Neola Medical AB (publ)

This morning, Neola Medical has published a report for the second quarter of 2026. And joining us here in the digital studio, I have the company's CEO, Hanna Sjöström. Welcome.

Thank you so much.

You will give a presentation of the quarter's development and then I'll return to ask some questions. But before I do that, I would like to also remind our viewers that they can ask their questions in the live chat during this broadcast. So, Hanna, go ahead.

HELLO EVERYONE AND WELCOME TO NIOLA MEDICAL'S PRESENTATION OF OUR SECOND QUARTER FOR 2026. I'M HANNA SCHYSTROM CEO OF NIOLA MEDICAL AND I'M JOINED TODAY BY OUR CFO DAVID FOLKESSON. Now, the second quarter represents an important step forward for Neola Medical. We have completed our first clinical pilot study in our intended patient population, preterm born babies. We have strengthened our financing and based on the clinical and preclinical evidence generated, sharpened the focus of Neola towards continuous lung monitoring with the detection of potentially life threatening lung collapse. So today I will first take you through the key developments and our strategic direction, and then I will conclude together with David with the financial perspective and take your questions. Now, before we begin, I would like to remind you that today's presentation include forward looking statements related to our strategy, market opportunity and development plans. So these are naturally subject to risk and uncertainties, including regulatory and clinical development risks. And you can read more about these risks on our website. With that, over to our presentation. for today. So there are three developments I would like to particularly highlight from the quarter. First, we reported positive safety results from our first clinical pilot study with Neola in preterm born babies in Sweden. And this study really confirmed a favorable safety profile and provided important clinical insights for continued development. Second, we completed the rights issue in June. It was subscribed to approximately 70% and raised approximately 32.5 million SEK in order to support our clinical, regulatory, and market preparation activities. And third, we sharpened our strategic focus. So based on the clinical pilot and our preclinical work, lung collapse detection has emerged as the key clinical capability for NEOLA and really the key benefit for the patients. So together these three milestones provide a stronger foundation for the next phase of development. Neola Medical was founded in 2016 based on advanced technology with a very strong Swedish heritage. So today we're headquartered in Lund with an office in the US and Neola Medical has been listed on Nasdaq First North's gross market since 2020. And we're developing Neola Neonatal Lung Analyzer as a medical device for continuous lung monitoring with an instant detection of potentially life threatening lung collapse in the neonatal intensive care. Our ambition is to bring a completely new type of information to clinicians caring for some of the most vulnerable patients. Neola is designed to enable continuous lung monitoring and an instant detection of potentially life-threatening lung collapse, a very serious condition for these babies. The aim is to provide clinicians with information that can support more proactive care. And ultimately, the clinical ambition is very straightforward. So it's earlier information, faster intervention, and the potential for improved outcomes for premature babies. And this is the value proposition that now guides our continuous product development. And this slide also illustrates the clinical problem we're addressing. So when a preterm born baby develops a serious lung complications such as pneumothorax, a lung collapse, time to action is really critical. So today clinicians may need to rely on diagnostic methods such as chest x-ray where there can be suspicion of lung collapse. but it takes very long time to get a confirmed results. So our ambition with NEOLA is fundamentally different. So by monitoring the lungs continuously, the clinician would receive information about a significant change within seconds rather than waiting for that intermittent examination. So that difference in time is really at heart at the clinical need that we're addressing. And moving forward to the business model. So the business model is designed around three revenue streams. First, you have the sales of the Neola monitoring units. Second, the recurrent sales from disposable probes, which are changed daily on the baby. And then third, we have service agreements associated with the installed device base. and that disposable component is particularly important because it creates recurrent revenues as the number of installed systems, devices and monitor patients grows. Our technology is supported by an extensive intellectual property portfolio. So we currently have eight patent families covering the major assets from the platform across the medical application, the device itself and the disposables. And the objective is not only to protect the current product, but also strengthen our competitive position and create opportunities for future innovation and potentially additional patient groups. Intellectual property therefore remains as a very important part of the long-term value of the Neola platform. The underlying clinical need is very substantial. So, prematurity remains a major global health challenge and respiratory failure is really that leading cause of death for preterm born babies. These are also patients where serious respiratory complications can have lifelong consequences. So for Neola Medical, this really reinforces why early detection matters. So the opportunity is not simply to introduce another monitoring device to the neonatal intensive care unit. It is really to provide information that is currently missing at a point where earlier intervention may really significantly affect clinical outcomes. So current monitoring methods, as you see here on the slide, that are used to assess the lungs have important roles, but also clear limitations. So chest X-ray, ultrasound and blood sampling, for example, provides different type of information, but they're intermittent, they're invasive, they're slow, or they involve radiation. And pulse oximetry, which is continuously available, measures oxygen saturation, but does not directly monitor what is happening inside of the lungs. So NEOLA is being developed to combine those several characteristics that are currently difficult to obtain together. So continuous monitoring, real-time information, non-invasive measurement and importantly no ionizing radiation. So this is the differentiated positioning we are working to establish. And in neonatal intensive care, deterioration can happen very quickly. This is particularly true in serious complications such as the pneumothorax, a lung collapse. And the purpose of continuous lung monitoring is therefore not simply to generate more data, it's really to provide clinically relevant information earlier when the care team still has the opportunity to act on it. And this is why we believe that timing is so central for the clinical value of NEOLA. And as you can see here on the screen, mortality from lung collapse is very high, especially for the babies on mechanical ventilation. So we have a large potential addressable market worldwide and there is a growth in preterm birth and also an increase in the number of neonatal intensive care clinics around the world. There is definitely a large medical need for better neonatal care that also translates into a high demand for technology innovation. And especially US is an attractive market opportunity due to the particular high rate of preterm birth in the US. with now more than 35,600 beds in neonatal intensive care units in the country. And within the US, our commercial opportunity is highly targeted. So we're not everywhere. We are in the places that really matters. So this slide really highlights the leading children's hospital with large neonatal intensive care units that represent an attractive potential pilot and early adopter sites. So these institutions combine large patient volumes with clinical expertise and experience in evaluating new neonatal technologies. So our initial commercial focus is therefore not the entire US hospital market, but really a focus group of leading neonatal intensive care units where the clinical need, the patient volumes and the capacity to adopt new technology are at its strongest. Clinical value is naturally the first requirement for adoption of the device, but also the economic case is very important. So based on our previous market research, potential areas of financial value include reducing manual observation time for the nurses, reducing the number of blood gas samples and chest x-ray, and also reducing length of stay in the very expensive neonatal intensive care unit. So for hospitals even a relatively small improvement in length of stay can have meaningful economic implications because neonatal intensive care is highly resource intensive and our continued market work therefore evaluates both the clinical value proposition and the financial value NIOLA could create for healthcare providers. So bringing this back to the first half of 2026, we have progressed according to four important areas. So clinically, we have completed our first clinical pilot study in preterm born babies and confirmed a favorable safety profile. Also from an IP perspective, so intellectual property wise, we received a new US patent for optical noise reduction, which has also been granted in China and is pending in Europe. Statistically, we sharpened our primary application towards lung collapse detection with pneumothorax, so lung collapse, as an important focus for us moving forward. And financially, the rights issue raised approximately 32.5 million SEK to support continued clinical validation, regulatory activities, and market preparation. So these developments now lead directly into the development path ahead. And the next phase is structured around four major steps. So during 2026, we continue preclinical validation together with algorithm and hardware refinement for lung collapse detection. In parallel, we continue our FDA regulatory interactions during both 2026 and 2027 with the objective to align the US regulatory pathway and clinical study protocol. Our current target is to start the US clinical study around mid-2027. Importantly, that remains subject to regulatory feedback and final study design. So following the completion of the clinical program, the next major step would be submission to the US market authorization, the FDA, while commercial preparations continue in parallel. And with that development perspective, David, over to you for the financial section.

