to a sustainably finance company increased commitments from J&J.

Speaker Change: When we look at the right hand side of the slides, we can see that we maintain the royalties we maintained the $220 million per new indication developed by an antibiotic.

Speaker Change: Which would require funding by <unk> as well as more than $2 3 billion relating to long term milestones will be ongoing programs.

Bart Van Rijn: development and regulatory milestones of potential additional indications, sales milestones that are indication agnostic, as well as the lead 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&J regarding the operational success of NanoWave 312 as reflected in the amendment.

Speaker Change: Development and regulatory milestones of potential additional indications sales milestones that are indications gnostic as well as to leave biomass stones.

Speaker Change: Our greater China region.

Speaker Change: Describe this more in a moment.

Speaker Change: The settlement of these items allows nando to focus on supporting J&J regarding the operational success of <unk> hundred 12 is reflected in the amendments.

Bart Van Rijn: 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 million in total has been removed from the first and third bucket from a milestone perspective. The first bucket now reaches up to 1.77 billion, and the third bucket, which was the Liam Bio bucket, now Jensen bucket, which is up to 165 million versus 205 million prior, related to the greater China region. In total, the agreement and rights assignment represent a potential of 2.6 billion in milestones, with potential for additional royalties from the low teens to low 20s as percent of sales.

Speaker Change: S returned to the next slide I wanted to share a recap of the overall structure post the amendments we've presented this before and these are post amendment numbers as I already indicated royalties have not changed.

Speaker Change: One of the $5 million in total has been removed from the first and third buckets from a milestone perspective.

Speaker Change: The first bucket now reaches up to $1 77 billion in the third bucket, which was the bio buckets now Jensen bucket, which is up to $65 million versus 205 million prior.

Related to the greater China region.

Speaker Change: In total the agreement and Reits assignment represent potential of $2 6 billion and milestones with potential for additional milestone from indications, we may develop and funds and will receive tiered royalties from the low teens to low twenties as percent of sales.

Bart Van Rijn: Now let's turn our attention to the full year 2024 financial highlights on the next slide. Negative revenue of $7.2 million was recognized in 2024 compared to $36.2 million for the year ended December 31, 2023. Significant revenue was recorded in 2023 in connection with the execution of the license agreement with Jensen. as well as the recognition of the NANO-A312 development model. The negative revenue impact recognized in 2024 results from the transfer of NanoAid 312 study sponsorship to Jensen, signed at the end of 2024, which amounts to negative 19.3 million euro revenue impact. which is driven by a one-time recognition of a net liability towards Janssen to affect this new situation.

Speaker Change: Now, let's turn our attention to the full year 2024 financial highlights on the next slides.

Speaker Change: Negative revenue of $7 2 million was recognized in 2024 compared to $36 2 million for the year ended December 31 2023.

Speaker Change: Significant revenue was recorded in 2023 in connection with the execution of the license agreement with Janssen.

Speaker Change: As well as the recognition of the mineral way 312 development milestone the negative revenue impact recognized in 2024 results from the transfer of <unk> Hundred 12 study sponsorship to Johnson science at the end of 2024, which amounts to negative $19 3 million Euro revenue impact.

Speaker Change: Which is driven by a onetime recognition of a net liability towards janssen to affect this new situation.

Bart Van Rijn: This net liability is made up of the refund obligation the company has towards Jensen regarding the NanoWave 312 total remaining costs that will remain with the company, which is offset by residual contract liability and R&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 non-cash 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 €5.9 million, technology transfer services billed to Jensen for €1.8 million, and research tax credits for €3.3 million.

Speaker Change: There's net liability is made up of the refund obligation to company has towards Jameson regarding <unk> hundred 12 total remaining costs that will remain with the company, which is offset by a residual contract liability.

Speaker Change: R&D services recognized in 2024.

Speaker Change: These net liability was recognized at the time of the execution of the amendment and as a result of the application of <unk> 15 revenue recognition accounting treatment, which generates accumulative negative catch up.

Speaker Change: To be clear this negative revenue amount is a non cash item and therefore does not impact <unk> cash position.

Speaker Change: This one off negative impact is partially offset by all the revenues recognized in 2024, the Conversely, do positively impact our cash position, including sales of clinical products.

Speaker Change: And the suppliers.

Speaker Change: $5 9 million Euro technology transfer services built to Janssen for $1 8 million.

Speaker Change: And research tax credits for $3 3 million.

Bart Van Rijn: R&D expenses consist primarily of preclinical, clinical and manufacturing expenses related to development of MBTXR3 and totaled 40.5 million euros for the 12-month period ended December 31, 2024 as compared to 38.4 million for the 12 months ended December 31, 2023. A 5% increase in net R&D expenses was primarily due to an increase of clinical development activities driven by the cost related to nanowave 312 and the phase 1 multicore trial of RT-activated MBTXR3 followed by anti-PD-1 checkpoint inhibitors, also known as study 1100, as well as the full-year impact of R&D positions that were recruited in 2023. When we turn our attention to selling general and administrative expenses, these were 20.5 million euros for the year ended December 31, 2024 compared to 22 million for the year ended December 31, 2023.

