Onward Med Nv

Good morning, good afternoon everyone and welcome to our Onwards webcast following the publication of our results earlier today. As usual, before we get started, please take a moment to read our disclaimer. Today's presentation includes forward-looking statements which should be considered with the appropriate level of caution as outlined on this page. The slides and its recording will be available on our website after the call. Today's speaker includes Dave, our CEO, Sean Chiara, our Chief Commercial Officer, and Amory Fraser, our Senior Finance Director. As usual, we go through a comprehensive update before opening for questions. You may submit your questions verbally or via the Q&A module on the platform. With that, I'll hand over to Dave.

Thank you, Seb. So it was an eventful quarter four onward. Since our last update, we exceeded 1.5 million euros in quarterly revenue. We received CE mark and U.S. home use clearance from FDA for the Archaic system, and we raised 50 million euros in new equity capital. So let me just run through these in a bit more detail, and then I'll also go into further detail during the presentation that follows. So most importantly for most of you is commercial traction. So we continue to see acceleration of ArcheX in U.S. clinics. We sold 40 units in Q3, and we exceeded 1.5 million euros in quarterly revenue for the first time. Actually, we hit 1.7 million euros, which is nearly a $2 million run rate. It's $1.96 million at today's exchange rates. ArcheX systems are now available at over 60 U.S. clinics. We also achieved several important regulatory milestones. We received CE mark certification for ARC-EX for use in both clinics and homes. We completed UK MHRA registration for the ARC-EX system, meaning we can now promote the device in the United Kingdom. We received US FDA investigational device exemption, or IDE, for the ARC-IM system so that we can start the EmpowerBP clinical study. We received ULmark certification, which is an electronic safety certification for the Archaic system. And we received FDA 510K clearance for home use in the U.S., which greatly expands our market opportunity. We continued our science and technology leadership, announcing simultaneous publications in nature and nature medicine. And there was another publication on the LIFT home study results in neurology clinical practice. From a company perspective, we raised over 50 million euros in new equity capital, anchored again by Autobach and also anchored by Invis and ASR, and we strengthened our leadership team with the appointment of new senior executives. Let's start with more information on our commercial traction. So you've seen this slide before. This is a demand indicator. We continue to observe very high inbound global interest, about And these numbers are unsolicited inbound requests for more information or for a product evaluation. So thus far, more than 5,000 global leads have been collected, more than 3,300 collected in the U.S. alone, and 430 of them are collected from U.S. clinics. So nearly every U.S. clinic whom we consider a target has reached out to Onward to learn more about this device. Unsurprisingly, our sales are also increasing, reflecting that demand. You know, in the first half, it was a limited launch where we sold precisely the number of units we intended. And then we pre-announced our Q3 results that we had sold 40 units in Q3, placing our year-to-date units sold at 70 and our penetration into over 60 U.S. clinics. We expect the demand in Q4 to remain strong, to be sustained. And there are two important catalysts that may provide upside in Q4, but will largely be drivers for significant growth in 2026. That being the CE mark approval that allows us to market device in Europe, and then the 510k that we recently received for home use in the US. And I'd now like to turn things over to Sean Chara, our new chief commercial officer, to walk through a couple of slides on our commercialization.