Thank you, Hanna. Start looking with the second quarter, the operating result amounted to minus 3.7 million compared to minus 3 million corresponding period last year. mainly due to investments in personnel and costs related to clinical and regulatory progression. This period's cash flow was minus 5.9 compared to minus 6.2 million last last year depending on changes in the liquidity. For the first half year of 2026 the operating result was minus 7.3 compared to minus 5.7 and as I said before this is due to investment and consultants working with our clinical trials and regulatory progression. Cash flow for the first six months amounted to minus 12.1 compared to last year's seven. The big change from the period in 2025 is that we made the share issue in March 2025, while the funds from our last capital raise landed in our account in July 2026. There's liquidity coming in the third quarter. Looking at the other parameters, we can see that the monthly burn rate was around 2.0 million. Last year was 1.8. And that is in line with the plan of regulatory progression and further clinical work. We do expect the burn rate to increase as the clinical programme and regulatory development accelerates in the coming quarters. looking at the equity ratio of 93 remain free of interest bearing debts. And overall, our financial management remains focused on supporting the key value, which is creating development activities while maintaining strict cost awareness. Looking at the next slide, you can see that On the left, you can see the shareholder data before a rights issue. And on the right, you can see the shareholder list after the rights issue. And as always, we appreciate the continued support from both existing and, as you can see on the right side, new shareholders through this round of financing. Yeah, this share issue has strengthened our ability to continue executing development plans, as Hanna's program said before. And with that, I'll hand it back to you, Hanna.

