Half Year 2026 ONWARD Medical NV Earnings Call

September 9, 2026

Operator: Good day and thank you for standing by. Welcome to the ONWARD Medical H1 2026 results webcast. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Alternatively, you may submit your question via the webcast. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sébastien Cros, Head of Communications. Please go ahead.

Speaker #1: Good day, and thank you for standing by. Welcome to the ONWARD Medical first half 2026 results webcast. At this time, all participants are in a listen-only mode.

Speaker #1: After the speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone.

Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and then 1 again. Alternatively, you may submit your question via the webcast.

Operator: You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Alternatively, you may submit your question via the webcast. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sébastien Cros, Head of Communications. Please go ahead.

Speaker #1: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Sebastian Cross, Head of Communications.

Speaker #1: Please go ahead.

Speaker #2: Thank you, Mel. Good morning, good afternoon, everyone, and welcome to ONWARD's webcast following our results for the first half of 2026. Before we get started, please take a moment to read the usual disclaimer.

Sébastien Cros: Thank you, Mel. Good morning, good afternoon, everyone, and welcome to ONWARD's webcast following our results for the H1 of 2026. Before we get started, please take a moment to read the usual disclaimer. This deck includes forward-looking statements which should be considered with the appropriate level of caution as outlined on this page. The deck and the recording of the webcast will be available on our investor platform after the call. Today for the call, I am joined with four members of ONWARD's leadership team, Dave, our CEO, Ali, CFO, Shari, our Chief Clinical, Regulatory, and Quality Officer, and Sean, our Chief Commercial Officer. We will start by covering the results and key highlights from the H1 of the year before opening the floor for questions. You may submit your questions orally or via the Q&A module on the platform. With that, I will hand over to Dave.

Speaker #2: This deck includes forward-looking statements, which should be considered with the appropriate level of caution, as outlined on this page. The deck and the recording of the webcast will be available on our investor platform after the call.

Speaker #2: Today, for the call, I'm joined by four members of ONWARD's leadership team: Dave, our CEO; Ali, CFO; Sherry, our Chief Clinical, Regulatory, and Quality Officer; and Sean, our Chief Commercial Officer.

Sébastien Cros: Today for the call, I am joined with four members of ONWARD's leadership team, Dave, our CEO, Ali, CFO, Shari, our Chief Clinical, Regulatory, and Quality Officer, and Sean, our Chief Commercial Officer. We will start by covering the results and key highlights from the H1 of the year before opening the floor for questions. You may submit your questions orally or via the Q&A module on the platform. With that, I will hand over to Dave.

Speaker #2: We'll start by covering the results and key highlights from the first half of the year. Before opening the floor for questions, you may submit your questions orally or via the Q&A module on the platform.

Speaker #2: With that, I'll hand over to Dave.

Speaker #3: Thank you, Seb. I have an easy job today because I've got my leadership team carrying most of the weight. Thank you, everyone, for joining.

Dave Marver: Thank you, Seb. I have an easy job today because I have got my leadership team carrying most of the weight. Thank you everyone for joining. Let me start with the highlights. Very strong quarter again. 159 RTX systems were sold or supplied via paid evaluation in the H1 of 2026. That is more than a 5X increase year over year. ARC-EX systems were available in over 130 US clinics and 150 clinics worldwide in the H1. We also achieved implants in the ARC-IM pivotal trial, called Empower BP, to address blood pressure instability after spinal cord injury. 22 participants are enrolled in the study and 14 clinical sites are now active to date. That is all the sites in the US and Canada, and Europe is next. We initiated the EIGER feasibility study for ARC-IM mobility. This is an important study.

Speaker #3: Let me start with the highlights. Very strong quarter again. 159 RTX systems were sold, or supplied via paid evaluation in the first half of 2026.

Speaker #3: That's more than a 5x increase year over year. RTX systems were available in over 130 U.S. clinics and 150 clinics worldwide. In the first half, we also achieved implants in the ARC-IM pivotal trial called Empower BP, to address blood pressure instability after spinal cord injury.

Dave Marver: We also achieved implants in the ARC-IM pivotal trial, called Empower BP, to address blood pressure instability after spinal cord injury. 22 participants are enrolled in the study and 14 clinical sites are now active to date. That is all the sites in the US and Canada, and Europe is next. We initiated the EIGER feasibility study for ARC-IM mobility. This is an important study.

Speaker #3: Twenty-two participants are enrolled in the study, and fourteen clinical sites are now active to date. So that's all the sites in the U.S. and Canada, and Europe is next.

Speaker #3: We initiated the IGER feasibility study for ARC-IM mobility. This is an important study. It's a precursor to an eventual pivotal study for this indication.

Dave Marver: It is a precursor to an eventual pivotal study for this indication. We successfully implanted an additional patient in the Parkinson's disease blood pressure trial, something called PD-HemON, and we announced two additional ARC-BCI implants, extending our global leadership in this realm. We reported EUR 4.2 million in revenue. That is a 250% year over year increase, and we ended the H1 with a cash balance of EUR 81.5 million. We raised over EUR 40 million in new equity capital, including a EUR 25 million investment from EQT Life Sciences, and we replaced our existing loan with an up to EUR 50 million debt facility from BlackRock. With that, I would like to turn it over to Sean, our Chief Commercial Officer. Take it away, Sean.

Speaker #3: We successfully implanted an additional patient in the Parkinson's disease blood pressure trial, something called PD-Hemon. And we announced two additional ARC-BCI implants, extending our global leadership in this realm.

Speaker #3: We reported €4.2 million in revenue. That's a 250% year-over-year increase. And we ended the first half with a cash balance of €81.5 million.

Speaker #3: We raised over 40 million in new equity capital including a 25 million euro investment from EQT Life Sciences. And we replaced our existing loan with an up to 50 million euro debt facility from BlackRock.

Dave Marver: We raised over EUR 40 million in new equity capital, including a EUR 25 million investment from EQT Life Sciences, and we replaced our existing loan with an up to EUR 50 million debt facility from BlackRock. With that, I would like to turn it over to Sean, our Chief Commercial Officer. Take it away, Sean.

Speaker #3: With that, I'd like to turn it over to Sean, our Chief Commercial Officer. Take it away, Sean.

Speaker #4: Yes, absolutely. Thanks, Dave. That's a great intro to follow, and I'm excited to be here today to talk with everyone about RTX, a product that is really starting to transform what is possible in rehabilitation for people living with spinal cord injury.

Sean Sciara: Yes, absolutely. Thanks, Dave. That's a great intro to follow, and I'm excited to be here today to talk to everyone about ARC-EX, a product that is really starting to transform what is possible in rehabilitation for people living with spinal cord injury. Q2 saw continued strong execution and uptake of the product. It continues the momentum that started with our commercial launch last year and has continued each quarter since. As Dave mentioned, in H1 2026, we had 159 systems, either sold or sold as part of a paid evaluation in the U.S. Department of Veterans Affairs healthcare system, and 89 of those sales happened in the second quarter. We delivered nearly as many ARC-EX units in the second quarter of this year as we did in all of 2025. I think that fact speaks to two things, really.

Speaker #4: Q2, I saw continued strong execution and uptake of the product. So it continues the momentum that started with our commercial launch last year and has continued each quarter since.

Speaker #4: As Dave mentioned, in the first half of 2026, we had 159 systems either sold or sold as part of a paid evaluation in the U.S.

Sean Sciara: As Dave mentioned, in H1 2026, we had 159 systems, either sold or sold as part of a paid evaluation in the U.S. Department of Veterans Affairs healthcare system, and 89 of those sales happened in the second quarter. We delivered nearly as many ARC-EX units in the second quarter of this year as we did in all of 2025. I think that fact speaks to two things, really.

Speaker #4: Veteran Affairs Healthcare System. And 89 of those sales happened in the second quarter. So we delivered nearly as many RTX units in the second quarter of this year as we did in all of 2025.

Speaker #4: And I think that fact speaks to two things, really. The first is the value that healthcare providers and people living with spinal cord injury see in the technology.

Sean Sciara: The first is the value of the system that healthcare providers and people living with spinal cord injury see in the technology. Second, it also speaks to ONWARD's ability to aggressively ramp the commercial capabilities required to execute and scale. That's across all the functional areas, whether it's sales and marketing and customer service or operations and finance and quality. In parallel with this product launch, we're also building a sustainable commercial engine for the company moving forward. At the end of Q2, as Dave mentioned, ARC-EX is present in over 150 clinics around the globe. Over 130 of those are in the United States. After six quarters of selling in the U.S., we estimate our footprint to be 35% to 40% of the facilities that manage people living with spinal cord injury.

