Onward Med Nv

Welcome everyone to Onward's webcast. Earlier today, we shared our results for the first quarter of 2025 and year-to-date highlights via a press release available on our site. The replay of this webcast will also be made available on our investor relations platform after the session. Before we get started, please take a moment to read this page. Today's presentation includes four looking statements, which should be considered with the appropriate level of caution as outlined in the disclaimer. Today I'm joined by Dave Marver, CEO, and Amaury Fraser, Senior Finance Director. Dave and Amaury will provide an update on our progress before we open 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.

thank you sharon thank you sev thank you to all of you who are joining us today as is our tradition i like to start with a company overview for those of you who are new to the story onward is pioneering therapies to restore movement function and independence in people with spinal cord injury and other movement disabilities we are doing so with three persistent neuromodulation platforms ARC-EX, ARC-IM, and ARC-BCI. ARC-EX delivers ARC therapy externally through the skin. ARC-IM delivers ARC therapy via a fully implanted platform. And ARC-BCI pairs ARC-IM with an implanted brain-computer interface to restore thought-driven movement. We're here because there are 9 million people worldwide living with spinal cord injury. It is a large and expensive unmet need. The TAM is significant at $17 billion, and we're attacking this with innovation. We have 10 FDA breakthrough device designation awards and over 150 issued patents, nearly 300 if you include country validations. In terms of stage, we are now commercial. The ArcheX system is available in the United States with excellent initial demand and market uptake. And our future is bright. We have a robust pipeline that includes implantable and brain-computer interface technologies, including for Parkinson's disease and for stroke. Some of the highlights for the quarter. Very strong early U.S. commercial traction. That's the most important thing. We're really pleased with how the quarter progressed, and we also made significant advancements in our pipeline on the science and technology fronts. Commercially, we met our Q1 objectives for what was the phase or limited initial launch of ARC-EX. We trained and deployed our field organization. We established the sales and service process, we built a roster of reference clinics, and we sold 10 units, which was precisely our target. Demand indications are also very strong. I'll get into those a bit later. In terms of technology, we announced our fourth and fifth successful BCI implants to restore thought-driven movement. We also announced the first inhuman implant of the Arc IM lumbar lead, which is designed to help restore mobility. On the scientific front, the Pathfinder 2 study results were published in the journal Neuromodulation Technology at Neural Interface, showing that sustained access to ArcheX therapy can continue to drive functional improvements. In fact, participants continue to make gains after one year of treatment. And then on the financial front, we established a sponsored Level 1 ADR program in the U.S. to facilitate American investor trading. All right, let's dig into the launch, which is, I'm sure, foremost on most of your minds. Start out with the demand indication. Very strong. We're really pleased. Since FDA authorization in December of 2024, we have received over 3,000 leads globally. These are inbound indications of interest. Over 2,000 in the U.S. alone, 300 of which are from clinics. We are tracking exactly to our planned phase launch, strong demand, strong early traction, building momentum in the first half for the full year. So starting in Q1, which is what we call phase zero, we wanted to deploy up to 10 units, learn how to start up a clinic, get our sales organization up and running and trained and so forth, done. We sold 10 units. In the first half, our target is to sell up to 30 units, At this point, our expectation is that we will indeed sell approximately 30 units in the first half, which is almost over. It's just a couple of weeks to go. Second half of the year, we want to expand the market, expand indications, and indeed our applications for home use in the U.S. and CE Mark, which will allow us to commercialize in Europe. Both are on track. So this is really a story of momentum, and we're delighted with the first indications out there. This is an interesting slide. We wanted to share the illustrative or typical clinic dynamics for a center that, in fact, purchases and deploys RTX. So what we find is, on average, one device will support 15 or 20 patients who are coming into the clinic two to three times a week, and there's often a wait list. There are patients in queue waiting for treatment, which is driving demand for potentially a second unit, but certainly all of this demand could transition once we have home use into, again, latent interest in buying the device. So we're excited about what we're building here with in-clinic use and what that holds for the future. Those of you who follow Onward on social media, this is not a surprise to you. There's a lot of enthusiasm and strong positive feedback from all over the US. I mean, these are representative posts coming from Michigan and Washington State. and Illinois and New York State, the device is being very well received. And this is sort of a qualitative evidence of what I presented on the previous slide, that there's a lot of interest from patients that