Thank you so much, David. So let me conclude by summarizing here why we believe that Neola Medical represents an interesting opportunity. So we really address a clear unmet clinical need in the neonatal intensive care where faster detection of those serious lung complications could really make an important difference. We also have patented technology that is designed specifically for continuous lung monitoring. and we're targeting a growing addressable market, especially within the US as our primary focus. And importantly, our business model really combines that Neola device sales with recurrent disposable revenues and service agreement. So we have a very experienced team, as you can see here, making progress together in the strong clinical development or regulatory work and also a very strong international network. So during the first half year of 2026, we really strengthened that clinical foundation. We sharpened our product focus and we secured additional financing for the next phase. So I think that overall we're in a very good position in the company following these first six months of 2026. So with that, thank you so much for listening and for your continued interest in Neola Medical. We have our next report coming up here the 18th of November and do also welcome you all to join us for the annual general meeting next year, highlighting 27th of May. So with that, we open up for your questions.

Thank you very much, Hanna and David. Startinging off then with the data from the clinical pilot study, you could report positive data with favorable safety profile for Neola. Can you tell us more about these results? Just how positive were they?

So I would say that it's an important transition that we made from really demonstrating that Neola can be used safely in our intended patient population. Precisely where the technology can create the greatest clinical value has really been highlighted in the study as well. So the confirmed favorable safety profile has generated very important clinical learnings. And combining that with our preclinical work, we have been able to really sharpen our focus towards continuous monitoring and the detection of potentially life-threatening lung collapse. So I think that these are really strong results and learnings coming out of the clinical study. And yes, overall, we are very happy that we did the pilot study in preparation for our US study.

Do you have an indication of how this data compares to peers?

Well, so in this study, safety was really the primary objective and the outcome was very encouraging. So we demonstrated a favorable safety profile across the study population, which is very important as we did it in very low birth weight preterm born babies. So, down to a thousand grams. And this was really the first time that we used NEOLA in its intended patient population in a neonatal intensive care setting. So, establishing safety at this stage was extremely important milestone for us. I would not make a direct comparison with PEARS because there is currently no direct comparable technology providing the same results of continuous lung monitoring. So instead I would say that the important point for us now is really that the results support taking NEOLA into the next stage of development.

And patient recruiting that finished in March and you were able to report these results in April already. Can we expect more readouts from the data moving forward in this study specifically?

Well, the results communicated in April really represented the final headline results from this pilot study. So the value of the study now goes primarily into the next phase, which is about optimizing NEOLA, refining the clinical application and informing the design of our subsequent validation and our US clinical work. So rather than expecting another major efficiency readout from these 10 patients, investors should really look for how the learnings from the study now translate into the next generation of clinical evidence.

And you're also sharpening Niola's focus towards detection of lung collapse. Was this an unexpected turn for you heading into this pilot study?

It was not based on one individual data point, this decision. It was really a combination of what we learned from both the clinical pilot study and the preclinical validation work that we did in parallel. So the underlying NEOLA technology has always been designed for continuously monitoring the changes in the lungs. But what became very clear for us is that we now have a unique ability to add a particularly high clinical value. So identifying potentially life-threatening changes such as a lung collapse earlier than today's intermittent monitoring methods such as chest x-ray. So I would call this an evolution and a sharpening of our strategy rather than a change of direction. We are really building on the same core technology. It was not a surprise to us, but very pleasantly development to see that we could add so much clinical value to this patient group and the product. So the next phase now for us involves further algorithm and hardware refinement, and we're in that process right now to add this to the specific clinical detection of lung collapse.

I believe Gustav's question in the chat relates to this. Could you elaborate more on what adjustments you've made to the NIOLA device?