Speaker #4: And second, it also speaks to ONWARD's ability to aggressively ramp the commercial capabilities required to execute and scale. And that's across all the functional areas, whether it's sales and marketing, customer service, operations, finance, or quality.

Speaker #4: So in parallel, with this product launch, we're also building a sustainable commercial engine for the company moving forward. At the end of Q2, as Dave mentioned, RTX's presence in over 150 clinics around the globe, over 130 of those are in the United States.

Speaker #4: So after six quarters of selling in the U.S., we estimate our footprint to be 35% to 40% of the facilities that manage people living with spinal cord injury.

Speaker #4: This is tremendous progress, I think, for a brand-new therapy in such a short period of time. Our commercial efforts in the VA have really started to accelerate.

Sean Sciara: This is tremendous progress, I think, for a brand new therapy in such a short period of time. Our commercial efforts in the VA have really started to accelerate. We started our selling into the VA in earnest with the availability of the home-use version of ARC-EX earlier this year, and in two focused quarters of selling in the VA, we're now in half of the hub facilities that focus on spinal cord injury therapy and treatments for veterans. We were also pleased to see that the VA National Program Office issued guidelines in July for transcutaneous spinal cord stimulation.

Speaker #4: We started our selling into the VA in earnest with the availability of the home-use version of RTX earlier this year. And in two focused quarters of selling in the VA, we're now in half of the hub facilities that focus on spinal cord injury therapy and treatments for veterans.

Speaker #4: We're also pleased to see that the VA National Program Office issued guidelines in July for transcutaneous spinal cord stimulation. These guidelines are a positive sign of adoption for the new therapy.

Sean Sciara: These guidelines are a positive sign of adoption for the new therapy, and while they're not a requirement, they're guidelines, not a requirement for the facilities, enough VA clinics were starting to use the device that the VA clearly saw the need to issue some guidance, and overall, that guidance is fairly favorable for transcutaneous spinal cord stimulation. We see that as a nice vote of confidence for a young therapy in the VA. In Europe, we had our first sales into Europe at the end of 2025, and since then, through H1 2026, we've seen sales into seven different countries and a growing clinic footprint that we are achieving and supporting through a combination of direct sales and distribution partners.

Speaker #4: And while they're not a requirement—they're guidelines, not a requirement—for the facilities, enough VA clinics were starting to use the device that the VA clearly saw the need to issue some guidance.

Speaker #4: And overall, that guidance is fairly favorable for transcutaneous spinal cord stimulation. So we see that as a nice vote of confidence for a young therapy in the VA.

Speaker #4: In Europe, we had our first sales into Europe at the end of 2025. Since then, through the first half of 2026, we've seen sales into seven different countries.

Speaker #4: And a growing clinic footprint that we are achieving and supporting through a combination of direct sales and distribution partners. So, while we're still really early in the commercialization of this therapy, the base of real-world use is starting to become quite large.

Sean Sciara: While we are still really early in the commercialization of this therapy, the base of real-world use is starting to become quite large and growing quickly every day. We are really excited about what we are seeing in that real-world usage. At this point, there have been tens of thousands of ARC-EX sessions performed across more than 100 centers in multiple countries with hundreds of different operators and therapists. We are starting to see that the results can be replicated across all those different environments. The treatment is also starting to move towards the mainstream, especially in the United States, where it has been on the market a little bit longer. What we are starting to see in that real-world use also gives us confidence in how the product performs, but also gives us confidence that the results that we are seeing in clinical trials can also be seen in real-world use.

Speaker #4: And growing quickly every day. And we're really excited about what we're seeing in that real-world usage. So at this point, there have been tens of thousands of RTX sessions performed across more than 100 centers in multiple countries with hundreds of different operators and therapists.

Speaker #4: And we're starting to see that the results can be replicated across all those different environments. The treatments also starting to move towards the mainstream.

Sean Sciara: We are starting to see that the results can be replicated across all those different environments. The treatment is also starting to move towards the mainstream, especially in the United States, where it has been on the market a little bit longer. What we are starting to see in that real-world use also gives us confidence in how the product performs, but also gives us confidence that the results that we are seeing in clinical trials can also be seen in real-world use.

Speaker #4: Especially in the United States, where it's been on the market a little bit longer. What we're starting to see in that real-world use also gives us confidence in how the product performs.

Speaker #4: But it also gives us confidence that the results we're seeing in clinical trials can also be seen in real-world use. So, our RTX—it's not unfair to say that the RTX is truly having a profound impact on spinal cord injury rehabilitation.

Sean Sciara: ARC-EX, it is not unfair to say that the ARC-EX is truly having a profound impact on spinal cord injury rehabilitation. We expect that to continue to grow as the time in the market grows and as more people have the opportunity to experience it. To underscore that, I thought we could share a short video here today from one of the key rehabilitation centers in the United States. In this video, you will hear from Dr. David Putrino. Dr. Putrino is the Director of Rehabilitation Innovation for the Mount Sinai Health System in New York.

Speaker #4: We expect that to continue to grow as the time in the market grows and as more people have the opportunity to experience it. To underscore that, I thought we could share a short video here today from one of the key rehabilitation centers in the United States.

Speaker #4: So in this video, you'll hear from Dr. David Petrino. Dr. Petrino is the Director of Rehabilitation Innovation for the Mount Sinai Health System in New York.

Speaker #4: So Seb, if we could play that video and hear from Dr. Petrino.

Dave Marver: Seb, if we could play that video and hear from Dr. Putrino.

Speaker #2: The patient impact is immeasurable. We have had people able to use their upper extremity after being told, again, that they would never recover some of the function that they had lost.

David Putrino: The patient impact is immeasurable. We have had people able to use their upper extremity after being told, again, that they would never recover some of the function that they had lost. My name is David Putrino. I am the Director of Rehabilitation Innovation for the Mount Sinai Health System. I started out clinically as a physical therapist in Australia, and then I completed a PhD in neuroscience, where I was really focused on trying to understand how the brain regains control of movement after injury, and after just general age-related changes. Anatomy is not destiny. We often get told, "Oh, look at this brain injury. You are never going to recover. Look at this spinal cord injury. You are going to be a wheelchair user for the rest of your life." We have learned over and over again that anatomy is not destiny.

Speaker #2: My name is David Petrino. I am the Director of Rehabilitation Innovation for the Mount Sinai Health System. I started out clinically as a physical therapist.

Speaker #2: In Australia. And then I completed a PhD in neuroscience, where I was really focused on trying to understand how the brain regains control of movement after injury and after general age-related changes.

Speaker #2: Anatomy is not destiny. We often get told, "Oh, look at this brain injury. You're never going to recover. Look at this spinal cord injury."

Speaker #2: "You're going to be a wheelchair user for the rest of your life." We have learned over and over again that anatomy isn't destiny. I feel that we're at a truly exciting point in what's available to patients in neurotechnology right now.

David Putrino: I feel that we're at a really, truly exciting point in what's available to patients in neurotechnology right now. The advent of both non-invasive and invasive neurostimulation strategies, so ways that we can stimulate the nervous system through haptics and transcutaneous spinal cord stimulation, as well as ways that we're getting into the body and being able to stimulate specific nerves or specific nerve roots. We've never seen that before, and we're starting to see outcomes in rehab that have never been seen before. The patient impact is immeasurable. We have had people relearning all sorts of new skills that they thought were lost forever.

Speaker #2: Sort of the advent of both non-invasive and invasive neurostimulation strategies—so ways that we can stimulate the nervous system through haptics and transcutaneous stimulation, as well as ways that we're getting into the body and being able to stimulate specific nerves or specific nerve roots. We've never seen that before, and we're starting to see outcomes in rehab that have never been seen before.

Speaker #2: The patient impact is immeasurable. We have had people relearning all sorts of new skills that they thought were lost forever.

Speaker #3: With that, maybe Sherry? Let's cover RKM.

Sébastien Cros: With that, maybe Sherri, let's cover ARC-IM.

Speaker #1: Okay. Oh, excellent. Thanks, Seb. So today, I'm excited to share an update on the progress that we've made on advancing our clinical work on the RKM platform.