Speaker Change: R&D expenses consist primarily of preclinical clinical and manufacturing expenses related to development of MBT XR three.

Speaker Change: Totaled 45 million euros for the 12 month periods ended December 31, 2024, as compared to $38 4 million for the 12 months ended December 31, 2023, 5% increase in net R&D expenses was primarily due to an increase of clinical development activities.

Speaker Change: Driven by the costs related to <unk> hundred 12, and a phase one multi cohort trial of Archie activated.

Speaker Change: <unk> three followed by anti PD, one checkpoint inhibitors also known as study <unk>.

Speaker Change: 700, as well as the full year impact of R&D positions that were recruited in 2023.

Speaker Change: When we turn our attention to selling general and administrative expenses. These were 25 million euros for the year ended December 31, 2024 compared to $22 million for the year ended December 31 2023.

Bart Van Rijn: 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 1.9 million euro in total. Net loss attributable to shareholders was €68.1 million, a year-over-year increase of 72%, or €1.44 per share for a 12-month period ended December 31, 2024, which is primarily attributable to the one-off negative revenue recognition accounting impact, which again was a non-cash item. This compares to a net loss of €39.7 million or €1.08 per share for the year ended December 31, 2023.

Speaker Change: The 7% year over year decrease was mainly due to one off fees incurred in 2023, consisting of license agreement execution and equity issuance related legal expenses next two one off fees paid to financial advisor for $1 9 million in total.

Speaker Change: Net loss attributable to shareholders was euro $68 1 million a year over year increase of 72% or one.

Speaker Change: <unk> 44 per share for the 12 month period ended December 31, 2024, which is primarily attributable to the one off negative revenue recognition accounting impact, which again was a noncash item.

Speaker Change: This compares to a net loss of $39 7 million euro or one euro <unk> eight per share for the year ended December 31 2023.

Bart Van Rijn: As we look at cash and cash equivalents, as of December 31, 2024, Nanobiotix had 49.7 million in cash and cash equivalents, compared to 75.3 million euro as of December 31, 2023. Based on the current operating plan and financial projections, Nanobiotix anticipates that the cash and cash equivalents of 49.7 million euro as of December 31, 2024, will fund its operations into mid-2026.

Speaker Change: As we look at cash and cash equivalents as of December 31, 2024, <unk> had $49 7 million in cash and cash equivalents compared to $75 3 million Euro as of December 31, 2023.

Speaker Change: Based on our current operating plan of financial projections, <unk> anticipates that the cash and cash equivalents of $49 7 million Euro as of December 31, 2024 will fund its operations into mid 2026 to conclude we have a disciplined capital allocation approach and our recently amended licensing deal.

Bart Van Rijn: To conclude, we have a disciplined capital allocation approach and our recently amended licensing deal arrives 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 MBTX R3 or J&J 1900, and are focused on bringing this first-in-class radio enhancer to the market together with our partners.

Speaker Change: The structure that puts the company on a path towards a sustainably financed company subject to milestones are regulatory approvals coming in positive.

Speaker Change: We are very excited regarding the potential of <unk> III or J&J 19, hundreds and are focused on bringing this first in class radio enhancer to the markets to get out with our partner <unk>.

Laurent Levy: And now I will turn the call back to Laurent. Laurent? Thank you, Bart. Let's see what's coming in the next 18 months for nanobiotics.

Speaker Change: Now I will turn the call back to La Laura.

Laura: Thank you Bob.

Speaker Change: Let's see and what's coming in the next 18 months for Fernando Biotechs.

Laurent Levy: As you can see on slide 16, we expect to get a very important milestone next year, namely the end of recruitment of the ongoing phase 3 in head and neck. That should lead, assuming the data are positive, to potential registration. There's also the stage 3 randomized phase 2 in non-small-cellular cancer that J&J has started that should start reading in the not-too-distant future.

Speaker Change: Can see on slide 16.

Speaker Change: We expect to get a very important milestone next year and namely.

Speaker Change: And if recruitment of the ongoing phase III in head and neck that should lead assuming the data positive two potential registration.

Speaker Change: There is also the stage three randomized phase III in non small cell lung cancer that J&J has started that should start really digging in 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.

Laurent Levy: But what's coming for this year is more data. And starting with the head and neck refractory patients that are eligible to PD-1, 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 2015. The non-small cell lung cancer trial coming from AFDA 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 second part of the year, we're waiting also the first data coming from the last cohort.

Speaker Change: First line also go online.

Speaker Change: Third line treatment and we expect to get data on those two cohort by the end of 'twenty five.

Speaker Change: Small cell lung cancer trial coming from FDA have been published just a few 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 midyear this year and for second.

Speaker Change: Part of the year, we're waiting also the first data coming from the last cohort.

Laurent Levy: coming from the 1100 trial, which are patients that receive multiple IOTreatment and some others that got refractory and then we have injected our product plus radiation. continuation of PD-1 to see if we can rescue this patient. And most of the patients here have been melanoma patients, and we're really eager to present this data. And finally, coming from MD again, the esophageal phase one 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 waiting some of the key important milestone in locally advanced head and neck cancer, phase three, or lung stage three, randomized phase two, run by change.