Yes, for us, it's been about sharpening the algorithm detection. So we're now in development of a specific lung collapse detection algorithm, which we believe will add a lot of value to the product. So it's mainly related to software development and algorithms sharpening.

Do you believe the narrowed focus here will also affect the regulatory and commercial path?

Yes, I think that it sharpens and really strengthens our regulatory path in a way that we now give the FDA a very clear clinical value proposition. So this is of course important in our ongoing conversations with the FDAs that we're having for our clinical study aimed at 2027.

Could you walk us through the regulatory process where you are now to potential market approval in the United States?

Absolutely. So during 2026, our focus is continued preclinical validation and further refinements for that lung collapse detection, which is then mainly focused on algorithm development and validation of the algorithm. And in parallel, we're continuing our regulatory interactions with the FDA that we have ongoing to align the regulatory pathway and also the clinical study design. So subject to that feedback from the FDA on the final study design, our current target is to initiate the US clinical study around mid-2027. And then the results from that study would then be an important part of the documentation supporting our FDA submission for market authorization.

Gustav has asked, do you currently have a dialogue with the FDA regarding the upcoming studies? But you sort of answered that. So instead, I'll ask, is it going according to plan, these dialogues?

I would say that we will comment on the dialogue with the FDA once once we have a clear understanding of where we're at. But I would say overall, the FDA has a very strong children's team that we have been working together with for many years now. They have a very good understanding of where we are and now also are very interested overall in what we're trying to achieve with lung collapse detection. So I remain positive in the ongoing discussions with the FDA.

And with these discussions taking place and just having come from a pilot clinical study, what do you believe will be the greatest challenge in the regulatory process in the United States?

I would say that overall, it's very important for us to understand the prerequisites. So to always making sure that we're in line with the FDA is important in order to follow our study track.

Considering that the NIOLA turns towards a very specific form of patient, is the recruitment a challenge?

say that when you have a preterm born baby, many parents are very interested in anything that can really support the early detection of severe complications. So the experience that we have from the clinical pilot study in Sweden showed that there is a major parental interest in any innovation that can really strengthen the the ability for their children to thrive. So I would say that that's really the focus point of the parents. And also what we're looking here are that we're going to do a study on very large clinical sites in the US, which also helps in order to get a fast completion of a study.

Moving on to finance then. You managed to raise SEK 32.5 million in a rights issue. The subscription rate here was 70%. How do you interpret interest from your shareholders supporting the current path of Neolot?

Well, we very appreciate of the support from both existing shareholders and also new investors. So for with raising 32.5 million SEK in the current capital market really provides a very important support for the next development phase for us. So importantly, now we will use this capital with discipline and we will focus on activities that create meaningful value. clinical, preclinical validation, the regulatory process and also preparation for future commercialization.

And timeframe, how long do you expect this new capital to last?

So David, do you want to take that one?

Yeah, sure. As always, we never provide any specific cash runway forecast going forward. But as Hanna said, we now landed this capital raise and the proceeds from this will support the development phase with preclinical and clinical validation and the regulatory pathway together with the FDA. So the answer is we don't provide a specific cash runway for cost. But we're very cautious with the what the clinical program will require in the resources forward, and financing is always on the table and a big part of our strategic planning as we go forward with the clinical development program.

I believe, David, that you touched on this during the presentation, the cost developments, and Gustav asks what we can expect from the cost development in the upcoming quarters.

That is also a going forward question, but it goes for sure that the cost will increase, the expenditure will increase due to clinical and preclinical validation programs. How much is nothing that we can communicate right now, but an increase is inevitable.

And returning to you, Hanna, with the first half of 2026 done, moving on to the second half, what should investors look out for when they follow Niola?

Well, the main focus for the remainder of the 2026 year here is execution towards the next clinical phase. So I would say that three areas are particularly important. Continued preclinical validation of lung collapse detection, progress in our FDA regulatory interactions, and development of the clinical strategy and study design for the US market. And I would also like to emphasize the broader strategic picture. So we have now moved from a much more focused clinical application. We have also strengthened the financing and we have a very clear development path. So the work during the remainder of the year is really about converting that sharp focus into evidence and regulatory foundation that is required for the next major clinical step.

Hanna Sjöström and David Folkesson. Thank you very much for being here presenting and answering our questions.

Thank you so much for having us.