Shari O'Quinn: Okay. Excellent. Thanks, Seb. Today, I'm excited to share an update on the progress that we've made on advancing our clinical work on the ARC-IM platform. I'll start with giving you some insights on our progress on the Empower BP global pivotal study. This is a study that's designed to address blood pressure instability after spinal cord injury. There's a significant unmet clinical need for this therapy, because over 90% of people with spinal cord injury who are treated with conventional therapies continue to experience symptoms. We announced earlier this year that we successfully implanted the first participant in Empower BP. There are over 22 participants enrolled in this study, and 14 additional clinical sites have been activated, and we expect additional sites in Europe to be activated in the next couple of months. Some sites in the study have already enrolled multiple participants.

Speaker #1: And I'll start with giving you some insights on our progress on the Empowered BP global pivotal study. And this is a study that's designed to address blood pressure instability after spinal cord injury.

Speaker #1: And there's a significant unmet clinical need for this therapy. Because over 90% of people with spinal cord injury were treated with conventional therapies continue to experience symptoms.

Speaker #1: And we announced earlier this year that we successfully implanted the first participant in Empowered BP. Now, there are over 22 participants enrolled in this study.

Speaker #1: And 14 additional or 14 additional clinical sites have been activated. And we expect additional sites in Europe to be activated in the next couple of months.

Speaker #1: And some sites in the study have already enrolled multiple participants. And some of the things that we're hearing from our sites and participants in the study is that RKM provides hope for people who've been told that blood pressure instability is an expected consequence of their injury.

Shari O'Quinn: Some of the things that we're hearing from our sites and participants in the study is that ARC-IM provides hope for people who've been told that blood pressure instability is an expected consequence of their injury. Many of the participants in the study say that they want to be in this study because the impact that blood pressure instability has on their daily lives. What that looks like is that they must sit in a reclined position when moving in their wheelchair. They may pass out just transferring from their bed to their chair in the mornings. Others who can't sit upright through an entire meal with their family and friends. These are just a few of the examples of why it's so important to us to find a treatment for this unmet clinical need.

Speaker #1: And many of the participants in the study say that they want to be in this study because of the impact that blood pressure instability has on their daily lives.

Speaker #1: And what that looks like is that they must sit in a reclined position when moving in their wheelchair. They may pass out just transferring from their bed to their chair in the mornings.

Speaker #1: And others who can't sit upright through an entire meal with their family and friends. And these are just a few of the examples of why it's so important to us to find a treatment for this unmet clinical need.

Speaker #1: And with that strong momentum that's building in Empowered BP, we expect that by the end of this year, we'll enroll the sample size that's needed for our interim analysis, which will be conducted early next year.

Shari O'Quinn: And with that strong momentum that is building in Empower BP, we expect that by the end of this year, we will enroll the sample size that is needed for our interim analysis that will be conducted early next year. We are also on track for regulatory approval by the end of 2028, with a commercial launch planned early 2029. We are also continuing to advance our pipeline. We completed the first successful implant in the EIGER feasibility clinical study, and that study is designed to demonstrate the ability for the ARC-IM to restore mobility in both sub-acute and chronic spinal cord injury population. This is a major step towards the pivotal study for this indication. This study will enroll up to 12 participants. We are advancing this study with grant funding that is being conducted at prominent institutions in Switzerland.

Speaker #1: We're also on track for regulatory approval by the end of 2028 with commercial launch planned early 2029. And we're also continuing to advance our pipeline.

Speaker #1: We completed the first successful implant in the Eiger feasibility clinical study. That study is designed to demonstrate the ability for the RKM to restore mobility in both subacute and chronic spinal cord injury populations.

Speaker #1: And this is a major step toward the pivotal study for this indication. And this study will enroll up to 12 participants. And we're advancing this study with grant funding that's being conducted at prominent institutions in Switzerland.

Speaker #1: And we've also successfully implanted additional patients in Parkinson's disease for blood pressure, and two additional patients in the ARC-BCI implant study for mobility.

Shari O'Quinn: We have also successfully implanted an additional patient in Parkinson's disease for blood pressure and two additional patients in the ARC-BCI implant study for mobility. This clinical progress demonstrates our ability to continue to expand indications for use for ARC-IM and advance all three ARC platforms towards solutions for these unmet clinical needs. With that, I will turn it back over to Dave.

Speaker #1: And this clinical progress demonstrates our ability to continue to expand indications for use for RKM and advance all three ARC platforms toward solutions for these unmet clinical needs.

Speaker #1: So, with that, I'll turn it back over to Dave.

Speaker #4: Thank you, Sherry. We also strengthened the balance sheet in the first half, successfully raising over $40 million in new equity capital to fuel our growth.

Dave Marver: Thank you, Sherri. We also strengthened the balance sheet in H1, successfully raising over EUR 40 million in new equity capital to fuel our growth. The financing included EUR 25 million from EQT Life Sciences. There was strong demand from existing and new high-quality loan-only and sector specialist investors, and our cash runway now extends into Q1 2028. We also replaced our existing loan with an up to EUR 50 million debt facility from BlackRock. BlackRock has replaced Runway Growth Capital as the company's lender. EUR 20 million was drawn at closing, and we have access to additional tranches as we grow Archiact's revenue and we advance toward commercialization of our investigational ARC-IM system. Additional tranches are tied to business milestones.

Speaker #4: The financing included $25 million from EQT Life Sciences. There was strong demand from existing and new high-quality long-only and sector specialist investors. And our cash runway now extends into Q1 2028.

Speaker #4: We also replaced our existing loan with an up to $50 million debt facility from BlackRock. So, BlackRock has replaced Runway Growth Capital as the company's lender.

Speaker #4: $20 million was drawn at closing. And we have access to additional tranches as we grow RKX revenue. And we advance toward commercialization of our investigational RKM system.

Speaker #4: So, additional tranches are tied to business milestones. And I just want to be clear that our existing loan facility with Runway Growth has been fully repaid and retired, using the $20 million tranche that we drew from BlackRock at closing.

Dave Marver: I just want to be clear that our existing loan facility with Runway Growth has been fully repaid and retired using the EUR 20 million tranche that we drew from BlackRock at closing. Only the BlackRock facility remains. All right. Now I would like to turn it over to Ali to review our H1 financial results in more detail.

Speaker #4: So, only the BlackRock facility remains. All right. Now, I'd like to turn it over to Ali to review our first half financial results in more detail.

Speaker #5: Thank you, Dave. Half-year revenues for 2026 were €4.2 million, €3.4 million of that was product revenues. Gross profit for the first half of the year was €2.9 million, or roughly 70%.

Ali Kiboro: Thank you, Dave. H1 revenues for 2026 was EUR 4.2 million, 3.4 million of that was product revenues. Gross profit for the H1 of the year was EUR 2.9 million, or roughly 70%. You will recall this is due to the mix between H1 of this year versus H1 of last year. H1 of last year, we were only selling professional units. H1 of this year, we are selling both professional and the home units. Total operating expenses is EUR 26.3 million, which is up from EUR 21 million last year. This is the continued investment we have in both our marketing and market access, as well as clinical and regulatory expenses over the course of this year as we commercialize ARC-EX and as we continue to execute on EmpowerBP implants and the sign-up of the sites.

Speaker #5: You will recall this is due to the mix between the first half of this year versus the first half of last year. In the first half of last year, we were only selling professional units.

Speaker #5: First half of this year, we are selling both professional and the home units. Total operating expenses is 26.3 million, which is up from 21 million euros last year.

Speaker #5: This is the continued investment. We have in both our marketing and market access as well as clinical and regulatory expenses over the course of this year as we commercialize RKX and as we continue to execute on Empowered BP implants and the sign-up of the sites.

Speaker #5: Overall, our operating losses for the first half is 23.3 million euros, which is in line with our expectations. Net loss for the period is 24.7 million euros.

Ali Kiboro: Overall, our operating losses for the H1 is EUR 23.3 million, which is in line with our expectations. Net loss for the period is EUR 24.7 million. Our cash position at the end of June 2026 is EUR 81.5 million. That is up from EUR 68.1 million at the start of the year. As Dave has mentioned, this is because we raised EUR 40.6 million in April. If we go to the next page, you will see that our cash burn for the H1 was EUR 26 million. As we've executed on our plan, we have EUR 81.5 million in cash as of the end of June 2026, which allows us to continue to execute on our priorities as a company. I'll turn this over back to Dave to take us through 2026.

Speaker #5: Our cash position at the end of June 2026 is €81.5 million. That is up from €68.1 million at the start of the year, as Dave has mentioned.

