Joacim Holter
Welcome to our Q2 presentation for 2026. Before I jump into it, I want to kind of point out the small superstar shown on the screen.
For those of you who were here last year, you might remember that I informed that I had implanted one of our veterinary prototypes in my upper arm. There were two reasons for doing that.
Based on the information we had, I considered it to be a safe move to do. To implant something in my body is obviously something I need to consider before I do it.
The second thing was the need and interest I had, and also the organization had, of experiencing our product in real life. One thing is, of course, to read PowerPoint presentations and laboratory presentations, etc., but to have it in the body, to feel how it is, to notice whether it moves or not, to notice whether it affects the daily life, and of course, also the communication part.
Because we are on a journey that is quite complex, and we are set out to measure body analytes inside the body. That is not a straightforward operation.
This also consists of electronics, radio communication, material choices, etc. The output from this experiment I had the last year was very interesting and relevant for me, personally, but also in a high degree the company and our developers.
What I'm showing you here is, of course, it's a picture of our implant, but it's first and foremost an indication of the move we have done throughout the last year, and especially, of course, in the second quarter of 2026. Our highlights for the quarter includes the fact that we have strongly increased our real-world evidence for use of the implant.
We have obtained and gained quite a lot of regulatory clarity. In addition, we have tweaked the company into a high degree of operational focus, which also affects our expected runway.
The three takeaways here today is, first and foremost, our real-world evidence. Throughout the second quarter of 2026, we have been able to show three implants implanted in dogs for 6 months.
The last time I was presenting the Q1, we had a 12-month duration of one implant. Today, we have a 6-month implantation of three implants, which is a significant progress.
Further, we have moved on the regulatory path from a conceptual first-in-human study—we have decided not to do that and rather go directly into our pivotal CE study. That requires quite a lot of more documentation than what was planned for the first-in-human study, but we are progressing, and we are happy to inform you about that in this presentation.
Also, some of you might know that we in Q1 decided to wind down our operations in Germany and move all of our operations to Bergen. That has led to a reduced cost base, and the consolidation of our manufacturing in Bergen is ongoing, and it looks obviously promising.
Throughout the second quarter, we have materially strengthened our in vivo evidence. In vivo means implanted in live tissue.
Our dog study evidence based on real-world implantation has been analyzed in terms of the independent tissue analysis and device signal learning that is very promising going forward related to the question of how long we actually can keep our implant in the body. On the first picture, you can see Truls, the dog Truls.
He's a diabetic dog. He's 13 years old.
He's blind because of his diabetes, and I mentioned that our implant is a superstar, he is our real-world superstar. He was the first dog with a 6-month implantation.
That provided us with the first valuable data in terms of the communication, in terms of the fact that we don't affect the tissue in a degree that is surprising, and also the fact that we could read out relevant data. As a consequence of that, the fact that we were able to provide continuous data from his glucose levels to the veterinary, it also provided a way more precise and improved clinical treatment of the dog Truls.
From the start, where he were quite affected by his diabetes, to the end of the 6-month period, we were able to play a part in making his daily life better, and then potentially also making his owner's daily life much better. That is an invaluable learning that we cannot show on the data sheets, but that's what this is all about: the fact that we are on a journey where we want to make life better for people and animals with diabetes.
This is the slide where I would expect there to be quite a lot of questions related to our clinical progress in terms of study, our regulatory progress. I mentioned earlier that we have moved from our original plan, which was to have a conceptual and quite small first-in-human study.
Due to the fact that we had a pushback on the regulatory application we did in the first quarter of 2026, we have reconsidered our regulatory plan, and we have also redrafted and outlined an overall clinical regulatory plan, where we have decided to go directly into the pivotal CE study that is meant to give us the regulatory feedback that provides us the possibility to get the CE mark. This move also includes that the work and the preparation we are doing is quite more significant than what we originally did.
We are working to get our submission ready, and to do that, we are depending on having manufacturing control to verify our manufacturing, to ensure that we have documentation in terms of quality, in terms of materials, in terms of the production line as is. This is several work streams going in parallel that is directly affected by the setup of the manufacturing that we are doing in Bergen.
There is a strong link between our regulatory preparations and our manufacturing preparations in Bergen. The regulatory timeline now is driven by readiness of the evidence package, not necessarily the earliest possible filing date, and for us there's a significant difference in that.