Speaker Change: From the level in great trial, which are patient that receive multiple.

Speaker Change: I O treatment and some others that got refractory and then we have injected a product plus radiation.

Speaker Change: Continuation of PD, one to see if we can rescue this patient and most of the patients have been melanoma patients and we're really eager to present this data and finally coming from NDA again.

Speaker Change: <unk> phase one first data we will start updating this program by the end of this year. So as you can see there would be a lot to say.

Speaker Change: Now to the end of the year, while waiting some of the key important milestone.

In locally advanced head and neck cancer phase III, all lung stage III randomized phase II run by J&J.

Laurent Levy: 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&J. It does evolve and progressing really well. We have continued also to show the potential and opening the potential of NBKXR3 in multiple indications.

Speaker Change: In a nutshell for today, what we would like to take away.

Speaker Change: First of all we're moving forward with the partnership with J&J, It does evolve and progressing very well.

Speaker Change: We have continued also to show the potential and opening of the potential of <unk> in multiple indications.

Laurent Levy: This year, or last year, sorry, has been a good time to introduce our new platform, Curadat. And equally importantly, not only we are growing our different options to develop products to help patients, but we're really moving towards 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 readout and more.

Speaker Change: This year, our last year, sorry has been a good time to introduce a new platform paradigm.

Speaker Change: And.

Speaker Change: Equally importantly, not only we are growing our different option to develop products to help patients, but we are really moving towards financial sustainability and growth for the company and last year, we've been clearly strengthened our financial position.

Speaker Change: And finally, we're coming with <unk>.

Speaker Change: End of the year, where we expect many more clinical readouts and more to come.

Unknown Attendee: So with that, I'll conclude the first part and we'll open the session for Q&A. Thank you. As a reminder to ask a question please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 and 1 again. Once again please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 and 1 again.

Speaker Change: So is that I will conclude the first part and we will open the session for Q&A.

Speaker Change: Thank you.

Speaker Change: As a reminder to ask a question. Please press star one and one on your telephone and wait for your name to be announced until we until your question. Please press star one and one again once again, please press star one and one on your telephone and wait for your name to be announced until we've got your question. Please press star one and one again.

Yanzhi Li: We are now going to proceed with our first question. The questions come from the line of Jonathan Chang from LearWink Partners. Please ask your question. Hi, good morning. This is Yanzhi Li for Jonathan Chang. Thanks for taking my questions. So I have two questions.

Speaker Change: We are now going to proceed with our first question.

Speaker Change: The question has come from the line of Jonathan Chang from Leerink Partners. Please ask your question.

Speaker Change: Hi, good morning.

Speaker Change: Yes Lee.

Speaker Change: Jonathan Chang Thanks for taking my questions.

Yanzhi Li: So the first one, could you provide more details on the recently initiated phase two CONVERGE study by J&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.

Speaker Change: So I have two questions. The first one could.

Speaker Change: Could you provide more details on the recently initiated phase III convert study by TNT specifically.

Speaker Change: Specifically.

Speaker Change: When can we expect to see the initial data and what factors keeps your competence in the study's potential for success.

Speaker Change: Thank you.

Laurent Levy: 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 to define when I 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 NBTXR3 could make a difference here. I think it's in going to the continuation of having consistently showing a 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 3 patient and resectable, that usually get the pacific regimen, which is radiation, chemo, and followed by PDR1, assuming they did not progress in between, there's still a low bar in terms of local response.

Speaker Change: Thank you.

Speaker Change: Unfortunately for now we can't sell them anything.

Speaker Change: Anything more that the trial has started and progressing well and we will come to a partner to to define when I will be the first readout of this trial now.

Speaker Change: Concerning the other part of the question about <unk>.

Speaker Change: Wireless population and higher what should we expect on where do we think <unk> century could could make a difference here I think it's in going to the continuation of having consistently showing very good local control induced by a product when combined with radiation and in this specific population of locally.

Speaker Change: Advanced non small cell lung cancer, so stage III patient and Resectable, that's usually get the Pacific regimen, which shades radiation chemo and followed by PDL, one assuming did enough progress in between.

Speaker Change: There's still a low bar in term of a local response and more generally in oncology. When you have good local response for locally advanced cancer patients.

Laurent Levy: And more generally in oncology, when you have good local response for locally advanced cancer patients without MET, then this translates into PFS and NOS. 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.

Speaker Change: Without met Dan this translate into PFS and OS what we have seen in head and neck, what we see is our indication.

Speaker Change: So clearly the point here is to bring much better local control to dose patients. So that's the context of this from the mice trial now what we start seeing across different indication as I mentioned show already a good local control brought by NBC ex factory and we think the recent data.

Yanzhi Li: 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 NBTXR3 and we think the recent data generated by MDA is also a good sign of what could happen in the converged study. Understood. Thank you. Very helpful.

Speaker Change: Generated by MDA is also.