Speaker #5: This is because we raised €40.6 million in April. If we go to the next page, you will see that our cash burn for the first half was €26 million as we've executed on our plan.

Speaker #5: We have €81.5 million in cash as of the end of June 2026, which allows us to continue to execute on our priorities as a company.

Speaker #5: I'll turn this over back to Dave to take us through 2026.

Speaker #4: Thank you, Ali. So we're going to keep pushing here, and our priorities are scaling the commercialization of RKX and continuing to execute well on the conduct of the Empowered BP pivotal study.

Dave Marver: Thank you, Ali. We're going to keep pushing here, and our priorities are scaling the commercialization of ARC-EX and continuing to execute well on the conduct of the EmpowerBP pivotal study. But as usual, we expect continued and compelling news flow. This slide shows you the completed and upcoming milestones. Some of the things that we expect you can look forward to are first in human use of the ARC-IM system to address urinary incontinence. This is underactive bladder, which occurs after spinal cord injury. Also, very important moment that would be the top line interim readout from the EmpowerBP pivotal study. As Shari mentioned, we expect that next spring. And we expect to make continued progress in the realm of brain computer interface, both addressing movement deficits after spinal cord injury and stroke. A stroke is something that we're going to continue to explore.

Speaker #4: But as usual, we expect continued and compelling news flow. And so this slide shows you the completed and upcoming milestones, some of the things that we expect you can look forward to our first in human use of the RKM system to address urinary incontinence.

Speaker #4: This is underactive bladder, which occurs after spinal cord injury. Also, very important moment that would be the top line interim readout from the Empowered BP pivotal study.

Speaker #4: As Sherry mentioned, we expect that next spring, and we expect to make continued progress in the realm of brain-computer interface—both addressing movement deficits after spinal cord injury and stroke.

Speaker #4: Stroke is something that we're going to continue to explore. It's a large adjacent population. And we can leverage the R&D investments that we've already made.

Dave Marver: It's a large adjacent population, and we can leverage the R&D investments that we've already made. With that, thank you for your attention. And let's go to the questions in queue starting with Ed Hall, please.

Speaker #4: So with that, thank you for your attention. And let's go to the questions in Q, starting with Ed Hall, please.

Speaker #6: Hey, back to you, Mel. First, just to remind them how to.

Ali Kiboro: Back to you, Mel, first to remind them how to raise questions.

Sébastien Cros: Back to you, Mel, first to remind them how to raise questions.

Speaker #5: Great question.

Speaker #2: Thank you. As a reminder, to ask a question. You will need to press star one and one on your telephone and wait for your name to be announced to withdraw your question.

Operator: Thank you. As a reminder to ask a question, you will need to 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. If you wish to ask a question via the webcast, please type it into the box and click submit. We will now go to our first question. Our first question comes from the line of Edward Hall from Stifel. Please go ahead. Your line is open.

Speaker #2: Please press star one, and then one again. If you wish to ask a question via the webcast, please type it into the box and click Submit.

Speaker #2: We'll now go to our first question. And our first question comes from the line of Ed Hall from Stifel. Please go ahead. Your line is open.

Edward Hall: Thank you for taking my questions. I have a couple. The first one would be on the VA. I think you mentioned you are in 50% of the hubs, and it looks like you are penetrating quite nicely. I wonder if you could talk about the spoke penetration as well, if this is as relevant as the penetration into the hubs, and your expectations for the rest of the year for the VA. That would be my first question. Secondly, just on the potential for subacute patients. I would be curious to understand the rationale here. Is this to get a higher patient population overall, or is there an expectation of greater efficacy with this subacute patient population? Finally, just a bit of a housekeeping for me on the R&D spend in H1.

Ed Hall: Thank you for taking my questions. I have a couple. The first one would be on the VA. I think you mentioned you are in 50% of the hubs, and it looks like you are penetrating quite nicely. I wonder if you could talk about the spoke penetration as well, if this is as relevant as the penetration into the hubs, and your expectations for the rest of the year for the VA. That would be my first question. Secondly, just on the potential for subacute patients. I would be curious to understand the rationale here. Is this to get a higher patient population overall, or is there an expectation of greater efficacy with this subacute patient population? Finally, just a bit of a housekeeping for me on the R&D spend in H1.

Speaker #7: Thank you for taking my questions. I have a couple. The first one is on the VA. I think you mentioned you're in 50% of the hubs.

Speaker #7: And it looks like your penetrating quite nicely. I wonder if you could talk about the spoke penetration as well. If this is as relevant as the penetration into the hubs, and sort of your expectations for the rest of the year for the VA.

Speaker #7: That would be my first question. Secondly, just regarding the potential for subacute patients, I'd be curious to better understand the rationale here.

Speaker #7: Is this to get a higher patient population overall, or is there an expectation of greater efficacy with this subacute patient population? And then just finally, just a bit of housekeeping for me.

Speaker #7: On the R&D spend in H1, I mean, how much did you spend on Empowered BP so far in the year? Thank you.

Edward Hall: How much did you spend on Empower BP so far in the year? Thank you.

Ed Hall: How much did you spend on Empower BP so far in the year? Thank you.

Speaker #4: All right, thanks, Ed. So Sean, will you take the VA question first—the relative importance of spokes, and perhaps explain why we're in certain spokes and not solely in the hubs at this point?

Dave Marver: All right. Thanks, Ed. Sean, will you take the VA question first, the relative importance of spokes, and perhaps explain why we are in certain spokes and not solely in the hubs at this point?

Speaker #6: Yes, absolutely. Thanks, Dave. And thanks, Ed. So as we mentioned there on the in the prepared remarks, there are 25 SCI hubs in the VA.

Sean Sciara: Yes, absolutely. Thanks, Dave, and thanks, Ed. As we mentioned there in the prepared remarks, there are 25 SCI hubs in the VA. We are in half of them. We are also in four of the spokes. The spoke strategy is one that is highly dependent on whether or not the spoke actually does SCI care, or whether or not they refer their SCI patients to the hub, as well as the relationship between the hub and the spoke with respect to where the prescribing and decision-making is done. In a lot of regions around the country, all of that is centralized within the hub. The patients come there, or the hub makes the decision, and it is just administered at the spoke.

Speaker #6: We're in half of them. We're also in four of the spokes. The spoke strategy is one that's highly dependent on whether or not the spoke actually does SCI care, or whether or not they refer their SCI patients to the hub, as well as the relationship between the hub and the spoke with respect to where the prescribing and decision-making is done.

Speaker #6: So in a lot of regions around the country, all of that is centralized within the hub. The patients come there, or the hub makes the decision, and it is just administered at the spoke.

Speaker #6: So the strategy really as it relates to spokes is making sure we are clear on which ones are large enough and are doing their own spinal cord injury care, and whether or not they are the decision-makers with respect to prescribing or whether or not that is done in the hub.

Sean Sciara: The strategy really as it relates to spokes is making sure we are clear on which ones are large enough and are doing their own spinal cord injury care, and whether or not they are the decision-makers with respect to prescribing or whether or not that is done in the hub.

Speaker #4: Sean, now let's transition over to your question about subacute. So I think let me provide some context for your question, Ed. Give me a little leeway here because I'm going to make an assumption.

Dave Marver: Now let us transition over to your question about sub-acute. I think, let me provide some context for your question, Ed. Give me a little leeway here, because I am going to make an assumption. You are asking in the context of the EIGER study that we announced, the first patient enrollment. EIGER is a mobility study, clinical feasibility study for mobility using our ARC-IM system. This is actually a more important study than you may think, because the company was founded to help people with spinal cord injuries stand and walk again. A lot of the early research was in this area, but it used highly repurposed pain stimulators, and they just couldn't deliver the therapy that was envisioned. The founders of ONWARD said, "Let's build a company that can develop purpose-built technology for this mobility indication." All right. Fast-forward now.

Speaker #4: So you're asking, in the context of the IGER study that we announced, about the first patient enrollment. IGER is a mobility study, a clinical feasibility study for mobility using our RKM system.

Speaker #4: This is actually a more important study than you may think, because the company was founded to help people with spinal cord injury stand and walk again.

Speaker #4: And a lot of the early research was in this area. But it used highly repurposed pain stimulators and they just couldn't deliver the therapy that was envisioned.

Speaker #4: And so the founders of ONWARD said, "Let's build a company that can develop purpose-built technology for this mobility indication." All right. Fast forward now.