We don't want to chase the earliest possible date. The takeaway from this slide is that to get to the regulatory submission, we need to ensure that we have controlled manufacturing.
I'm probably going to repeat the phrase 'controlled manufacturing' a few times just to make that very clear. Controlled manufacturing does not mean the ability to manufacture.
Controlled manufacturing means that we have full control over all elements in the manufacturing, both in terms of documentation and in terms of execution. That is imperative to be able to go forward with the pivotal study.
That is one of the reasons why we have decided to move our production from Germany, the UK, and consolidate and centralize it here in Bergen. This is partly a response to the regulatory feedback, but it also provides us with a lower cost base and an increased engineering focus and an increased execution focus.
Traditionally, our manufacturing and also our development has been centralized around science on different locations. That made sense up to end of last year, I would say.
It made sense to be organized in this way. From a operational point of view, to restructure so that we are able to set up the controlled manufacturing at the same location where we have quality control, where we have all our engineers, makes more sense to have it spread.
This is a shift towards a much more engineering-led execution of our program. Right now, we have consolidated the operating model, where we have the equipment for manufacturing already in Bergen.
However, to set up the manufacturing is more than moving the equipment. Now we are in the final phase of the move of the manufacturing, which is then all about to gain control in terms of the documentation we need to be able to produce the same implant every time without failures.
This is a strengthening of our overall organization, while we still keep the UK entity when it comes to the chemistry development. It leads to a lower cost base.
It leads to an integrated execution. As Petter is going to tell us quite soon, it also affects our runway for the upcoming quarters.
All in all, what I have presented now represent a stronger foundation for our next phase. Q2 isolated definitely strengthen Lifecare's evidence base, the regulatory planning, and the ability to execute with capital discipline.
We have a lower cost base. We have an integrated execution.
We have a way better planning basis for our regulatory way forward. I deliberately am not stating any dates related to the filing of the regulatory application.
The reason for that—I feel a need to explain that—is that if I were going to state the date today, it would have been artificially. Because we have to ensure that we control the manufacturing processes before we can say with certainty, this is our filing date.
I very much look forward to come back to you guys and tell you when that filing date is. I know that you understand that we need to ensure that these prerequisites are in place before we actually point it out.
This is not any hidden message related to technology, right? Because the evidence for the technology is increasingly improved, and it's increasing quarter by quarter.
We're talking about getting the production into a controlled manufacturing based on our now enhanced, focused organization with the consolidated manufacturing and a clearer regulatory plan. I think I'm going to stop that part of the presentation there and leave it to Petter to finally be able to inform you about some numbers that are looking better than usual, not at least it is showing the effect of the consolidation of our manufacturing and operations.
Petter Nielsen
Good morning, and, oh, thank you for participating in this presentation. I will go through our numbers for the quarter and first half of the year.
Yes, we are still a development company, we do have some limited revenue, but that's only related to government grants. In Norwegian, these are SkatteFUNN that we recognize.
We had about NOK 250,000 in the quarter. We have, as CEO Joacim has been talking about, a cost base that has been significantly reduced.
Our operating expenses in the quarter were reduced even further from Q1, which also had a reduction. We are now, first half of 2026, we are 2 million lower than same period in 2025.
We did have a impairment adjustment in Q1 2026 of 12 million. If we take that into account, we have a cost base that's really 14 million lower than same period last year.
As you see, our cost base has been reduced in basically all the different categories, of course. Employee, impairment obviously, and other operating expenses.
For Q1 sorry, Q2, we had an operating expense or loss of 10.6 million, while it in Q2 2025 was 22 million. In Q1, we had 31 million in negative profit, operating profit, there is a significant reduction in our cost base.
Part of this is related to the winding down of our German entity that we started in Q1. We do have some further effects of that into Q2, but we do not yet have the full effects of the wind-down and the following insolvency in the German entity.
We will have the full effects of those items in Q3 and going forward, we will continue to have a lower cost base and also a bit lower than what we are showing in Q2. There are some particular items in Q2 that are worth mentioning.
We started a winding down of our German entity in Q1, but in late Q2, the process moved on to a formal insolvency process. That also means that as of end of Q2, we have deconsolidated the German entity from the group.
We do have it included, obviously, in our P&L, but in terms of our balance sheet, it has now been deconsolidated, and it's not longer any part of the group figures. This also led to a gain in Q2 of 2 million through the deconsolidation of that entity following the loss of control.