are already engaged in the therapy or who are waiting in queue to get access to the therapy. We are continuing to build out our sales organization. So we started out with six. But based on the early demand indicators, we've accelerated an increase in that organization. We should be at 12 by early Q3. That includes, as shown here, one sales leader, eight sales territory, three clinical support staff, and then we're devoting one headcount just to focus on government and VA opportunities. Moving beyond the launch, we were busy in several other areas of the business as well, continuing our leadership in the BCI realm. There was also an important ARC-EX publication and the start of our US ADR program. Let me run through these in a bit more detail. So in January, we announced the first commercial sales of the ARC-EX system. Also in January, we announced that the ArcEX system was available on U.S. VA and government online procurement platforms. In February, we announced publication of the Pathfinder 2 results. So more detail to follow, but this is a one-year study showing the benefits of sustained access to ArcEX therapy. In March, we announced that we were awarded grants from the Michael J. Fox Foundation and U.S. Department of Defense to advance our work in Parkinson's disease. Also in March, we announced enrollment of the first participant in an early feasibility study to address mobility challenges in Parkinson's disease. Also in March, we announced first in human use of the Arc IM lumbarly designed to restore standing, stepping, and lower limb mobility. In April, we announced that we had established a U.S. ADR program, and we began trading in ADRs on the OTCQX best market in the U.S. And in May, we announced that the fourth and fifth patients were implanted with the ARC-VCI therapy, advancing our leadership position in VCI. More details follow on those in red. All right, so first Pathfinder 2. So this is a one-year study showing the benefits and importance of sustained access to RKX therapy. This is a multicenter clinical trial, 10 participants with chronic spinal cord injury. In aggregate, there were 120 sessions of activity-based therapy combined with RKX therapy. Some key takeaways here, significant functional improvements after one year of RKX therapy. The improvements were observed throughout the one-year treatment period with no plateau. That's important. In our clinical study, Uplift, we only had two months of treatment. So now this study shows what occurs after one year of treatment, and indeed, continued benefits during that one-year treatment period. Three individuals improved their AIS classification, and one individual switched from a complete to an incomplete injury. So important study coming out of the UK. We also, as I said before, introduced a U.S. ADR program, which was intended to enhance U.S. investor access, broaden our shareholder base, and increase stock liquidity. So ADRs are designed to make it easier for American investors to purchase, hold, and sell U.S. instruments representing non-U.S. securities. They offer several benefits, including convenience, they trade in U.S. dollars, and accessibility. It allows investors to gain exposure to international companies without opening a foreign brokerage account. And then BNY Mellon sponsored this on our behalf. And as stated here, they're pleased to work with Onward Medical on the important step to expand our presence in the U.S. market. We also announced, importantly, a continued BCI leadership with our fourth and fifth successful ARC BCI implants. So two additional BCI implants occurred for two different indications, one for upper limb, one for lower limb movement. We are planning additional implants in the future, including for stroke, and we are working on the technology as well. So we're advancing the BCI technology that was exclusively in license last October. Experience so far is good. This is a quote from neurosurgeon Jocelyn Block. We continue to have excellent experience with Onward Arc BCI therapy, which provides the data and resolution we need with a less invasive surgery than is required with other BCI platforms. And we benefit from continued media coverage, particularly in the US, where we've had some high-profile coverage recently, which creates additional visibility for the company and our technology. Two examples here, 60 Minutes and 60 Minutes Overtime. Pictured here is Anderson Cooper, probably the US's most high-profile news personality, and 60 Minutes is one of the longest-lasting and most highly respected news programs on the air in America. We were also recently named one of Fast Company's World Changing Ideas. for 2025. And this is important. It's good for recruiting. It's good for investor engagement. And we think eventually it's also going to introduce marketing efficiencies because we're growing awareness for the company in important markets. Now I'd like to turn it over to Amori to discuss the Q1 results. Amori, take it away.

Thank you, Dave. We pleased to report revenue of approximately €400,000 for the quarter. This is primarily driven by initial commercial sales of the 10 RKX units in the United States. We ended the quarter with a solid cash balance of 50.5 million euros. Our cash burn for Q1 was 9.5 million euros. This is slightly lower than the previous quarter at the end of 2024. However, as in previous years, we typically see lower spending in Q1 with activities ramping up over the course of the year. We remain focused on managing our cash position with discipline and care to support our long-term value creation. Back to you, Dave.