Speaker #4: We're first seeking to commercialize the blood pressure indication for RKM, and now we're ready to move on to the path of commercialization for the mobility indication.

Dave Marver: We're first seeking to commercialize the blood pressure indication for ARC-IM, and now we're ready to move on to the path of commercialization for the mobility indication, starting with EIGER. EIGER is a clinical feasibility study. The purpose of it is to identify the best patient population and to inform the design of the eventual pivotal study. It's a precursor to the pivotal study that will, we hope, result in regulatory approval for the mobility indication for ARC-IM. Okay, thank you for that. EIGER includes 12 patients. Some are chronic, so they've been injured for one year or more, and some are sub-acute. They've been injured for six weeks or less. Ed's question is why sub-acute? Is it because the population enlarges, or is it because of efficacy? Certainly the population will increase somewhat. But it's mainly because of efficacy, Ed.

Speaker #4: Starting with IGER. IGER is a clinical feasibility study. The purpose of it is to identify the sort of the best patient population and to inform the design of the eventual pivotal study.

Speaker #4: So it's a precursor to the pivotal study that will we hope result in regulatory approval for the mobility indication for RKM. Okay. Thank you for that.

Speaker #4: Now, IGER includes 12 patients. Some are chronic, so they've been injured for one year or more, and some are subacute, meaning they've been injured for six weeks or less.

Speaker #4: So Ed's question is, why subacute? Is it because the population enlarges, or is it because of efficacy? And certainly, the population will increase somewhat.

Speaker #4: But it's mainly because of efficacy, Ed. After a person has spinal cord injury, they lose muscle mass. They lose coordination and proprioception. And the thesis here is that if we intervene early, within six weeks of the injury, before that muscle atrophy occurs, then in fact, the mobility therapy will be that much more effective.

Dave Marver: After a person has spinal cord injury, they lose muscle mass, they lose coordination and proprioception. The thesis here is that if we intervene early, within six weeks of the injury, before that muscle atrophy occurs, then in fact, the mobility therapy will be that much more effective. All right. That's about the longest answer you're ever going to get from me, but I hope it's helpful. Now on Empower BP, I'm going to turn it over to Ali, and I don't know if we're going to give you the specific costs, but we can give you the overall cost for Empower BP and give you some sense for how far along we are. Would that be okay?

Speaker #4: All right. That's about the longest answer you're ever going to get from me, but I hope it's helpful. Now, on Empowered BP, I'm going to turn it over to Ali.

Speaker #4: And I don't know if we're going to give you the specific costs. But we can give you the overall cost for Empowered BP and give you some sense for how far along we are?

Speaker #4: Would that be okay?

Speaker #7: Absolutely.

Ali Kiboro: Absolutely.

Speaker #4: Ali? So housekeeping for you and what I would say is I think it's fair for you to assume that the majority of this increase year over year has been driven by Empowered BP.

Dave Marver: Ali?

Ali Kiboro: Okay. So housekeeping for you, Ed. What I would say is, I think it's fair for you to assume that the majority of this increase year-over-year has been driven by Empower BP. We have also spent, in terms of registrations into new geographies, but I think it's fair for you to assume that the majority of this increase you are seeing is coming from Empower BP. Perfect. That was pretty clear. Thank you.

Speaker #4: We all have also spent in terms of registrations into new geographies, but I think it's fair for you to assume that the majority of this increase you are seeing is coming from Empowered BP.

Speaker #7: That's pretty fair. Thank you.

Ed Hall: Perfect. That was pretty clear. Thank you.

Speaker #4: Okay.

Dave Marver: Okay.

Ali Kiboro: Okay.

Speaker #2: Thank you. We will now move on to our next question. Our next question comes from the line of Matthew Skirt Stono from KBC Securities.

Operator: Thank you. We'll now move on to our next question. Our next question comes from the line of Matthijs Geerts from KBC Securities. Please go ahead. Your line is open.

Speaker #2: Please go ahead. Your line is open.

Speaker #6: Hi. And congrats on the results. I had a question on the amount of patients that you convert in the clinic to home-use use devices.

Matthijs Geerts: Hi, and congrats on the results. I had a question on the amount of patients that convert in the clinic to home use devices. How many patients decide to buy a home use after they first encountered a device in the clinic? Also, I was wondering about ex-US, ex-Europe expansion. Do you already have some plans to enter some markets outside of Europe? What are major hurdles that you need to overcome to reach them? Thanks.

Matthijs Geerts Danau: Hi, and congrats on the results. I had a question on the amount of patients that convert in the clinic to home use devices. How many patients decide to buy a home use after they first encountered a device in the clinic? Also, I was wondering about ex-US, ex-Europe expansion. Do you already have some plans to enter some markets outside of Europe? What are major hurdles that you need to overcome to reach them? Thanks.

Speaker #6: So, how many patients decide to buy a home-use device after they first encounter a clinic device in the clinic? And then also, I was wondering about the next US versus Europe expansion.

Speaker #6: Do you already have some plans to enter some markets outside of Europe and what are the major hurdles that still need to overcome to reach them?

Speaker #6: Thanks.

Speaker #4: Thank you. So I'm going to take the first part and then Sean, I'm going to give you the second part. And so let's start that way.

Dave Marver: Thank you. I am going to take the first part, and then Sean, I am going to give you the second part. Let us start that way. We are not really breaking down the clinic versus home sales at this point. What we do know is there is a lot of demand for home use. That has been validated by some third-party research. We are selling more units for home use than clinic units. That is a trend that started in Q1. It continued in Q2, and we expect it to continue actually for the foreseeable future. That is really what helps this therapy to scale, and it is going to impact our top line. With that, let me hand it over to Sean to talk about what we are doing outside the US in terms of our field organization and our progress to date.

Speaker #4: So we're not really breaking down the clinic versus home sales at this point. What we do know is there's a lot of demand for home use that's been validated by some third-party research.

Speaker #4: And we are selling more units for home-use than clinic units. And that's a trend that started in the first quarter. It continued in the second quarter.

Speaker #4: And we expect it to continue, actually, for the foreseeable future. And that's really what helps this therapy to scale, and it's going to impact our top line.

Speaker #4: So with that, let me hand it over to Sean to talk about what we're doing outside the US in terms of our field organization and our progress to date.

Speaker #6: Absolutely. Thanks, Dave. So the question about expansion outside of the US, we are starting to grow and to do that. So I've been in the United States for about six quarters.

Sean Sciara: Absolutely. Thanks, Dave. The question about expansion outside of the US, we are starting to grow and to do that. We have been in the United States for about six quarters. The next geography that we have expanded into has been Europe. As we recall, as we spoke to there, we started commercialization in Europe late last year and are now in seven countries. In addition to that expansion, the first part of this year has been building commercial capabilities to allow us to continue to expand, but also to support the therapy once it has been introduced. Our sales organization there has grown. It is a combination of direct selling resources and then distribution partners, distributors, as we work across both Western and look to Eastern Europe. Beyond that, we are looking at expansion into other geographies.

Speaker #6: The next geography that we have expanded into has been Europe. And as we recall, as we kind of spoke to there, we started commercialization in Europe late last year.

Speaker #6: And are now in seven countries. And the in addition to that expansion, the first part of this year has been building commercial capabilities to allow us to continue to expand, but also to support the therapy once it's been introduced.

Speaker #6: So our sales organization there has grown. It's a combination of direct selling resources and distribution partners, distributors, as we work across both Western and look to Eastern Europe.

Speaker #6: Beyond that, we are looking at expansion into other geographies. We've launched into one country outside of the United States and Europe. And are evaluating others.

Sean Sciara: We have launched into one country outside of the United States and Europe and are evaluating others to trade off the work required to enter versus the opportunity that is in there, and are staging those out so that we can roll them out over time. Part of your question was what were the challenges in doing that? The challenges in any market are twofold. A lot of these markets require us to find an appropriate distribution partner, so somebody that will work with us to commercialize a new therapy that we feel comfortable with and confident in. The second challenge is just the work required to do the associated regulatory filings and the operational pieces around getting a product into a new country. So the standard operational things that just come with commercializing medical technologies.

Speaker #6: To trade off the work required to enter versus the opportunity that is in there, and are staging those out so that we can roll them out over time.

Speaker #6: Part of your question was, what were the challenges in doing that? The challenges in any market are twofold. A lot of these markets require us to find an appropriate distribution partner.