Also, here we are showing the operating profits, but if we go one step further, we would see that we had a quite high financial income in Q2, and that's related to fair value adjustments of warrants. Those were exercised in the second part of the tranche was exercised in June, and it gave us a gain, which in total gives us a profit in Q2 of 4.5 million.
Comparatives for last year were 13.6 in a loss. First half of the year, we had a loss of 32 million compared to the 33.9 last year.
We do see effects of the changes that we have been implementing in our organization. The reduction of costs is quite significant, and we will have a further cost reduction also going forward.
Moving to our cash flow, we started the quarter at 26 million, and of course, that was following the rights issue and the first set of warrants that were exercised in Q1. Starting at 26 million, and then we had a new capital raise in June related to the second series of the warrants, which gave us 25 million in net proceeds.
We continue, of course, with our R&D activities, which were at around 3 million in Q2, and other OPEX of 7, which then also includes our own salary for employees within Lifecare, and of course, a large part of those are working actively on our research and development. We have some effects of timing effects related to accounts payables and receivables, and we are ending the quarter at 37 million, which is a good standing at end of Q2.
We do expect that the current cash balance we have, given our current plans, will provide us runway in through to Q2 2027. We are in a considerably better financial position than what has been the case over some time.
That, I guess, is the summary of where we are on the financial side. Positive numbers and increasing control and reduction of cost base, which we will also see going forward.
I'll hand back to you, Joacim, to give us more thoughts on what's coming up.
Joacim Holter
Thank you very much, Petter. Our chain of execution right now is built on years of experience.
It's built on the strong and materially increased real-world evidence. That evidence provides us learning into our product, and the product provides us learnings and enhances to be able to do controlled production that, consequently, will lead to a regulatory filing and then, finally, to execute on the pivotal CE study so that we are getting regulatory authorization to be able to go into the human market.
The processes here are, in quite an extent, parallel, and the fact that we are talking about regulatory preparations is not an indication that we have somebody sitting at the desk and writing down operations and writing applications. On the contrary, the most important thing we are doing going forward is to complete the manufacturing establishment in Bergen with documentation and controlled processes that leads over to prepare for the clinical investigation based on a submission-ready package.
In parallel with this, we will continue to apply the learnings that we have gained from the veterinary study. To be clear, the veterinary study is ongoing; it is not finalized.
We are still doing study with dogs in a 6-month 6-month durations. The real-world evidence will give us enhanced information on the implant performance, the signal interpretation, and the future, of course, system configurations.
Just as important in the upcoming period is the fact that we now have the vessel for our technology. Lifecare's product is basically our technology.
We have the infrastructure ready; we have the implant. The question is: what do we want to measure going forward?
We will increase our focus on expanding our potential monitoring analytes beyond glucose. However, we will, of course, we will stay focused on the first application that will be glucose, no matter how you envision it.
Glucose is the first application for humans, for veterinary use. We will investigate deeper how we can use the basic technology to new applications.
That also then includes that we will increase our focused approach to potential partners going forward, both veterinary and within human medicine. We can do that based on the fact that our current operating plan, as Petter just explained, provides us with an expected runway through Q2 2027.
After Q2, I'm very happy to be able to say that we have a more disciplined cost base, we have consolidated our execution, and we have a pivotal CE focus. Going back to the opening of this presentation, yeah, it was fun last year to tell you that I had implanted the veterinary prototype, but I've got to say that this is even more fun, to actually feel that the company is developing into a solid, disciplined company with a consolidated organization and a disciplined cost base.
We enter the second half of 2022 with 2026 with high expectations, and we look forward to bring our complete technology important steps forward towards both veterinary and human applications, and hopefully, be able to say something more about that at a later point of time. I'm not going to go deeper into it.
It's too easy to start to babble about it. Okay.
It's always fun to be at Vestland på Børs. It's good to have an audience.
It's more intriguing than being at the office and doing an online presentation. However, we are also sending this online.
Our Q2 report is, as always, available for download. Now it's time to open for any questions that you might have in the audience or that is being published on the online portal.
We have 16 minutes for questions, and that might be more than enough time.
Petter Nielsen
Online, unless there's some in the audience first, we can start with those.
The current runway through Q2 of 2027, does that include filing for the CE study?
Joacim Holter
It includes filing, yes.
Filing.
Joacim Holter
Yeah.
Petter Nielsen
Okay. We have a question related to how big are the expenses related to the move of production to Bergen.