Thank you, Dave. We're obviously pretty excited about the two big catalysts that we have in front of us to put us in a great position for accelerated growth in 26. The first of those, as you mentioned, is the European launch. So, as everybody knows, we received our CE mark in September, and since then, we've gone on to complete the additional regulatory work to secure clearance and registration in both Switzerland and, as Dave mentioned, the United Kingdom. Our launch is underway. Our initial focus, as you see here on the slide, will be on the critical cluster of DACH, so Germany, Switzerland, and Austria. To that, in this initial launch phase, we will add the Netherlands and the United Kingdom, so two countries where we've had longstanding partnerships and in clinical trial activity. As we look to expand across Europe, we're going to do that with a combination of direct sales, where we think that's most critical, as well as through distributor relationships, where we think that is most appropriate. We have our leadership in place today. We have additional hiring underway. We commenced selling activity immediately upon the CE mark clearance, and we look forward to first sales here in Q4 and launching some of these early European centers in the fourth quarter. The second of the big growth catalysts is on the next slide. I would say certainly equally, if not more important, and that is our recent home use clearance in the United States, which is all of a week old at this point. Initial response from the field has been fantastic. Our inbound leads are up threefold over our typical levels, and our clinic partners are telling us they have clients actively reaching out to them to talk to them about how to obtain a home use unit. Being able to extend this therapy into the home is obviously a very big deal for the community. For people with limited mobility, being able to extend the therapy into the home makes it more accessible. And we know from the lift home trial that sustained engagement and use of the therapy is important not just for maintaining benefits, but potentially extending benefits as well. The home use trial builds on the tremendous success we've had in the clinic. As Dave mentioned, we've got a footprint of over 60 clinics. As people with spinal cord injury will need to get exposure to the therapy in the clinic to integrate it into their rehab programs, to establish the appropriate stimulation parameters that are optimized to them, all of that is done in the clinic. So having this really large base already in place gives us a really solid foundation in the United States to begin the extension of the therapy into the home. As it relates to our readiness and getting moving, we've established home use pricing for veterans that are receiving their care through the United States Veterans Affairs System. We have the product on the federal supply schedule, so it is available today. For other home users, we have cash pay and third-party financing options. But we also know that ultimately we'll need payer support here to make this therapy as broadly available as everybody in the community and we would like. So, to help both patients and our clinic partners with that, we're going to be implementing patient access programs to support everything from prior authorizations to claim submissions to, if needed, appeals for claim denials. Development of those programs is currently underway. And we look forward to putting them in place in the first half of 2026. On the logistical flows on how a person goes about getting a system, you can see that on the slide. Onward is going to partner with clinics to provide all of that setup and support. So as Archie X is only available by prescription only, it means that the start of the journey for a person that wants to get access to Archie X in the home is the start of the journey is for them to visit their clinic to assess whether or not the therapy is right for them to obtain a prescription. Once there is a prescription that prescription sent to Onward Onward works with its accredited third party partner to complete the prescription verification and billing. And upon payment, the device is shipped directly to the person's home. The person then will take that device to their clinic for setup, for programming, and for training. That training will be both for them and for any caregivers that they have that support them. And then ongoing support after that point is done in two ways. The primary piece of support will be done by the clinic itself, and Onward has a team of therapy consultants and clinical managers distributed around the United States to help support the clinics in caring for their clients. Beyond that, we'll also have support through the Onward Customer Experience team, helping with things like logistics and troubleshooting. And we'll have a bunch of training resources, whether video prints and all of those types of things, on the website to help with the most common questions and the challenges, potential challenges in any of those early stages of use. So we're obviously very excited about these new growth catalysts. We've been working on readiness for many months. We're looking forward to being able to bring the new therapy to people living with SCI in Europe, and then also bringing this therapy into the home, allowing people living with SCI to extend the benefits that they're seeing with RDX in the clinic into the home setting. Enthusiasm is very high for the product.