Speaker #6: So somebody that will work with us to commercialize a new therapy that we feel comfortable with and confident in. And then the second challenge is just the work required to do the associated regulatory filings and the operational pieces around getting a product into a new country.

Speaker #6: So, the standard operational things that just come with commercializing medical technologies.

Speaker #4: Thank you, Sean. Next question from David.

Dave Marver: Thank you, Sean. Next question from David.

Speaker #2: Thank you. Our next question comes from the line of David. From Degreef Petercam. Please go ahead.

Operator: Thank you. Our next question comes from the line of David from Degroof Petercam. Please go ahead.

Speaker #6: Okay. Perfect. Do you hear me?

[Analyst] (Degroof Petercam): Okay, perfect. Do you hear me?

David Seynnaeve: Okay, perfect. Do you hear me?

Speaker #4: Yes.

Dave Marver: Yes.

Speaker #6: Okay, excellent. Thank you for taking my question, and congratulations on the update. My question is about the home-use conversion rate, which is somewhat related to an earlier one as well.

[Analyst] (Degroof Petercam): Okay, excellent. Thank you for taking my question. Congrats on the update. A question on the home use conversion rate, so a bit related to an earlier one as well. Do you see meaningful differences between penetrated clinics in transitioning patients to home use? If so, what separates these high converted clinics from the slower ones? I presume you see differences between VA clinics and more regional smaller ones, but would be interesting to hear if there's any other factors at play, such as level of clinician training, patient demographics, and so on. Then maybe secondly, also more broadly, in light of the early feasibility studies starting and already ongoing in adjacent indications, when we can expect some more info on further program prioritization and more detailed timelines therefore, which obviously depends on data, but would be pretty useful for modeling purposes and such. Thank you.

David Seynnaeve: Okay, excellent. Thank you for taking my question. Congrats on the update. A question on the home use conversion rate, so a bit related to an earlier one as well. Do you see meaningful differences between penetrated clinics in transitioning patients to home use? If so, what separates these high converted clinics from the slower ones? I presume you see differences between VA clinics and more regional smaller ones, but would be interesting to hear if there's any other factors at play, such as level of clinician training, patient demographics, and so on. Then maybe secondly, also more broadly, in light of the early feasibility studies starting and already ongoing in adjacent indications, when we can expect some more info on further program prioritization and more detailed timelines therefore, which obviously depends on data, but would be pretty useful for modeling purposes and such. Thank you.

Speaker #6: So, do you see meaningful differences between penetrated clinics in transitioning patients to home use, and if so, what separates these high-converted clinics from the slower ones?

Speaker #6: I presume you see differences between VA clinics and more regional, smaller ones, but it would be interesting to hear if there are any other factors at play, such as level of clinician training, patient demographics, and so on.

Speaker #6: And then maybe secondly, also more broadly, in light of the early feasibility studies starting and already ongoing in adjacent indications, when can we expect some more information on further program prioritization and more detailed timelines?

Speaker #6: Therefore, which obviously depends on data, but would be pretty useful for modeling purposes and such. Thank you.

Speaker #4: Thank you, David. So Sean, how about you take the question about kind of that dynamics that might inform a clinic's proclivity to prescribe for home-use?

Dave Marver: Thank you, David. Sean, how about you take the question about that dynamics that might inform a clinic's proclivity to prescribe for home use as more of a general response there on what you are observing in the field.

Speaker #4: This is more of a general response there on what you're observing in the field.

Speaker #6: Certainly. I would caveat the entire answer by saying it's still early in this process. So we're learning together with the clinics on how they want to establish kind of a workflows for doing this type of activity.

Sean Sciara: Certainly. I would caveat the entire answer by saying it is still early in this process. We are learning together with the clinics on how they want to establish workflows for doing this type of activity. The uptake in clinic is, I do not think you can generalize it between large or small or things of that nature. I think it comes down to something that is just more human nature and that some people are earlier adopters and lean into new things quicker, and others want to see it become a little bit more established in the field first. Certainly, we are partnering aggressively with early adopters in that early majority. The pace with which we have established the footprint would certainly indicate that there are a lot of those and are building significant momentum.

Speaker #6: The uptake in clinic is, I don't think you can generalize it between large or small or things of that nature. I think it comes down to something that's just more human nature and that some people are earlier doctors and lean into new things quicker.

Speaker #6: And others want to see it become a little bit more established in the field first. So certainly, we are partnering aggressively with kind of early adopters in that early majority.

Speaker #6: And the pace with which we have established the footprint would certainly indicate that there are a lot of those, and we are building significant momentum.

Speaker #6: In the home-use setting and the transition in prescribing for home-use, there are very little barriers really from the clinicians in prescribing it for home-use.

Sean Sciara: In the home use setting and the transition in prescribing for home use, there are very little barriers really from the clinicians in prescribing it for home use. The biggest are just ensuring that you have a patient that would benefit, a patient that could actually use it in a home use setting, and a patient that has someone to help them, whether it is a family member or caregiver or somebody that can do things as simple as just put the electrodes on. It can be a variable that needs to be considered in that. But the transition to home use is likely to continue to be much more dependent on just ability for access, either through insurance or ability to pay.

Speaker #6: The biggest factors are just ensuring that you have a patient who would benefit—a patient who could actually use it in a home-use setting, and a patient who has someone to help them.

Speaker #6: Whether it's a family member or a caregiver or somebody that can do things as simple as just put the electrodes on. It tends it hasn't it can be a variable that needs to be considered in that.

Speaker #6: But the transition to home use is likely to continue to be much more dependent on just the ability for access, either through insurance or the ability to pay.

Speaker #4: Thank you, Sean.

Dave Marver: Thank you, Sean. The second question, David, was about our pipeline, really, our early feasibility studies. Indeed, we have them ongoing in Parkinson's disease, stroke. We are looking at new indications such as urinary incontinence, for example. I think it is important to note that the company is largely deploying its capital on existing and near-term indications, so driving revenue uptake for ARC-EX and then getting ARC-IM through the Empower BP study. We are advancing these pipeline indications largely with the benefit of grant funding. A lot of this work is being driven by our science and research partners in Switzerland and around the world. The pace of this is, for the most part, dictated by the pace at which these studies can be enrolled. We do not, at this time, have what I would say solid dates for you for these indications.

Speaker #6: The second question, David, was about

Speaker #4: our pipeline really, our early feasibility studies. And indeed, we have them ongoing in Parkinson's disease, stroke, we're looking at new indications such as urinary incontinence, for example.

Speaker #4: And I think it's important to note that the company is largely deploying its capital on new and existing and near-term indications. So driving revenue uptake for RTX and then getting ARC-IM through the entire BP study.

Speaker #4: And we're advancing these pipeline indications with largely with the benefit of grant funding and a lot of this work is being driven by our science and research partners in Switzerland and around the world.

Speaker #4: So the pace of this is, for the most part, dictated by the pace at which these studies can be enrolled. So we don't, at this time, have what I would say are solid dates for you for these indications.

Speaker #4: And you've got a conservative management team here. So I think what we would prefer to do is let these early feasibility studies run their course, make sure that they are that the indications indeed show the promise that we expect and then we can run the proper pivotal studies at scale and get these things approved the right way.

Dave Marver: You have a conservative management team here. I think what we would prefer to do is let these early feasibility studies run their course, make sure that the indications indeed show the promise that we expect, then we can run the proper pivotal studies at scale and get these things approved the right way. We are excited about them certainly, and we are glad that we have them. But I think we are not, at this time, prepared to communicate timelines.

Speaker #4: So we're excited about them, certainly, and we're glad that we have them. But I think we're not at this time prepared to communicate timelines.

Speaker #6: Okay.

Sébastien Cros: Okay.

Speaker #4: Okay. Thank you. Yeah.

Dave Marver: Okay. Thanks.

Sébastien Cros: Yeah. Thank you. A few questions came in via the web platform. Maybe we can take those.

Speaker #5: Thank you. A few questions came in via the web platform. Maybe we can take those.

Speaker #4: All right. Sure. First question is, what percentage of the units that are "supplied" to VA patients were actually purchased? So just a little bit of nuance here.

Dave Marver: All right. Sure. First question is, what percentage of the units that are "supplied" to VA patients were actually purchased? Just a little bit of nuance here, is that the way the VA purchases devices like ours for home use is at first they are prescribed for a 3-month paid evaluation. The VA pays for use of the device during those 3 months. At the completion of that period, the device is then purchased and what was paid during the evaluation is netted out of the purchase price. That is how the economics work. What we are observing thus far is that 90% plus of those patients who have the paid evaluation are converting to actual purchases. Very high rate of conversion there. Okay, next question. Revenue for ARC-EX appears to have increased significantly in Q2. What are expectations for ARC-EX sales in the second half?

