Neola Medical AB (publ)

We welcome viewers to this live broadcast where Neola Medical has published their fourth and final report for the fiscal year of 2025. And joining us here in the digital studio is CEO Hanna Sjöström as well as CFO David Folkesson. And we'll turn to Hanna, of course. Welcome, Hanna.

Thank you so much.

You will give us a presentation. Afterwards, I'll return to ask some questions. And I would also like to remind viewers here who are watching to post your questions in the live chat during the broadcast, and I will ask them in the Q&A. So Hanna, go ahead.

Well, a very warm welcome to everyone joining today. So today we will present Neola Medical's year-end Q4 report for 2025 and our Summarizing a year marked by key milestones as we this year really entered the clinical phase, strengthened the organization and continued to build on our strategically important assets. And presenting here today is myself, Hanna Sjöström, I'm CEO of Nyhåla Medical since 2019 and CFO David Folkesson. First, I will present the company, the market and significant events during the full year of 2025 and also, of course, during the quarter. And thereafter, David Falkesson will walk you through the numbers and the financial summary. Before we begin, please do note that today's presentation may include forward-looking statements. Actual results may differ due to risks and uncertainties. including market conditions, regulatory processes, and execution of our strategies. Neola Medical is a deep tech company developing a class two medical device, Neola, neonatal lung analyzer. And it's designed for noninvasive and continuous lung monitoring of preterm born babies. The company was founded in 2016, and we have our headquarters in Lund, where I'm presenting today. The technology behind Neola is based on our patented gas mouse technology, that is gas and scattering media absorption spectroscopy, developed at Lund University and further advanced by Neola Medical. Today, we're in the clinical phase with our medical device aiming for market authorization in the US. And our mission is to advance neonatal care by giving preterm born babies a safer start in life. With Neola, we aim to support healthcare professionals with real-time respiratory insights, enabling instant detection of severe lung complications, providing earlier intervention, proactive care, and ultimately better outcomes for these patients. with the potential to reduce morbidity and improve long-term quality of life. Our revenue model extends beyond the primary sales of Niola main unit, and also includes the sales of disposable probes that are changed daily on the baby, as well as service agreements. And we expect those disposables to really be a key driver of our revenue and margins. We currently hold eight patent families covering medical methods, device, and disposables, ensuring protection of our core innovation, but also enabling scalability to other patient groups. As you've seen in the Q4 report, if you had a chance to read it already, we continue to strengthen our patent portfolio, highlighting five new patent grants in this quarter. We are a Stanford Impact One company, as Neola has been recognized as one of the world's most promising innovations with the potential to really transform neonatal intensive care from day one in clinical use. And this prestigious acknowledgement really underscores the groundbreaking nature of our medical device. As being part of this very exclusive network, we gain unparalleled access to Silicon Valley experts, FDA advisor, regulatory specialists and commercialization support for our market launch in the US. Alongside also collaboration opportunities with the world's leading neonatology doctors. The Stanford Impact One program is led by a professor in neonatology, Janine Furge, one of the neonatologists in the US and key opinion leaders currently giving NEOLA clinical support. And many of the neonatologists and clinicians that we meet emphasize on the insufficient current monitoring methods in today's neonatal care. So doctors rely mainly on manual observation, chest x-ray, blood gas samplings, or pulse oximetry, tools that are very slow, provide only snapshots of the lung status or are invasive or potentially harmful. So in critical cases, results from current monitoring methods may take up to two hours while a baby may already be deteriorating. So with Neola, our goal is to provide continuous real-time monitoring to be very safe for the fragile skin of the neonate with that instant detection of large lung complications. And with Neola, we're not only addressing the monitoring limitation in today's standard of care, but also a growing clinical need as more babies are born preterm. So today, one out of 10 babies are born preterm and often depend on intensive care for survival and for their long-term outcomes. Many of these babies also have underdeveloped lungs that can quickly advance into life-threatening complications and lasting disabilities. And preterm birth remains the leading cause of death for babies under the age of five after pneumonia, with that respiratory failure being the number one primary driver of death. So in neonatal care, every minute counts. And due to the lungs being highly underdeveloped, lung-related conditions in preterm born babies can lead to serious complications if they're not detected very early. And standard of care do not provide a comprehensive picture of baby's lung status. And this limitation really increases the delayed detection of conditions such as the lung collapse, which carries a mortality rate of almost 22% in newborns. So finding a lung collapse early is of utmost importance. And as you can see here from the picture at week 24 of the baby's gestational development, they only have a 50% chance to survive even with neonatal intensive care. And since the development of medical device for children is on average five to 10 years behind device for adults, there is a clear need for a new medical device in the neonatal intensive care. It's driven by a number of factors. We have a growing number of patients. There is an increase in preterm birth worldwide, leading to more children developing RDS, respiratory distress syndrome, and other lung complications that need lung function monitoring continuously. We also have the opportunity to generate high margins globally. say, especially in the US, where the pricing landscape remains favorable. And moreover, there is a rising awareness of the importance of newborn disease prevention, leading to an increase in demand for neonatal intensive care respiratory products and services. And this is something we see specifically in the US at the moment, where there is a major focus on that every single life really matters. And from this perspective, it really adds to a growing market as well for neonatal intensive care. So as preterm birth are increasing worldwide and the number of neonatal intensive care units continue to grow, it has created a very strong demand for improved monitoring solutions. The US is then particularly attractive market because of their high rate of preterm birth. So 10.6% of all babies in the US are born preterm, but also their focus on fertility treatments leading to a lot of twins and triplets and also older mothers, which is also continuously a trend that is driving the market in the US. And currently there are 35,600 beds in