Speaker Change: A good sign of what could happen to.

Speaker Change: It comes out study.

Speaker Change: Understood. Thank you very helpful and my second question.

Yanzhi Li: And my second question is about 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. So, end of last year, we announced the completion of the. Phase 1 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 MDA is working on that aspect right now.

Speaker Change: About the upcoming pancreatic cancer data presentation.

Speaker Change: We're curious how will the information presented there that different from the press release last year and if the results are promising with the next step would be for <unk>.

Speaker Change: Indication thank you.

Speaker Change: Thank you.

Speaker Change: End of last year, we announced the completion of the.

Speaker Change: Phase one that was including an escalation bought an expansion vault and just gave the topline overall survival for the patients. So what we should expect a readout for this is the full data, including efficacy safety some of the potential biomarkers that have been used so.

Speaker Change: MDA is working.

Laurent Levy: 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 cohort. And this new cohort is about giving the full standard of care to patients. Just as a reminder, the first part of the trial was patients that get chemoinduction, then followed by radiation plus NVT-XR. 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 known model faction, a better synergy and even more efficacy than what we've been seeing in the first part of the trial.

Speaker Change: On that aspect right now there is.

Speaker Change: Is already a next step that has started when we announced that FDA approved an amendment to the protocol that is adding a new costs.

Speaker Change: And this new cohort is about giving the full standoff gastric patients just just as a reminder, the first part of the trial.

Speaker Change: Patients that get chemo induction, then followed by radiation plus NB gx artery.

Speaker Change: Now.

Speaker Change: That's not the full standard of care that those patients usually received as they're usually do chemo induction radiation plus chemo. So in this expansion path. We have added the chemo on the top of radiation plus NBC XR tree and therefore should expect.

Speaker Change: According to the existing nonmanufacturing, a better synergy and even more efficacy than what we've been seeing in the first part of the trial. So this part this part of the <unk> team.

Yanzhi Li: So this part of the trial is rotating, and we will tell soon when we should expect data. Thank you. Very helpful. Thank you.

Speaker Change: And we will tell soon when we should expect data on that.

Speaker Change: Thank you very helpful.

Shan Hama: We are now going to proceed with our next question. And the questions come from the line of Shan Hama from Jeffreys.

Speaker Change: We are now going to proceed with our next question.

Shanghai MA: And our question comes from the line of Shanghai MA from Jefferies. Please ask your question.

Shan Hama: Please ask your question. Hi there, thank you for taking my questions. I'm just on. What portion of costs are you still liable for for the nanarray study and what are they related to?

Speaker Change: Thank you for taking my questions.

Speaker Change: Just.

Speaker Change: Yes.

Speaker Change: Of course are you still liable for the study.

Speaker Change: Related to and how much you can disclose.

Shan Hama: And secondly, oh, I appreciate this might be more. What's the most recent communication you've had with FDA on the Nanoray program? I think the recent shake-up in the administration.

Speaker Change: And secondly.

Speaker Change: I appreciate this might be more with J&J responsibility.

Speaker Change: The most recent communication <unk> had with FDA on the non array program I think the recent shakeup.

Speaker Change: And the administration.

Unknown Attendee: Unidentified Speaker... So there may be delays... Thank you.

Speaker Change: Of course concerns that some programs.

Speaker Change: Hi.

Speaker Change: And meetings.

Speaker Change: Have you been hearing thank you.

Laurent Levy: 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&J is doing the same. As our program is already well engaged, we don't have experience, to the best of my knowledge today, any delay in meetings or interaction. So things look normal today.

Speaker Change: Thank you.

Speaker Change: So maybe let me take the second question and I'll pass the mic to <unk> to answer the first one.

Speaker Change: I mean, we interacted with the FDA authorized <unk> on different matter and J&J.

Speaker Change: Is doing the same.

Speaker Change: As our program already well engaged.

Speaker Change: We don't have experience to the best of my knowledge today any G laid in meetings our interaction.

Speaker Change: So things look.

Speaker Change: Normal to date.

Bart Van Rijn: Thank you, Laurent. Happy to follow on. Thank you, Sean, for the question. With regards to the remaining costs with nanobiotics, that is relatively immaterial as we've guided the public. The vast majority of the costs are now with J&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, 2026 and 2027 that remain on our end. 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-2026, but the removal of the vast majority of this Phase 3 trial cost will benefit us beyond mid-2026, and that burn rate will come down if one takes a look at our annual R&D expense, of which the majority relates to...

Speaker Change: Yes.

Speaker Change: Thank you Laura and happy to follow on thank you Sean for the question.

Speaker Change: With regards to.

Speaker Change: The remaining costs with no <unk>.

Speaker Change: It is.

Speaker Change: Relatively immaterial as we've guided the public the vast majority of the costs are now with.

Speaker Change: J&J that has taken.

Speaker Change: <unk> taken over the obligation to funds.

Speaker Change: Or to the exchange of milestones that we announced two weeks ago.

Speaker Change: That may lead to some payments in.

Speaker Change: 2025, 2026, and 2027 that remain on our end.