Joacim Holter
I don't have a firm number on kind of the exact number on what the cost, but I think we have shown significant savings following the wind-down and later then also insolvency of the German company, that reduced our ongoing costs quite significantly. Obviously, building up organization in Bergen and building up production will increase those costs to some extent.
The total picture is definitely represented by what we see today. We do not expect any significant increases in costs related to the fact that we're setting up manufacturing in Bergen.
That is somewhat captured in the fact that we aim to do a disciplined capital control of the company.
Petter Nielsen
Thank you. Next question is related to the three dogs.
Can you say something with the type of data that we got from the three dogs over these 6 months in terms of precision, quality, and MARD?
Joacim Holter
Yeah. I think it's important to say, first of all, our ambitious project is to take technology—meaning electronics, meaning radio, meaning chemistry—and put it under the skin, in tissue, to monitor the biological changes in the body.
That is not trivial. It is important for me to state, that it's quite common to think that radio and electronics is available off the shelf.
Yes, of course it is. However, you need to configure it to your specific use.
Placing electronics and placing radio underneath the skin is a quite harsh environment. It is affected by live tissue.
It's affected by temperature. It's affected by noise that is in the body.
The data that we are getting out is, first and foremost, the fact that we are increasing our understanding of the drift, of the noise, of the biological influence on the implant we have integrated in or implanted in live tissue. In addition to this, we have a significant increase in glucose-related data.
I specifically define that as glucose-related data because this is influenced by the drift, by the noise, by the biological environment. I think that the easy example is that it's to put our sensor on a lab bench and add glucose and get the result that the glucose is increasing, and then it will decrease when you take out the glucose.
That's easy. It's more complex to do it in the body.
If we rephrase maybe that question and say that does your development show that you can measure glucose? The answer to that is that is definitely yes.
We have done that for years. We have done it in the lab.
We have done it in pigs. We have done it in humans.
We have done it in dogs. Does our development today represent a controlled medical device that can give people with a serious disease specific values that would be accepted by regulatory authorities?
No, it doesn't. That is part of our development.
The development is all about taking a functional technology through manufacturing setup into a regulatory setup to get the authorization needed to be able to give patients highly important information that potentially affects life and death. The technology works.
We have increased our proof on that, and we are very much looking forward to be able to push this through a regulatory trajectory, to put it that way. We are not going to disclose specific data from three dogs.
We need the time to gain data that will ensure that we have a regulatory package that is good enough, and we will not be able to do that before we have the regulatory CE study finalized. I hope that was thorough enough.
Petter Nielsen
Let's hope so. Next question is related to, or a comment that you have previously released that a automated production was in place and, in principle, could start mass production.
What has happened and why are you now behind on this?
Joacim Holter
I'm not sure that I can remember that we have stated that an automated production is in place. We have done quite a lot of preparations towards being able to do an automated production.
We are not at that stage because we have to set up the controlled production. We cannot take our theories and expectations and put them into a computer and get an answer out on the other side.
What has happened is development, and that sounds like a quite strange answer, but what has happened following the information we have provided to the market is development. Also the fact that setting up a controlled production is complex.
We are still working on that, and I think that what we are presenting today is far beyond what we have presented ever before.
Petter Nielsen
Okay. Then we have a quite long question, or I guess several questions in one.
I'll read it up and then let's see if you can remember all the aspects. On performance data, could you share more color on the quantified results behind the materially strengthened glucose-related databases, specifically do you have a timeline in mind for disclosing MARD figures?
Also, how would you respond to observers who feel the process has taken longer than expected? On regulatory clarity, could you elaborate on what clearer pathway means in practice?
If you deliberately don't disclose any specific date, is there a tentative timeline? It would be helpful to understand which manufacturing verification documentation items are still outstanding and what the earliest realistic window looks like for submitting and starting the pivotal study.
Then on cash, given the defined guidance through Q2 2027, could you clarify whether the current cash position is expected to cover regulatory submission, study initiation, both, or neither? It would also be helpful to understand the estimated capital requirements through the pivotal study completion.
Joacim Holter
Okay. I think that I understand all the questions.
I certainly understand the interest to know these things, but I also have kind of built-in kind of protection about providing small amounts of information about essential strategic progress in the company and planning. Obviously, if we disclose our full strategy, that would be relevant for a lot of people, but I don't think it's relevant to have kind of peaks of small parts of the information.