neonatal intensive care in the US. And we, together with our market research estimate that 50 to 70% of these beds are directly relevant to have a NEOLA next to it. In the US alone, we have identified 10 leading children's hospitals as per the target for market launch. And importantly, we have already established relationship with two of them. So Stanford in Palo Alto and Cooper in New Jersey. And this is really laying out the foundation for early adoption. So we're not going super wide. We know exactly where to be and which hospitals to focus on. And during the year and Q4 specifically, we're very pleased to have been able to visit both Lucille Packard Children's Hospital at Stanford in Palo Alto and also Children's Regional Hospital at Cooper in New Jersey. And here we have been given an inside look in the clinical environment. really providing perspectives, I would say, from the two leading neonatal centers within the U.S. healthcare system. And for Neola, being able to be here really with feet on the ground in the clinical setting firsthand provides valuable insights into clinical routines, patient flow, and very practical conditions where Neola may be implemented. And here we met with neonatologist and clinical staff to discuss how Neola fits into the today's pathways, workflow, logistics, and practical aspects that are very much relevant for our future real world implementation of Neola. And I will also like to highlight that we as a small company has been able to really secure collaboration with these major clinical hospitals is an indication of the very strong interest in clinical innovation that these centers and the NICU market broadly really has in innovation that can cause a real shift in today's monitoring of these babies. For the hospitals, NEOLA addresses, of course, a pressing clinical need, but also creates a clear financial value, which is important. By enabling faster detection of complications, NEOLA has the potential to shorten length of stay in the NICU and reduce the number of very invasive procedures, such as blood gas samples and chest x-rays. It can potentially also free up nursing time from manual observation, a key factor for these hospitals as the lack of nurses remains a very big problem in the US. So any type of medical device and innovation that can really help ease the burden of the nurses is very welcome in the US hospitals. With that first company introduction and highlights, I want to go into our focus for 2025 and our key achievements. Our focus for 2025 is within three areas. First, we have initiated clinical studies, our FDA process, and then also preparation for market launch in the US. And step by step, we have really moved from research validation through product development, human factor validation to now be advancing into the clinical trials on preterm born babies in Sweden. And we began the year of 2025 initiating our first clinical pilot study in Sweden, following an approval from Swedish authorities. And this was the very first study that we have done on preterm born infants. We're very happy that we were able to get an ethical approval from the Swedish authorities to start it. And this study evaluates the safety and performance of Neola in preterm born babies. In addition, it's designed to demonstrate both the utility of the product and its compatibility within the clinical environment. The study also serves as a preparatory step to ensure that we capture any potential refinements of the product and the clinical study protocol before entering the clinical study in the US. So this was very much a risk mitigation strategy from our perspective. The patient group ranges from gestational age of 28 weeks and a weight between 1,000 to 3,000 grams. and a total number of 10 preterm-born babies in neonatal intensive care. The study that is ongoing is conducted at Södra Evsborg Hospital in Borås, and the study teams consist of experienced neonatologists and neonatal nurses. And in May, the first baby was successfully included in the now ongoing clinical study on preterm born babies. And this marks the very first time NEOLA has been continuously monitoring the lungs of preterm born baby and also within neonatal intensive care. And later this year, we announced encouraging early finding that this highly vulnerable patient group indicate that it is a very robust safety profile for NEOLA in this very first use on preterm born babies and it's very vulnerable skin. At the same time, the preliminary findings indicate variations in the data that provide valuable insights for us for further optimization of NEOLA before progressing to the US clinical study. Overall, the process of the clinical study protocol for each enrolled baby has worked according to plan, and we now only have one more baby remaining to be enrolled. And then we will summarize and communicate key insights from the full study once all enrolled babies have completed the study and the data has been analyzed and the final full results are available. Going back to finance, during the first half year of 2025, we completed our directed share issue of approximately 20 million kroners, securing financing ahead of the ongoing clinical study start, and also strengthening our shareholder base with our first institutional investors, Adrigo and Cicero, alongside support from our existing shareholders. During the year, we are also especially pleased to have signed an agreement with our first US clinical study site, the prominent neonatal intensive care unit at Children's Regional Hospitals in New Jersey that we visited during Q4. Together with the IRB approval, so we have approval from the institutional review board at the hospital, this is really a key regulatory milestone that enables the initiation of the US clinical study on preterm born babies when we decided the timing is right. And we're very honored to collaborate with Dr. Vinet Bhandari, the principal investigator of this study. He is globally recognized key opinion leader in neonatology. He's also on the board of directors for the U.S. Neonatology Association. And his leadership really adds significant credibility and momentum to this very strategically important study site. 2025 has also marked a record year for the company's intellectual property strategy with seven new patents granted within five different patent families across our key markets, Europe, China, and the US. And with these seven patents, Neola Medical continues to systematically strengthen our intellectual property base behind our core technology, our measurement methods that support both our current device, but also future clinical applications, and also importantly, our disposable components, which is a key part of our revenue model. So our IP portfolio is now one of our most strategically important assets. And as Neola Medical has now entered the clinical phase, we reinforced the leadership team with two recruitments, first a clinical director and then a director of disposable products development. And these roles really add expertise in clinical strategy, as well as developing disposable medical products for daily clinical use and that full scale mass production. as the disposable components are very central to our business model and future recurrent revenues, we have decided to put real emphasis on the disposable probes as of 2026. And with that, I hand over to talk numbers to CFO David Folkesson.