All right. Thank you so much, Sean. Let me now move on to some of the other achievements this quarter. Starting with our capital raise, so we raised over 50 million euros in new equity capital, extending our cash runway into Q1 2027. This was a very clean financing supported by demand from high-quality long-only and sector specialist investors. Our anchor investors were Ottobock, Invis, and ASR's Global Impact Equity Fund. So we had a strategic, a specialist investor, and a well-respected generalist investor. This is the second time Ottobock has anchored an investment for us, and we really continue to value that partnership very highly. Moving on, we also received UL mark certification, reinforcing the engineering and process integrity underlying the Archaic system. UL, for those of you who don't know, certifies that Onward meets rigorous standards required by UL solutions across design documentation, certifications, component traceability, and safety test reports. This opens the door to certain U.S. clinics and hospitals that have a strict requirement for a nationally recognized testing laboratory mark. So, for example, the biomedical engineering departments in certain clinics or hospitals will not permit the purchase and deployment of a piece of medical hardware without this UL certification, so we're pleased to have this now in place. We continued our legacy of outstanding scientific publications in the third quarter. There were concurrent nature and nature medicine publications detailing the blood pressure feasibility study results and the underlying mechanism. So our thanks and congratulations to Professor Cortine and colleagues for those breakthroughs. There was also a publication on the lift home study results published in Neurology Clinical Practice. So more on that. That was a study we did to – It's part of our data package for FDA to get the home use 510K. There were five sites, 17 participants, looking at the safety, usability, and therapeutic benefits of at-home ArcheX therapy as a continuation of in-clinic treatment. So 96% of the sessions that were attempted were successfully completed. Compliance was high. We observed that the home use maintained or further enhanced the benefits following in-clinic use and 65%, so about two-thirds of participants showed clinically meaningful improvements in at least one primary strength or function assessment during the study. And as is always important, there were no serious device-related adverse events. As far as EmpowerBP is concerned, and again, we did get IDE approval from FDA to start EmpowerBP, We have our first site activated, and that is Craig Hospital in Denver, Colorado. This is one of the world's preeminent rehabilitation clinics, and we expect additional site activations to follow this in rather short order, and we further expect to announce first participant enrollment before the end of the year. We continue to strengthen the leadership of the company. In fact, this is the next wave of leaders that we need to scale the company. I'm very pleased with it. group of people who've chosen to work here and commit to our mission. You heard from Sean Shara, a very impressive guy, very pleased to have him here. He initially joined us as VP Marketing, and we recently promoted him to Chief Commercial Officer. Sean is a longtime leader at Boston Scientific and Integer. He's launched scores of products, and again, we're very pleased that he's bringing his experience to bear at Onward. We also... I've hired a new chief financial officer who will be starting in early January, Ali Kiboro. Ali was CFO at AliveDX and a senior finance leader at Quest Diagnostics. He has more than 25 years of finance leadership, including service as a NASDAQ CFO. He's very well educated. He has an MBA from the Wharton School at University of Pennsylvania. and very pleased to have him join us, and you'll be hearing a lot from Ali starting next year. And then starting December 1st, we have another high-powered senior leader, that being Sherry O'Quinn, who will be joining us as Chief Clinical Regulatory and Quality Officer. She's been a longtime leader in those disciplines at W.L. Gore, C.R. Bard, Trivascular and Endologic, so therefore startup experience as well as Big company experience. She has experience as well with both Class 2 and Class 3 devices, innovative therapies, and healthcare economics. And we're confident she's going to add a lot to the company as well. And you'll be hearing from her as early as December, but more likely next year. All right. So next to comment on our Q3 financial results is our Senior Finance Director, Amori Frazier. Amori. Amori.

Thank you, Dave. So as you have heard earlier on the call, we recorded 1.7 million in revenue for this quarter, reflecting continued execution of our early commercial activities. Our cash burn for Q3 was 8 million euros, driven by ongoing investments in commercialization, R&D, and preparation for pivotal clinical milestones. We ended the quarter with 32.9 million euros in net cash as of the end of September, And following the October capital raise, our net cash position increased to 77.7 million at the end of October. This provides us with a strengthened balance sheet and supports our ongoing focus on disciplined capital management. Overall, with increased liquidity and ongoing operational focus, we are well positioned to execute on our near-term priorities. Back to you, Dave.

Thank you, Maury. Okay, now on to our outlook. So, putting up slide 23 here on milestones and news flow. And you can see we've knocked out quite a few of these this year. There are some remaining, and some may also occur in the first quarter of next year. But we continue to expect to announce first participant enrollment in the EmpowerBP Pivotal Study, also first commercial sale. in Europe for ARC-EX. Both of those are expected later this year. First in human use of ARC-IM for bladder could happen in fourth quarter or first quarter, and then first implant of ARC-BCI for stroke is also something that we expect in the coming months. We're likely to refresh this slide as we go into next year, but it's satisfying to see all of these milestones completed, which is really a credit to the Very committed and hardworking team here at Onward Medical. So with that, Sharon, let's go ahead and open up the lines for questions, starting with the analysts. I think they have to press star 1-1, if I'm not mistaken.

Thank you, sir. As a reminder, to ask a question, you will need to press star 1-1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1-1 again. If you wish to ask a question via the webcast, please type it into the box and click submit. I will hand back to you, Dave.

Thank you. So, while we're waiting for that queue, there are a couple of questions that came in via the chat. One of them from Mr. English, wanting to know about pricing for Archie X in the US and Europe, clinics and home. So the pricing is more or less the same for U.S. and Europe, allowing for differences in foreign exchange. We do intend, as Sean Shara indicated earlier in the call, that we do intend to price the home use device about 25% lower than the clinic use device. A couple of reasons for that. One is we're a mission-driven company. Access is very important to us. So we want to make sure that this device and the therapy is available to as many people as possible. And also it's a more limited device in terms of feature set than the clinic use device. All right. It looks like we've got a few questions, but I'm not seeing them, Sharon. So why don't you take them?

Thank you, sir. Your first question comes from the line of Ed Hall from Siebel. Please go ahead.