Speaker Change: They're in the single digits.

Speaker Change: In those respective years in our notes.

Speaker Change: Impacting the cash runway in a meaningful way, we've guided the cash runway to mid 2026.

Speaker Change: But the.

Speaker Change: Removal of the vast majority of this phase III trial costs will benefit us beyond mid 2026.

Speaker Change: The burn rates will come down.

Speaker Change: If one takes.

Speaker Change: Look at our.

Speaker Change: R&D expense of which the majority relates to.

Bart Van Rijn: The NanoRay 3.12, directly or indirectly, one should expect that we will have a very attractive cost run rate post-mid-2026.

Speaker Change: <unk> hundred 12 directly or indirectly one should expect that we will have a very attractive cost run rate post mid 2026.

Unknown Attendee: Thank you.

Speaker Change: Yeah.

Michael Schmidt: 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. Hey guys, good morning. I just had a bigger picture question.

Thank you.

Speaker Change: We are now going to proceed with our next question.

Speaker Change: And the questions come from the line of Michael Schmidt from Guggenheim Securities. Please ask your question.

Speaker Change: Hey, guys good morning.

Speaker Change: I just had a bigger picture question. So now that the <unk> Rx III program has essentially transitioned fully to J&J operationally and financially.

Laurent Levy: So now that the NBT RX3 program has essentially transitioned fully to J&J operationally and financially, I guess, as you think about the company longer term, what are some of the R&D initiatives internally at Nanobiotix that that you think could create additional value longer term beyond Thanks Michael for the question. So maybe, sorry, 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&J now is taking a good part, a majority of what is happening with NBTXR3, with the CONVERGE trial, with the transfer of the 312 and so on.

Speaker Change: I guess.

Speaker Change: As you think about the company longer term what are some of the R&D initiatives internally at <unk> bionics.

Speaker Change: They could create additional value longer term beyond <unk>.

Speaker Change: Thanks, Michael for the question.

Speaker Change: So maybe.

Speaker Change: Alright, maybe first of all let's say that we're not yet done with NBC et cetera, we still have a lot to do you're fully right. When you say that J&J is sticking.

Speaker Change: A good part the majority of what.

Speaker Change: Is happening with <unk> was to conduct trials was the transfer of the tree 12, and so on but this transfer is not yet done.

Laurent Levy: 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, around pre-clinical, around preparing everything that should go and will go in the dossier for registration. So outside the 312, which is today a big part of the investment in resources of nanobiotics that J&J is taking, there's still a lot in parallel. And this, we think, will continue for the coming few years.

Speaker Change: As we mentioned should be in Q3, this year and there's still a lot to do around the manufacturing around clinical around preparing everything that should go and will go in the dossier for registration so.

Speaker Change: Outside to treat well, which is today a big part of the.

Speaker Change: Investment and resources of nano diodes, exactly know J&J staking, there's still a lot in parallel and this we think will continue for the coming few years now.

Bart Van Rijn: Now, it is true that this shift of the 312 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 Caradigm platform, which is the platform we want to push after NBTXR3, 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. So I think you mentioned earlier, but how much additional R&D spend in 2025 and 2026 will be on NBT XR3 versus other programs?

Speaker Change: It is true that this.

Speaker Change: Shift of the <unk> 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 audio platform.

Speaker Change: Mainly the paradigm platform, which is the platform.

Speaker Change: Want to push after envy, TX our tree, which is a very broad applicable platform not only to potential early deal and partnership but also to develop on your internal pipeline, but we expect to give more detail on that before the end of this year.

Speaker Change: And so I think you mentioned earlier about how much additional R&D spend in 2025, and 2026 would it be on <unk> XR three versus other programs.

Bart Van Rijn: bot212 So what will remain essentially is the 1100 study, M.D. Anderson, preclinical and discovery work. as well as Curidime. Each of those are single-digit millions so the burn will come down quite significantly on the R&D side with the... 312 Study, making up the majority of the R&D spent. So that is millions per quarter less. The beauty of the Curidime 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.

Bob: Bob do you want to.

Speaker Change: I'll take that one.

Speaker Change: There was a meeting.

Speaker Change: So what will remain essentially is the 1100 study MD Anderson.

Speaker Change: Clinical and discovery work.

Speaker Change: As well as secured on.

Speaker Change: Each of those are single digit millions so the burn will come down.

Speaker Change:

Speaker Change: Quite significantly on the R&D side with.

Speaker Change: The.

Speaker Change: Please tell study making up the majority.

Speaker Change: Of the of the R&D spend.

Speaker Change: So that is millions per quarter less.

Speaker Change: The beauty of the <unk> program.

Speaker Change: As explained to the market.

Speaker Change: It's a platform that can be partners, whether it's with existing.

Speaker Change: New drugs.

Speaker Change: Drugs that have failed.

Speaker Change: So we expect that the burn will be very efficient in that regard it will go up versus what it is now but.

Bart Van Rijn: It will go up versus what it is now, but it will, on a net basis, with the removal of the Phase III liability, you know, be significantly less on a net basis going forward. Thank you.