Thank you, Hanna. As you can see, this year has progressed in line with the previous periods, and we keep focus on our costs being on an efficient level. And as we have discussed in this and the previous reports, we're now focusing on the clinical validation phase for NEOLA with preparations and executions ongoing and for the coming studies. This, as you can see, resulted in this year's cost being slightly lower than last year as the need for external resources has decreased as we enter this clinical phase of clinical validation. We try to continue to keep the financial focus on this path towards clinical validation. The clinical validation coming quarters will be a cost-driving activity The ongoing study in Sweden that we started during 2025 is not as expensive as the planned international studies will be. We can also see that the burn rate for the company has been in line with previous year, slightly lower due to the decreased need for external consultants as we progress to the clinical validation phase for the time being. And if We go on to the next slide, Hanna. There hasn't been any major changes in the shareholders table. We feel very grateful for this and thank our current owner for the support and hope to continue that support. Thank you.

Thank you for that, David. Please do continue to follow up. This is our financial calendar. Next report will be released in May, and you also have our annual report being released in April. With that, I thank everyone for listening to the presentation today and also open up for questions.

Yes, thank you very much, Hanna and David. I thought I'd begin with your additions to the IP portfolio. There's been five new patent grants here during the quarter, both in the US and China. You're patented now across all your target markets. Could you give us a little feel towards how your timeline is currently towards commercialization?

Well, we're now very much in the preparatory step for commercialization. going to this clinical phase that we're in. Of course, we're now really planning for commercialization. Our number one market is the US, and we're as narrow to say the US and top 10 children's hospital that we have continuously evaluated. With those 10 hospitals, we're building very tight relationships with the key leaders of the neonatology departments. Within our industry, it's very important to work with the right key opinion leaders at the right hospitals. But also, it might sound like a small market with just top 10 children's hospital in the US. However, we're talking about 800 relevant beds for Neola in just those clinics. So our strategy is very much a niche. We're going super targeted. And we, as you know, we have continuously worked on really building those key opinion leader relationships for many years now. And we could start seeing the effect of that. But we have a lot of more work to be done in the US.

But as it stands right now, how comfortable are you in the preparations that you've made so far in the US market?