Thank you very much. Good afternoon, all. A couple of questions from my side. I think, firstly, just on the backlog of leads, could you talk about this from, obviously, firstly, from the clinic and the home use perspective? And if we think about looking to next year and collating leads into sales, how is this going to be, how is this going to work? Are we going to see those already in the clinic prioritized? That would be my first question. Second question would just be on your your outlook based on the data you've seen from revenues this year as a percentage of sort of RKX devices that are put on rental versus outright purchased. That would be great. And then I have a follow-up after that.

All right, Ed. I love your compound questions. I'll do my best to keep track here. So we're unlikely to pursue a lot of direct-to-patient services. at least in the next several quarters, because we think it's going to be more efficient and effective to go through clinics. And we want people with spinal cord injury to first experience the therapy in the clinic. That way their programming parameters can be optimized. They can be trained on using the device. Their caregiver can be trained on using the device. And then they can be prescribed use of the device for use at home. And also, as Sean indicated earlier in the call, we part of our deployment case is that home use devices are paired with clinic devices and in a very efficient way with a QR code, the programming parameters can be ported over to the home use device. So for those reasons, the way we're viewing the queue or the lineup for home use sales is that we're expecting that most of the home use sales will come from those patients who have already or will experience use of the device in the clinic environment. Secondly, as for next year, as you know, we don't issue guidance at this stage of the company. However, the consensus is that we'll do low to mid teens. in revenue from a Euro perspective, which would be mid to high teens from a dollar perspective. And that would constitute more than doubling and even perhaps tripling of revenue year over year. So we would consider that a big success. And that would be in line with year two of some of the more successful med tech companies that have emerged over the past decade or so. I think I might have forgotten your third question, Ed.

It was just on maybe just looking at this year as a percentage of rental cases versus outright purchase.

Yeah, we haven't really broken that down, at least not at this time, but the vast majority of them are purchases.

Yeah, perfect. And then finally, just quickly on, you talk about Empower BP and the enrollment there. We've seen the first site activated in Colorado. Can we just unpack how quickly do you expect enrollment, especially for this indication? You've talked about the broad interest in Archie X, and I don't know how you could potentially draw comparisons to the therapy for the clinical trial and how quickly we could see full enrollment.

Yeah, we're hopeful that enrollment will go quickly. There's a lot of interest and excitement about the blood pressure instability therapy in the community, and the centers with whom we've been having discussions about participation and startup have been identifying potential study participants. So, it could go relatively quickly. I don't want to necessarily, again, guide on when the thing is going to fully enroll, but we're hopeful that we can get to the point of interim analysis by late summer. So if you recall, again, one of the benefits of having 10 breakthrough device designations is we have frequent interaction with FDA. Such was the case with EmpowerVP. We do have an interim analysis built into the study where we can pause at 33 participants and look at efficacy at that point. Should that go well, we can stop the study at 33 for efficacy and I believe 60 for safety, and that would lead to a more favorable launch date. As far as full enrollment, again, I'd like to maybe defer comment on that until we get started on the study and I have more information.

Perfect. Thank you very much.

Thank you. Your next question comes from the line of Jacob McHale from KBC Securities. Please go ahead.

Hi there, and thanks for taking my question. I have one maybe a follow-up on the home use, you know, purchases. From the patients that are currently being treated in the clinic, do you have an idea in terms of demand that those patients would have towards buying the device? And maybe can you quantify what proportion of those patients would be able to or would have the means to buy the device or would be able to get reimbursed for home use?

Yeah, thank you, Jacob. So, demand is quite high. We're getting a lot of inbound interest from patients about home use. The one caution I would have is that not everyone has reimbursement coverage from day one, and here we're talking about the United States. So, at this point in time, we think the most likely purchasers, those that have potential reimbursement, will come from the military hospital system, so the VA. Also, those covered by workers' compensation insurance, they can all purchase a device without a code. We also expect some demand in the near term from those who have the means to self-pay, so to buy it themselves. And then, as Sean mentioned, we're going to stand up a patient access program to support the pursuit of reimbursement from private payers on a case-by-case basis. So, that's how we're going to drive growth over the next couple of years. The VA, workers' comp, self-pay. and private pay on a case-by-case basis, as well as any sales that come from the EU and other geographies, high-profile geographies that accept FDA approval or CE mark. We're intentionally not pursuing a code, a Medicare code at the beginning because we want at the right time and with the right evidence, lock in a favorable code and favorable coverage. So, we may not have that for three years. But in the meantime, we have ample growth opportunities in front of us and certainly enough of an opportunity to sustain the sort of growth that is expected by the consensus.