I don't think it's appropriate to go in and kind of provide update on exactly what we're going to use money on in the upcoming time. We are reporting that we have a disciplined financial runway, finance base, that we have a runway through 2027, and also what our focus is right now.
It's to get the manufacturing on a controlled level, including all the documentation needed so that we can move on to the regulatory filing. I don't want to go into a discussion on speculating on when that's going to happen.
I would be the first one who want to inform you about that, but I don't want to do that before I have certainty on it. We all know what happens if I speculate now; most likely, I'm going to miss the target because a speculation is not good enough at this point of time.
As soon as we are able to say something firm about the filing, you can expect that we inform the market about that immediately. That was some of the questions that I did not answer, but at least address.
What did I miss, Petter?
Petter Nielsen
Good question. There was a note to MARD figures, but I think you answered that in a previous question as well.
If you want to elaborate, you could, but I think perhaps that has been answered. The general remark about taking longer than expected, is there something perhaps you could add on there?
Joacim Holter
I want to address the MARD question specifically, because I don't think it's fair to take out parts of our first results and turn that into expectations. That is why we have a regulatory process.
We have to ensure that we get a complete data set before we actually tell specifically how good we are. We have high expectations to ourselves, but if we give out early data that doesn't have a statistical relevance, that would not be appropriate from a development company.
We need to ensure that our communication is based on statistical data and that is firm. Then the next one was the delay.
What kind of delay was that?
Petter Nielsen
In terms of observers who feel that the process has taken longer time, I guess the development process, I guess, is the question.
Joacim Holter
Yeah. We have indicated earlier that we were able to go to market in the veterinary field.
However, we see that there are product configurations that we need to ensure that are better before we actually do that. When I'm talking about product configurations, I'm talking about the placement of the readout, how we ensure that the connectivity is good, etc.
It's not a question about the technology as is. The progress, in general, has been slower than what we could expect some years ago or what we hoped some years ago.
That is part of our development, and I think that for us, it's important to keep focus on spending the capital wisely, being responsible in terms of what we prioritize. I think that we have shown that right now, and we will be able to transfer our manufacturing into regulatory application within a reasonable time, but I'm not prepared to speculate closer into that.
Petter Nielsen
Okay. I think we have addressed the basis for those questions or the questions there.
If we jump ahead to another question: A limited veterinary market launch has been described previously as a near-term priority. Has that timeline and strategy changed, and when do you realistically expect commercial veterinary sales?
Joacim Holter
I think that our focus is first and foremost to ensure manufacturing setup—and I'm repeating myself, I know that—and also to be able to get into the regulatory path. That is our main goal.
A consequence of getting the manufacturing up and running controlled will, of course, affect the timeline towards a veterinary market launch. We have not stated specifically when that will happen, and once again, I don't want to go into those speculations.
I can assure you that as soon as we have something firm also in that field, we will disclose that to the market.
Petter Nielsen
Okay. There's a question about, please explain what Lifecare earned money on in Q2, provide as many details as you can.
I'll just address that. We had some government grants that we recognize revenue on.
We had a technical gain on the deconsolidation of our German entity as we lost control through the insolvency process, and lastly, we had a financial gain related to revaluation of the warrants that were exercised. Of course, we had warrants that were exercised both in March and in June.
It's a technical revaluation of warrants that actually provide us with a gain. It's not any operational items in terms of revenue.
There is a question about verification and validation of devices produced in the new product production facility, the main issues that need to be addressed before submitting to NoMa, and how about the issues like biocompatibility, etc.?
Joacim Holter
There are no issues that needs to be addressed, other than the fact that we have moved the manufacturing capabilities to Bergen, and we are setting up the production. We need to do that in a controlled manner; we need to have full control on documentation.
This is engineering-led execution. There are no specific issues that needs to be addressed in terms of neither the technology nor the production itself.
We have 15 seconds, I see.
Petter Nielsen
Last question is, is CE marking in 2027 still a realistic management target?
Joacim Holter
That's a good question. For every day passing, of course, that gets less realistic.
It's still not unrealistic, but obviously, the closer we get to 2027, the more difficult it is. The question is based on when is our manufacturing controlled enough to be able to have the documentation and hand it over to the regulatory authorities, the submission-ready package.
I'm going to say that I don't have any more time. Oh,
Petter Nielsen
that's good. Thank you.
Joacim Holter
Thank you very much for your attention. Great being here, as always.
Please forward your questions afterwards or at any time. Thank you.
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