Speaker #4: And is that the way the VA purchases devices like ours, for home-use, is it first they're prescribed for a three-month paid evaluation. So the VA pays for use of the device during those three months at the completion of that period.

Speaker #4: The device is then purchased and the what was paid during the evaluation is netted out of the purchase price. So that's how the economics work.

Speaker #4: What we're observing thus far is that 90% plus of those patients who have the paid evaluation are converting to actual purchases. So very high rate of conversion there.

Speaker #4: Okay. Next question. Revenue for RTX appears to have increased significantly in Q2. What are expectations for RTX sales in the second half? So we don't issue guidance here.

Dave Marver: We don't issue guidance here because the commercialization is still fairly early. For the most part, we ramped up home use starting at the beginning of this year. Same with Europe, and we are still learning as a company. It is a brand new market, brand new technology. We are pioneering this. Again, conservative management team. I would not assume that the growth rate is going to continue at this pace, but we do not know. We also expect that there will be some seasonality because this is capital equipment. Normally in capital equipment, things are fairly flat mid-year, and then you see an increase in the Q4. Those are general trends that are observed in capital equipment. We are not issuing guidance, and I do not want to set expectations. Just know that we are going to continue pushing very hard to expand this therapy globally. Okay, next.

Speaker #4: Because the commercialization is still fairly early for the most part. We ramped up home-use starting at the beginning of this year. Same with Europe and we're still learning as a company.

Speaker #4: It's a brand-new market, brand-new technology. We're pioneering this. And again, we have a conservative management team, so I would not assume that the growth rate is going to continue at this pace.

Speaker #4: But we don't know. And we also expect that there'll be some seasonality because this is capital equipment. Normally in capital equipment, things are fairly flat.

Speaker #4: Mid-year and then you see an increase in the fourth quarter. So those are general trends that are observed in capital equipment. But we're not issuing guidance and I don't want to set expectations.

Speaker #4: Just know that we're going to continue pushing very hard to expand this therapy globally. Okay. Next, when do we expect the first decisions on codes from US insurance to cover costs for RTX?

Dave Marver: When do we expect the first decisions on codes from US insurance to cover costs for ARC-EX? Sean, if you could give an overview of the reimbursement milieu for ARC-EX in the US.

Speaker #4: Maybe Sean, just if you could give an overview of the reimbursement milieu for RTX in the US.

Speaker #6: Absolutely. So veterans in the US Veterans Administration healthcare system can have access to it in the home-use today. Without waiting for broader insurance decisions.

Sean Sciara: Absolutely. Veterans in the US Department of Veterans Affairs healthcare system can have access to it in the home use today without waiting for broader insurance decisions. Outside of that, we have completed our submission to the group within CMS that assigns coding to devices, and we expect to hear back from them in Q4. That would be the first big step forward to engaging payers. In parallel, in the interim, we have established a program that we run and partner with clinics to help their patients engage their insurance companies to start to get some level of reimbursement on a case-by-case basis. This is not a service that will lead to broad coverage, but this is a service that we will provide to clinics and patients to help them engage insurance providers on a case-by-case basis. That was just launched in July.

Speaker #6: And then outside of that, we have completed our submission to the group within CMS that assigns coding. To devices. And we expect to hear back from them in Q4.

Speaker #6: That would be the first big step forward to engaging payers. In parallel, in the interim, we have established a program that we run and partner with clinics to help them help their patients engage their insurance companies to start to get some level of reimbursement on a case-by-case basis.

Speaker #6: So this wouldn't be a this isn't a service that will lead to broad coverage, but this is a service that we will provide to clinics and patients to help them engage insurance providers on a case-by-case basis.

Speaker #6: And that was just launched in July.

Speaker #4: Yeah. Excellent. Thank you, Sean. So again, just to reiterate that, we can sell to the VA now. We can sell for self-pay. We're establishing this capability to assist patients who want to buy the device themselves to get reimbursement through their insurers on a case-by-case basis.

Dave Marver: Yeah. Excellent. Thank you, Sean. Again, just to reiterate that we can sell to the VA now. We can sell for self-pay. We are establishing this capability to assist patients who want to buy the device themselves to get reimbursement through their insurers on a case-by-case basis. So taking a lot of action here to expand access to this important and breakthrough technology.

Speaker #4: So taking a lot of action here to expand access to this important and breakthrough technology.

Speaker #5: I can see we have a follow-up question from Ed Hall from CIFO. Maybe, Mel, could you open Ed's line, please?

Sébastien Cros: I can see we have a follow-up question from Edward Hall from Stifel. Mel, could you open Ed's line, please?

Speaker #2: Thank you. Ed Hall from CIFO, your line is now open. Please go ahead.

Operator: Thank you. Edward Hall from Stifel, your line is now open. Please go ahead.

Speaker #7: Perfect. Thank you very much. Yeah, just to follow up on I think you talked about sort of the your capital spend on near-term RTX and power.

Edward Hall: Perfect. Thank you very much. Just to follow up on, I think you talk about your capital spend on near-term ARC-EX and Empower BP. I was just curious about the amount of committed capital you would need for indication expansion in and around ARC-EX. I think we've seen from some evidence that there is off-label interest in this device. How would this evolve in the mid-term? Is this something that clinics would commit to do investigator-led studies, or is this something you would have to do? What are the steps that you would need to take to get ARC-EX penetrating other aspects of the spine? Thanks.

Ed Hall: Perfect. Thank you very much. Just to follow up on, I think you talk about your capital spend on near-term ARC-EX and Empower BP. I was just curious about the amount of committed capital you would need for indication expansion in and around ARC-EX. I think we've seen from some evidence that there is off-label interest in this device. How would this evolve in the mid-term? Is this something that clinics would commit to do investigator-led studies, or is this something you would have to do? What are the steps that you would need to take to get ARC-EX penetrating other aspects of the spine? Thanks.

Speaker #7: BP: But I was just curious about the amount of committed capital you would need for indication expansion in and around RTX. I think we've seen from some evidence that there is off-label interest in this device.

Speaker #7: So how would this evolve in the mid-term? Is this something that clinics would commit to do in investigator-led studies? Or is this something you would have to do?

Speaker #7: Sort of what are the steps that you would need to take to get RTX sort of penetrating other aspects of the spine? Thanks.

Speaker #4: Yeah. Thanks, Ed. And the survey, your work you did, did indicate that there is some off-label use. Obviously, we can't promote it, but there's a great deal of interest in using this breakthrough technology to address a lot of recovery targets.

Dave Marver: Yeah. Thanks, Ed. The survey work you did did indicate that there is some off-label use. Obviously, we can't promote it, but there's a great deal of interest in using this breakthrough technology to address a lot of recovery targets. Thus far, we have a number of investigator-initiated research projects that we're in part supporting. We're going to have to just wait and see where the evidence leads and also have discussions with FDA on what quantum of evidence is required to get regulatory approval for these new indications. This is a Class 2 device, which makes it a bit easier. It's also a breakthrough device, which allows us to have frequent conversations with the VA. In some cases, it may be that the investigator-initiated research data is enough.

Speaker #4: Thus far, we have a number of investigation sorry, investigator-initiated research projects that we're in part supporting. And we're going to have to just wait and see where the evidence leads.

Speaker #4: And also have discussions with FDA on what quantum of evidence is required to get regulatory approval for these new indications. This is a class 2 device, which makes it a bit easier.

Speaker #4: It's also a breakthrough device, which allows us to have frequent conversations with VA. So in some cases, it may be that the investigator-initiated research data is enough.

Speaker #4: In other cases, we may have to bring together two or three sites to aggregate and offer multi-site data. I think it's TBD. But big picture, it should be a relatively efficient and low-cost pathway.

Dave Marver: In other cases, we may have to bring together two or three sites to aggregate and offer multi-site data. I think it's TBD. But big picture, it should be a relatively efficient and low-cost pathway. Certainly nothing like Empower BP with a Class III PMA device like you're seeing with ARC-IM.

Speaker #4: Certainly nothing like in Power BP with a class 3 PMA device like you're seeing with ARC-IM.

Speaker #7: Thank you very much.

Edward Hall: Thank you very much.