Okay, thanks. And maybe just a follow-up on the reimbursement by the VA. Could you perhaps walk us through how this process would work in practice? And what criteria do they need in order to reimburse the RKX device? And maybe a follow-up on that, would this also apply to RKIM further down the line?

Yeah, so first I'm going to clear off the RKIM question, and then I'm going to turn it over to Shanshara, who, by the way, is a fourth-generation military veteran, and he can comment on the VA. As far as RKIM, that has more established reimbursement pathways. in fact, globally, because there are codes that exist for the implantation of neurostimulators and spinal cord leads. And then we believe we'll be eligible for new technology add-on payments and pass-through payments that are in place to support novel technology such as this. There's also an initiative underway in the U.S. where there's a group of neurotechnology companies that are not pursuing pain and they're pursuing a higher paying code, and that's something that we can get involved with at the appropriate time. We do have some time to sort that out, given that we don't expect Arc IM to be approved in the U.S. until 2028. Now, as far as how the VA works, it's a bit more complex, and I usually wouldn't take it on a call like this, but I think Sean can explain it pretty simply for the group. Sean, do you want to just handle clinic and home purchase processes within the VA?

Absolutely, Dave. Thank you. The purchase process for a clinic unit would look very similar to the purchase process for any other clinic. So it's a piece of capital equipment that gets purchased under capital budgeting processes. Where the VA will be a little bit different is in the home use setting. So the VA, unlike other clinics, reimbursement kind of services or programs kind of in the United States, either public or private, where a service is performed and then it's reimbursed or the piece of equipment is reimbursed. The VA is a cost-based system, not a reimbursement-based system. So they have an appropriation and a budget that they get from the government and they can spend that kind of as they see fit in different places. So under those auspices with the product being approved, it is eligible now to be purchased for veterans for use in the home. So the work that we'll be doing here in the coming quarters is working with all of the local VAs to establish the appropriate workflows for veterans who are coming in as part of their annual, veterans with SCI that come in as part of their annual check-ins to evaluate them for suitability of the ARC-EX product in the home. And at that point, they could be purchased for the veteran in the home.

Thank you, Sean. Sharon, let's go to David, and then I think we can convert over to the chat.

Thank you. David, your line is now open.

Hey, good afternoon. Congratulations on the commercial progress and leadership additions. Very impressive profiles there. Can you maybe talk a little bit about the clinic mix and the device utilization rates in the U.S. centers you've sold to so far? Like, are they fully occupied throughout the week, or do you have a few centers with just one or more patients coming in per week? This will be obviously crucial to drive home use next year. I'm going forward. Thank you.

Sure, David. Sean, do you want to take that one as well?

And I'm sorry, I cut out just for a second there, David.

Yeah, I think David was just asking about the utilization of the devices that are in clinics now. Are they being used all day? Are there wait lists? Is there demand for more than one device at certain clinics? He just wants to get a sense for that.

Yeah, absolutely. Utilization is high. Devices are used typically four to five days a week, anywhere from five to eight hours a day. So as the word gets out, and we saw some of the social media that we shared in that video where clinics are using RKEX to promote some of the additional capabilities and technologies that they have to offer to their clients. It's bringing more demand in and we are seeing a dramatic increase here really over the last quarter of customers coming to us and wanting to talk about the addition of a second unit. And then as we get into a lot more of our kind of purchasing discussions, a lot of these initial discussions center around multiple units right out of the gate as some of the enthusiasm and excitement about the product is getting out. So utilization is high. And the other thing that's probably worth stating in there is we do monitor it on an ongoing basis. And what we see is it remains high. So it's not something that starts with a big bang and then tails off. It starts high and stays high from a utilization perspective.

Okay. And perhaps just the first part, right, the clinic mix. I remember initially you set out this Tier 1 list of, I think, 75 clinics in the U.S. I think last call you mentioned as well that some community centers are buying the device. So just curious how many of these 75 Tier 1 clinics you have ticked off so far.