Speaker Change: It will on a net basis.

Speaker Change: With the removal of the phase III liability.

Speaker Change: Be significantly less on a net basis going forward.

Michael Schmidt: Thank you, Michael.

Thank you.

Swayampakula Ramakanth: We are now going to proceed with our next question. The questions come from the line of Swayampakula Ramakanth from HCW. Please ask your question. Thank you. This is RK from Hephzibah Inuit.

Michael Schmidt: Thank you Michael.

Michael Schmidt: We are now going to proceed with our next question.

Speaker Change: The question comes from the line of <unk> Rama from H C. W. Please ask your question.

RK: Thank you this is RK from hits at run rate.

Swayampakula Ramakanth: Good afternoon, Laurent and Bart. So a couple of quick questions here. So, this is for Bart, you know, you were talking about the runway, which currently stands till mid-2026, and you were also saying, you know, there are potential ways for you to extend it into 2027. So, what could be the potential non-dilutive ways, and also, you know, how much of a gap is there, you know, for you to fill so that you can take it up to 2027 or into 2027 from where it stands currently? Thank you, RK. So. We feel that the enterprise value significantly disconnected with the market cap, therefore, dilutive options are not our preference.

Speaker Change: Good afternoon, Brian and Bob Hombach.

Speaker Change: So a couple of quick questions here.

Speaker Change: So.

Speaker Change: This is for Bart.

Speaker Change: The U S.

Speaker Change: Talking about.

Speaker Change: Runway, which currently stands still in mid 2026 and <unk>.

Speaker Change: And you are also saying there are potential ways for you to extend that into 2007.

Speaker Change: No.

Speaker Change: And what could be.

Speaker Change: The potential non dilutive ways and also.

Speaker Change: How much of a gap is there.

Phil: For you to Phil.

Phil: You can take it up to 227 not limited only to two seven.

Phil: From a man it stands currently.

Phil: Okay.

Phil: Thank you.

Phil:

Phil: So.

Phil: We feel that.

Phil: The.

Phil: Enterprise.

Phil: Values significantly disconnected with the market kept therefore.

Phil: Dilutive options are not our preference.

Bart Van Rijn: We have EIB debt in our cap structure and any more debt we believe is not the ideal way to go about things. but other monolithic 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&J. We expect that to continue, so it is a very interesting asset for many of the providers in that space. As our burn will come down quite significantly, we don't need a lot of money.

Phil: We have EIB debts.

Phil: Our cap structure.

Phil: And adding more debt, we believe is not the ideal.

Phil: Way to go about things.

Phil: But although non dilutive financing.

Phil: Options.

Phil: S oil to financing.

Phil: Belief holds promise.

Phil: For the company given the type of asset is this just to remind it's a very versatile asset Luann mentioned.

Phil: Coal, it's tumor agnostic combination gnostic targeted milkshake.

Phil: We see significant engagements in investments by our partner J&J.

Phil: We expect that to continue so it is a very interesting assets.

Phil: For many of providers in that in that space.

Phil: As our burn.

Phil: It will come down.

Phil: Quite significantly we don't need.

Bart Van Rijn: 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 harbour because there's tremendous value in this asset that needs to result in value creation for our shareholders. And we want to 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 many indications should data readouts people's.

<unk>.

Phil: Money would be.

Phil: Low teens.

Phil: To get into 2027, it just behooves us at this point in time to remove the finance overhang.

Phil: Get into safe Harbor, because there's tremendous.

Phil: Well you in this asset that needs too.

Phil: Result in.

Phil: Value creation for our shareholders and we want to make sure that we do that so that.

Phil: There is no.

Phil: Finance overhang.

Phil: People can just appreciate the technology the versatility of hits.

Phil: That is partnered with.

Phil: The partner that we believe is.

Phil: An ideal partner for those assets and bring it.

Phil: Hopefully in many indications shoots data readouts people stuff.

Swayampakula Ramakanth: Thank you for that Bart.

Doug: Thank you for that Doug.

Swayampakula Ramakanth: And then Laurent, just thinking about R3 for a second. you know. Having seen the data that we have seen so far, you know, both on the safety side and on the efficacy side. You know, to me, there doesn't seem a real reason why this should not get into the into the market. You know, 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, you know, what could be the potentially the reasons why it cannot get to the market? You know, 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?

Phil: And then at Orion.

Phil: Just thinking about.

Phil: <unk> III for a second.

Phil: No.

Phil: Uh huh.

Speaker Change: Having seen the data that we have seen so far.

Speaker Change: Both on the safety side and on the efficacy side.

Speaker Change: And to me that doesn't seem like a real reason why.

Speaker Change: This should not get into the into the market.

Speaker Change: Got.

Speaker Change: It may take a little bit of time, but there is no reason to think that it should not get to the market.

Speaker Change:

Speaker Change: Howard.

Speaker Change: What could be the potential at the reasons why it cannot get to the market.

Speaker Change: I was just thinking about it.

Speaker Change: Based on what we know about the molecule.

Speaker Change: <unk>.