Ed Hall: Thank you very much.

Speaker #5: And additional questions came in via the platform.

Sébastien Cros: Additional questions came in via the platform.

Speaker #4: Okay. So the question is just how quickly are we enrolling for in Power BP? Sherry, do you want to just comment on our goals and what we need to get to the spring interim readout?

Dave Marver: Okay, so the question is just how quickly are we enrolling for Empower BP. Shari, do you want to just comment on our goals and what we need to get to the spring interim readout?

Speaker #2: Sure, Dave. I can take that. So, our goal is to reach the enrollment number that we need to conduct the interim analysis. We'll hit that number by the end of this year.

Shari O'Quinn: Sure, Dave, I can take that. Our goal is to get to the enrollment number that we need to do the interim analysis. We will hit that number by the end of this year, and then we expect to do the interim analysis early next year, by the end of Q1, early Q2.

Speaker #2: And then we expect to do the interim analysis early next year. By the end of Q1, early Q2.

Speaker #4: Thank you, Sherry. Also a question here on are we still considering a NASDAQ listing? Good question. We did announce in the past several months that we had filed an F1, an S1 equivalent.

Dave Marver: Thank you, Shari. Also a question here on are we still considering a Nasdaq listing? Good question. We did announce in the past several months that we had filed an F1, an S1 equivalent, with the SEC. I would describe us as poised and ready. But the market conditions right now are not conducive to a listing. One of the important considerations is how large cap med tech is doing. Many of the large cap med tech companies are in a bit of a rocky period, and that affects investor appetite in the US for new listings.

Speaker #4: With the SEC. And so I would describe us as poised and ready. But the market conditions right now are not conducive to a listing.

Speaker #4: One of the important considerations is how large cap MedTech is doing. Many of the large cap MedTech companies are in a bit of a rocky period.

Speaker #4: And that affects investor appetite in the US for new listings. So we're going to, as we said when we announced the filing, we want to be poised, but we also want to add the NASDAQ listing when market conditions are supportive and positive.

Dave Marver: We are going to, as we said when we announced the filing, we want to be poised, but we also want to add the Nasdaq listing when market conditions are supportive and positive and buoyant so that we can have a really well-supported listing and the stock will trade well in the aftermarket. Thank you very much. Another question is when will ONWARD achieve cash flow break even? I am going to turn that over to Ali.

Speaker #4: And buoyant so that we can have a really well-supported listing and the stock will trade well in the aftermarket. Thank you very much. Another question is when will ONWARD achieve cash flow break-even?

Speaker #4: So I'm going to turn that over to Ali.

Speaker #5: Thanks, Dave. So as you know, it's early days. We've just started to commercialize our first product last year into this year. We've not guided as to when we will get there.

Ali Kiboro: Hi, Dave. As you know, it is early days. We have just started to commercialize our first product last year into this year. We have not guided as to when we will get there. It is going to essentially be a function of the growth of the company and the future indication and the investment that we are making. But we have not guided to when our company goes break even.

Speaker #5: It is going to essentially be a function of the growth of the company and the future indications and the investments that we're making. But we have not guided to when our company goes break-even.

Speaker #4: Yeah. And let me just reassure everybody. We are an investment mode here. We're commercializing our first technology. We're spending money on the pivotal study for our second technology.

Dave Marver: Yeah, let me just reassure everybody, we are in investment mode here. We are commercializing our first technology. We are spending money on the pivotal study for our second technology. We also realize it is important to be disciplined in our use and allocation of capital. As I said earlier in the call, we are deploying the vast majority of our capital toward those two pursuits and associated activities, and we are advancing our pipeline with the benefit of grant funding. We want to be cash flow positive as soon as everyone else. We get diluted, too, when additional equity capital is needed. We need to grow our way into that, and we need to grow the top line so we can start to generate cash from operations, and that is absolutely our intent.

Speaker #4: But we also realize it's important to be disciplined in our use and allocation of capital. So, as I said earlier in the call, we are deploying the vast majority of our capital toward those two pursuits.

Speaker #4: ...and associated activities. We're advancing our pipeline with the benefit of grant funding. We want to be cash flow positive as soon as everyone else.

Speaker #4: We get diluted too when additional equity capital is needed. But we need to grow our way into that. And we need to grow the top line so we can start to generate cash from operations and that is absolutely our intent.

Speaker #4: Kind of a related question is whether if and when capital is needed, do we intend to issue more shares or tap the BlackRock facility?

Dave Marver: Kind of a related question is whether if and when capital is needed, do we intend to issue more shares or tap the BlackRock facility? Again, we are in a great place right now with our cash position at over EUR 81.5 million at the end of the H1. We have cash into the Q1 of 2028. I would say that we are inclined to use equity capital going forward, and we are inclined to use the BlackRock facility if we need to bridge to a milestone that may help us raise equity capital at a higher valuation that is less dilutive. We are generally not inclined to draw more of that facility and incur interest expense and so on. I do not want to answer that question definitively right now. I am just going to say that we are more inclined to use equity capital than debt capital.

Speaker #4: Again, we're in a great place. Right now, with with our cash position at over 81 and a half 81 and a half million euros at the end of the first half.

Speaker #4: So we have cash into the first quarter of 2028. I would say that we're inclined to use equity capital going forward. And we're inclined to use the BlackRock facility if we need to bridge to a milestone.

Speaker #4: That may help us raise equity capital at a higher valuation that's less dilutive. But we're generally not inclined to take to draw more of that facility and incur interest expense and so on.

Speaker #4: So I don't want to answer that question definitively right now. I'm just going to say that we're more inclined to use equity capital than debt capital.

Speaker #4: Okay. The next question. Are we collaborating with Neuralink or a similar companies to do research or to innovate? Really interesting question. So we have our own brain-computer interface.

Dave Marver: Okay, the next question, are we collaborating with Neuralink or similar companies to do research or to innovate? Really interesting question. We have our own brain computer interface, really safe and solid BCI. It has more than 8 years of human safety data, no degradation of signal. It was developed by a top and very innovative neurosurgeon in France. It is a very simple, straightforward procedure for a neurosurgeon. It does not penetrate the brain or the lining of the brain, and the procedural risk is reduced. We like our BCI that we have. However, we have in our ARC-IM spinal cord stimulator, it is also really innovative and flexible architecture. It can communicate wirelessly with other BCI devices.

Speaker #4: Really safe and solid BCI. It has more than eight years of human safety data. No degradation of signal. It was developed by a top and very innovative neurosurgeon in France.

Speaker #4: So it's a very simple, straightforward procedure for a neurosurgeon. It doesn't penetrate the brain or the lining of the brain. And so the procedural risk is reduced.

Speaker #4: So we like our BCI. That we have. However, we have in our ARC-IM spinal cord stimulator, it's also a really innovative and flexible architecture.

Speaker #4: So it can communicate wirelessly with other BCI devices. So we have the option going forward to use our own BCI or to collaborate with other brain-computer interfaces and their and those companies.

Dave Marver: We have the option going forward to use our own BCI or to collaborate with other brain computer interfaces and those companies should it make sense to advance our therapies. Our therapies are focused on restoring movement of a person's own paralyzed limb. We are in discussions, some regular, with many of the leading BCI companies around the world. A few, if any, are ready to do clinical research, so human studies like we can do today with our own BCI. I would say, just like with the Nasdaq IPO, we are poised and ready, but we are waiting for these other companies to catch up with us. Any other questions?

Speaker #4: Should it make sense? To advance our therapies. And our therapies are focused on restoring movement of a person's own paralyzed limbs. We are in discussions, some regular, with many of the leading BCI companies around the world.

Speaker #4: A few, if any, are ready to do clinical research. So human studies like we can do today with our own BCI. So I'd say just like with the NASDAQ IPO, we're poised and ready.

Speaker #4: But we're waiting for these other companies to catch up with us. Any other questions? All right. Thanks, everyone, for joining. I want to thank my team for their contributions. I enjoyed being with you today.

Sébastien Cros: No more questions.

Dave Marver: All right. Thanks, everyone, for joining. I want to thank my team for their contributions. Enjoyed being with you today, and we appreciate everyone's support for our mission to help people with spinal cord injury enjoy better lives.

Speaker #4: And we appreciate everyone's support for our mission to help people with spinal cord injury enjoy a better lives.

Speaker #5: Thank you very much. Mail back to you.

Sébastien Cros: Thank you very much. Mel, back to you.

Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Speakers, please stand by.

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