I think we're in a good place. It's quite uncommon for European companies to be so integrated in this niche market as we are in the US. A few years back, we started a subsidiary based in Palo Alto, and that has been immensely helpful for us as we have an American base and we also act as an American company when we are on the US market. Now, the next preparatory steps will be to evaluate how quickly to scale in the U.S. As you know, we're very cost focused and we're talking about a few sales reps that will be placed on the U.S. market as soon as we get positive indications from the FDA on our application to be granted approval.

And I assume then that you're moving towards the U.S. then first during your commercialization. But how far away are your other target markets?

Well, our second target market after the US is Europe. We're in parallel preparing an application for CE Mark for the European markets. Our key focus is the Nordics, where we have relationships, also knowing that our technology and products comes and has been developed of neonatologists from Lund University Hospital. And then also using our collaborations with the most prominent children's hospital in Ireland. So Nordics, Ireland, and also France with a few key selected hospitals in Paris is our very much next step. And also here, we have a very targeted approach. We have matured to work with the best key opinion leaders in Europe for many years now, making sure that we have their input and support. already from a clinical research phase. So in the early 2020s, we sold a research system, a research device to this Irish hospital in order for them to start their own, completely from the company, independent clinical studies. And that is the type of activities that you will see from us moving forward, that we're supporting these key researchers to do their own independent evaluation of NEOLA so that it will then be successfully implemented in their clinics.

Let's talk about studies then. In the pilot study that you have initiated, the preliminary findings have shown robustness, but you need to optimize the study a little bit and thus you have a revised timeline. I was curious if you could elaborate on all these three points. What are the preliminary findings? What sort of robustness are you reading out of it? What needs to be optimized and what is the new timeline?

Great questions, and I'm sure that these are really key questions that the investors want to dig into more in detail. So the study is ongoing, so we're still remaining one patient before we can really gather the full data set, analyze the data, and come back with a revised timeline. But I would like to start with saying the reason that we did this clinical pilot study in Sweden before the US study was really risk mitigation to make sure that we could find every single thing that could be optimized before going to the US. Because as we're talking about very advanced medical device in intensive care, it is very difficult to, after a regulatory approval, make any type of changes. And then we have put some pride in to always have a very transparent communication with the market. And that is the reason why when we saw that we had some variations in the data that we needed to understand better and we could see that it's clear that we would do some optimization in the product before going to the US, we wanted to communicate that to the market. So it's more of a signal of our transparency and we will make sure to communicate full results and the implications of the timeline as soon as possible when all babies have been enrolled in the study.

Indeed, and if we turn to the chat, Gustav asks when you expect the last patient to be enrolled and when you can communicate these key insights.

Yes, it's always hard in the clinical setting to know exactly when the patient will be enrolled. If I would take a guess, it will be in the first quarter of 2026.

And do you aim to do similar studies in the US as you continue to prepare for commercialization? If so, what do you expect to take with you from this study?

So for this study, it was the very first study that we did on preterm born infants. So we have learned so much about skin integrity and we're very happy to see a robust safety profile on these babies because that is safety is the key concern of the FDA, but also of the clinicians for adoption. So safety is a very important factor. And then an FDA approval will require a US-based clinical study on safety that we know from previous conversations with the FDA.

And if we turn our attention then to CFO David Folkeson, I have some questions regarding the financial state of the company. You're exiting or you're entering rather 2026 with a cash reserve of 16 million SEK. How would you currently describe the financial stability overall of the company?

Yeah, money is always on the table for development companies, pre-revenue. The board of directors keep a focus on this. And once we have something to communicate for financing, we will communicate it. But the board of directors are very aware of the situation.

Gustav asks in the chat, what is your view of cost development during 2026 directly compared to 2025?

It's very cost driven by clinical studies. And when the clinical study abroad starts, that study will be more costly than the ones we've done in Sweden. So that's a cost driving activity once it started. Otherwise, we can expect the cost being slightly lower than this year for the ongoing activities or the ongoing business.

What is driving the lower costs otherwise?

slightly less external resources going to a lower level than this year.

Thank you very much, David Folkesson. Hanna, I return back to you as we step into 2026. What are some of the most important milestones that investors should look forward to?

Well, now I'm sure that you as well as I want to see a finalised clinical pilot study in Sweden. And with that, to be able to analyze the full data of that pilot study, understand how that impacts our timeline for the US clinical study and ultimately also then our roadmap to market launch.

Looking forward to it. Hanna Sjöström, CEO of Neola Medical. Thank you very much for being here, presenting and answering our questions.

Thank you so much.