Speaker Change: I feel quite confident about that.

Speaker Change: Other than the timing part of it are there any other things that.

Speaker Change: And I'm being blindsided.

Laurent Levy: Well, thank you, RK, for the question, the $10 billion 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, it's 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 impactful risk that the biotech is facing is behind us.

RK: Thank you RK for further question 10 billion dollar question.

RK: Well.

RK: 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.

RK: Indicated manufacturing is always a risk.

RK: Getting some first randomized data.

RK: It was a risk until you have to them not having a partner to market the products how 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.

RK: Is.

Laurent Levy: So I will say that we are in a very de-risked situation right now. Now, there's never 100% 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 the next big inflection point and to, on our side, help GenG to move as fast as they can and to bring this product to market.

RK: Behind us.

RK: So I will say that we are in a very de risks our situation right now.

RK: I've never under 8% guarantee in any any of the things so.

RK: I think what we should just do is wait is not too much time to wait now too to get to next big inflection point and <unk>.

RK: Two on outside help J&J to move as fast as they can and to bring this product to market.

Swayampakula Ramakanth: Thank you for that.

Laurent Levy: And then the last question from me is also on the curatime 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 a, you know, a clinical program? Is it resources or is it time in the sense getting all the material together, you know, to start a program? Well, I think it's essentially timing. We have enough resources to push this program. As Bart mentioned, at the 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.

RK: Thank you for that and then the last question from me is on the cure them asset.

RK: Probably have asked this question in the past.

RK: What's what's the gating.

RK: That needs to get done so that you can initiate that.

Speaker Change: Our clinical program.

Speaker Change: Is it is it resources and time to.

Speaker Change: Time and defense getting all the material together to startup program.

Speaker Change: Well I think it's essentially timing we have enough resources to push this program as Bob mentioned at this stage of development. It is it does not.

Speaker Change: Cost.

Speaker Change: If money, but also has we want to reemphasize the partnership activity on that then probably it will be a big part of it that will be.

Speaker Change: <unk> done on all of those times.

Laurent Levy: 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 and on their way.

Speaker Change: So.

Speaker Change: We're working on our internal pipeline and also.

Speaker Change: <unk>.

Speaker Change: Starting interacting with many biotech and pharma we have good number of MCA is already signing on their way.

Unknown Attendee: So things are moving and we hope I will give much more info by the end of this year. Thank you. Thanks for taking all my questions. Thanks, Hake. Thank you. As a reminder to ask a question, please press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. We are now going to proceed with our next question.

Speaker Change: So it seems things are moving and we hope and I will give a much more in full by the end of by the end of this year.

Speaker Change: Thank you thanks for taking all my questions. Thanks hockey.

Speaker Change: Thank you as a reminder to ask a question. Please press star one and one on your telephone and Whitfield name to be announced until we've got your question. Please press star one and one again.

Speaker Change: We are now going to proceed with our next question.

David Dai: The questions come from the line of Eric Musunza from UBS. Please ask your question. Hello, Eric, your line is open. You may ask a question. Actually, this is David Dai from EBS. Can you hear me? Yes, David. Yes, great.

Speaker Change: The.

Speaker Change: <unk> come from the line of Eric <unk> from UBS. Please ask your question.

Speaker Change: Hello, Eric Your line is open you may ask your question.

Speaker Change: David and Doug.

Speaker Change: UBS.

Speaker Change: Can you hear me, yes, David.

David Dai: So, um, yeah, just actually two questions for me as well. So regarding the memory 312 file, um, you know, so you're planning to enroll patients with and without statuximab. These patients who receive statuximab will likely have a longer survival. Could you tell people to understand what percentage of patients are going to be enrolled with statuximab and what percentage will not have statuximab? And just, you know, curious if there's going to be a cap in terms of patients who are, who have the statuximab, you know, background. Thanks, David. So... Cetuximab is not the biggest used drug in head and neck when it comes to frail and elderly patients.

Speaker Change: Yes, great. So.

Speaker Change: Yes, just actually two questions from me as well so regarding to generate 312 trial.

Speaker Change: So you plan to enroll patients with and without that took some of his patients who receive statistics that I would like to have a longer survival could you just focus help us understand what percentage of patients are going to be enrolled with cetuximab and what potential will not obstetrics them out.

Speaker Change: I'm curious if there is going to be a cap in terms of patients who are.

Speaker Change: Who have the statistics on that.

Speaker Change: Background.

Speaker Change: Thanks, David.

Speaker Change: <unk> Mab.

Speaker Change: It's not the biggest used drug.

Speaker Change: In head and neck, when it comes to frail and elderly patients.

Laurent Levy: 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 use 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, the Cetuximab use is detrimental versus radiation alone.

Speaker Change: Nevertheless, that's something that is in the standoff care guideline, but when you look at it.

Speaker Change: 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 this choice opened for physicians to use it on out so that's one.

Speaker Change: And in order to make sure that the trial is balance and there is no bias. We've made <unk> my views as a stratification factor. So we should assume a balance number of patients getting each in both arms.