Yeah, why don't I take that one, Sean? So that's not a number that we've necessarily given. What I will say is this, David, there were 25 SCI hub centers within the VA system embedded in the 75, and as I've shared with you in the past, the VA uptake has been slow this year owing to the uncertainty and some of the instability with U.S. government spending and staffing and so forth. We are now seeing that roar back, and the VA is normalizing. So I think in the fourth quarter and in the first quarter of next year, we look forward to making some very positive announcements about VA penetration, which will put us in really excellent shape in terms of penetration of those first 75. Okay. Thank you. All right. Okay. So now let's go over to the chat, and our newest equity research analyst, Clément from BNP. There are a couple of questions from you, Clément. Perhaps you don't know, but he initiated coverage last quarter, our first French-language coverage, for those of you who are more comfortable en français. He has two questions here. Okay, Sean, maybe this is for you. What are we viewing in terms of backlog for ArcheX in clinics? and about the opportunity to sell multiple devices to clinics. You spoke to this a bit earlier, but maybe you can tease fourth quarter and some of the maybe new things that folks can look forward to.

Yeah, I would say our sales pipeline is incredibly robust. And what we're working through for the most part with our clinic customers is just working through their capital budgeting cycles kind of around timelines. So deep pipeline that I think has us feeling very bullish about our ability to continue to grow and penetrate clinics. And the variable piece that we're working with is just the capital budgeting cycles there. And the question about multiple units, we have many in the pipeline that are multiple deal purchases. And as we're starting to get kind of deeper into the sales pipeline and some of these larger centers, as you were referring to, Dave, with the Tier 1 centers, a lot of those centers, now that they're seeing some of the momentum that's out there about ArcheX, are the ones that are talking to us about more than one unit, just understanding that they've got larger patient pools. They have kind of more complicated patient flows in terms of how they do scheduling and moving people through and just acknowledging that they may need more than one unit.

Perfect. And Clément also asks Sean how the home device is paired with a clinic device and whether he should consider the clinic device a master that manages multiple home use ArcheX devices or whether the home device is just a just links to software that's hosted at the clinic? Just a bit more detail on that.

Yes, you can think of them in many ways as tethered. So the unit we call the professional unit, which is the one in the clinic, is a system that's designed for a clinic to manage many patients with many different stimulation parameters and programs, all from one central unit. And then the home use unit is a little bit de-featured in that it just allows one stimulation program to be used for one very specific person. And the way that that is transitioned is all of the work is done in the clinic to understand how to set up the device and set up these very specific stimulation parameters that are optimized to that patient and to the rehabilitation program that's been established for the goals that they're trying to reach. And then that program is the one that is transitioned onto the personal unit. And then the personal unit, you know, at home has very limited ability to change parameters at all. So that's obviously a safety feature and is designed to make sure that the home-based therapy stays aligned with the rehabilitation program that has been established by the healthcare professional in the clinic.

All right, thank you, Sean. Nicolas Nordin from Paris asks, hello, team. Congratulations on recent achievements. Can we get a quick reminder of the Arc IM upcoming catalysts and calendar? So there are two primary catalysts upcoming, Nicolas. One is first participant enrollment in the Uplift, sorry, the Empower BP study. So that's our pivotal study for Arc IM. where CRAIG is now activated as a site, and we hope to have first participant enrollment announced here before the end of the year. The other rather important milestone would be late next summer, when we hope to unblind the data and conduct an interim analysis of the first 33 participants in the study. And if things go extremely well, we may have the option to stop the study early, which would lead to an earlier approval, first half of 2028 versus second half of 2028. There may be some additional announcements of a clinical feasibility study in the area of mobility and also some additional announcements with Arc IM paired with a brain-computer interface to enable thought-driven movement restoration. All of those can be reasonably expected in the coming months. All right. see, we have a couple of other questions. One is just on OPEX. Why is OPEX increasing? So OPEX is pretty flat this year. As Amori said, it was a bit down in Q, or at least the cash burn. Let's just focus on cash burn. Cash burn was a bit down in Q3, but that can be attributed more to the timing of project and payables versus anything else. We think that the The cash burn will be fairly steady this year at around 9.5 to 10 million euros per quarter. We do also expect that to grow next year because we are both commercializing ArcheX and spending on the conduct of the Empower BP clinical study. However, we are continuing to approach things with a lot of focus and capital discipline. And as mentioned, we have runway into Q1 of 2027, and that's without taking down any more of our debt facility with runway growth partners. So we do have flexibility and optionality in our capital structure, but we're going to keep our heads down and keep doing a really cautious job of managing our capital as we've done in the past. Okay. I don't think we have any other questions unless you flip over to the other screen, Seb, and somebody else has come in telephonically. Nope. Okay. Anyway, thanks, everyone, for joining. Really appreciate your time and attention. Thank you, Amori and Sean, for your support today. And we look forward to delivering another excellent quarter in the fourth quarter. And we'll talk to you soon.