Speaker Change: Now why is that <unk> is not used that matching those patient is because when you look at the detail of the Bono paper, what you see is that for <unk>.

Speaker Change: People do you said 60, my views decree mental versus radiation alone.

Laurent Levy: So, of course, looking at the overall data, you see a benefit for Cetuximab. But this benefit is exclusively driven by younger patients. So 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 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 NBTXR3 or better if we anticipate synergies. So that's why we don't think cetuximab in this trial will play a key role.

Speaker Change: So of course looking at the overall data you see a benefit for Citrix, you, Matt, but theres benefit is exclusively driven by younger patients.

Speaker Change: At the end of the day, we think that Cetuximab in this trial, we will have a neutral effect we.

Speaker Change: We should not expect more efficacy coming from at all.

Speaker Change: Little plus but if there is some.

Speaker Change: Small benefit we should assume that this benefit will be at the minimum equal in the arm with <unk> or better if we anticipate synergies.

Speaker Change: So that's why we don't think Citrix team, having this trial will play a key role.

David Dai: That's really helpful.

Laurent Levy: And then it's another question on the upcoming data readout. There are many updates in 2025, including the phase one data from the relapse metastatic head and neck cancer in combination with PDU1. Can you just share with us mechanistically, how do you think R2 will be additive to PDU1 to exert better systemic benefit for those metastatic patients? Sure. First of all, before getting to the benefit of systemic activity of MBTX artery, I just want to remind that for all patients getting PD-1, the first time they will get PD-1, they're usually one-third of those patients that are only locally relapsed, one-third that will have local relapse plus MET, and a third only will have MET only.

Speaker Change: Alright, Thats really helpful. And then just a question on the upcoming data readout. There are many updates at <unk>, 5%, including the phase one data from the relapsed metastatic head and neck cancer in combination with PD one.

Sure sure with Us Mechanistically, how do you think <unk> will do well.

Speaker Change: You will be additive to Pee went to exert better systemic benefit for those metastatic patients.

Speaker Change: First of all before getting to the video fit of systemic activity of <unk>, just want to remind that for all patients getting PD one.

Last time, they will get PD, one, they're usually when sort of those patients that are only locally relapsed. One so that will have local relapsed plus Matt and certainly we'll have met only.

Laurent Levy: And most of the patients, the 60% 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-1, 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.

Speaker Change: And most of the patients to 60% I mentioned previously and beyond they are coming from the failure of previous lines of treatment.

Speaker Change: So before getting into any systemic activity of <unk>, we should just remind that those patient getting PD, one also need and primarily need a local control.

Speaker Change: That's what.

Speaker Change: <unk> mentioning quite repeatedly when we talk to them, that's systemic control in head and neck and metastases patients. So Luckily relapsed plus met is good but usually does not translate into.

Speaker Change: Our direct link to PFS and overall survival Theres always this need and an important need to control the local Jamal and Thats, where we know <unk> could play a key role first.

Laurent Levy: And that's where we know MBTXR3 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 patient just based on local control. Now, when it comes to systemic, we've been proven in multiple study 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 Welsh. 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 1100 is really those two things, local control and systemic control.

Speaker Change: So even if we don't look at the systemic effect, we have a strong potential to improve outcomes for patients just based on local control.

Speaker Change: Now when it comes to systemic we've been.

Speaker Change: Proven in multiple study with MD Anderson, that's when we combine our tree to radiation versus radiation alone. We can trigger a much deeper systemic immune response.

Speaker Change: With different mechanics, and this has been fully extended studied in preclinical model by James Welch.

Speaker Change: So what we start seeing and that's part of what we would like to show in the next set of data we will.

Speaker Change: Explore two for the 11 and drag 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 building to two local control not to what extent we have the systemic control. That's something we are we are exploring.

Laurent Levy: 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 Dai: That's really helpful. Thank you so much and congrats on the progress. Thanks, David.

Speaker Change: That's really helpful. Thank you so much and congrats on progress. Thanks.

Speaker Change: Thanks, David.

Unknown Attendee: There are no further questions at this time.

Okay.

Laurent Levy: I will now turn the call over to Dr. Levy for his closing remarks. Thank you. Listen, thank you, everyone. It was another fruitful conversation. We have plenty of news to deliver this year, so we're going to go back to work and prepare that for you. Thank you for your attention, and I will wish you a very good day, and let's talk soon.

Speaker Change: There are no further questions at this time I would like to turn the call over to Dr. Levy for his closing remarks.

Speaker Change: Thank you.

Dr. Levy: And thank you everyone.

Speaker Change: Fruitful conversation.

Speaker Change: We will have plenty of news to deliver this year. So are we going to go back to work and prepare that for you.

Speaker Change: You for your attention and I will wish you a very good day and let's talk soon.

Unknown Attendee: Ladies and gentlemen, this concludes today's presentation. Thank you once again for your participation. You may now disconnect your lines. Thank you and have a great day.

Speaker Change: 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.

Speaker Change: Yeah.

Speaker Change: [music].

Speaker Change: Okay.

Speaker Change: [music].