Joacim Holter
Thank you for joining Lifecare's quarterly presentation for the first quarter of 2026. Before I go into the details of the quarter and the highlights, I want to emphasize that this has been one of the most eventful and transformative quarters in Lifecare's history.
On the positive side, we have reached several milestones that confirms the maturity of our platform. This includes that we have met the milestone of reproducible implant manufacturing that has provided us with a confirmation on a system-level functionality in vivo, based on stable implant performance beyond 12 weeks in real-life conditions.
We have also reached the milestone of achieving the CE mark for our implant electronics, which obviously is an important regulatory and operational milestone for the platform itself. We have also throughout the quarter had some more challenging developments.
Our first-in-human study application was not approved in its submitted form. Additional documentation and validations are required.
Our Chief Scientific Officer has transitioned into a consultant role, and based on a strategic reassessment, we have also decided to discontinue our German operations. This means that we have unfortunately had to say goodbye to several highly valued colleagues in Germany who have contributed significantly to Lifecare over many years.
However, this transition in the German operations has also resulted in certain accounting effects that you will see from the numbers that we are reporting on today. It's a bit important for me to underline the fact that even though there are accounting effects, they do not have an actual cash effect.
On the contrary, what we see based on the discontinuation of the German entity, we see that we are moving towards a leaner and more scalable operational platform going forward. We also do expect quite high cost reductions.
Rather than reviewing these events in isolation, we have used the period as an opportunity to assess and strengthen both our operational and regulatory strategy. We have initiated important adjustments that we believe will improve the execution, simplify our regulatory strategy, and position Lifecare efficiently for the next phase of development, scale-up, and commercialization.
I want to summarize the operational progress in the first quarter across four main areas, the first being product validation. We have demonstrated that the fully implanted system operates in vivo as designed, based on reproducible implant manufacturing.
We have also seen coherent glucose signal behavior from the raw in vivo data. On the longevity and performance side, we are continuing our study, and we see a stable implant performance beyond 12 weeks under real-life conditions, and this is a performance that is still ongoing.
On the regulatory side, we have met an important inflection point in the quarter. Based on the feedback from NoMa, we have done a broader reassessment of our clinical and regulatory pathway.
We have simplified our strategy towards a single pivotal CE mark study that will lead to execution efficiency and also capital efficiency. On the operational side, we have initiated a transition towards manufacturing in Bergen, including a more centralized and scalable model where we are consolidating our operations in Norway and in the UK.
Taken together, we believe that Q1 marks a transition from feasibility validation towards scalable execution, regulatory progression, and market readiness. One of the most important technical milestones in the quarter has been the demonstration of the fully integrated CGM system that operates in vivo as designed.
We see glucose-related signal behavior that is based on raw in vitro data without calibration or post-processing. This is confirming not only the underlying sensing principle, but also the integrity of the full implant architecture in a wireless living system.
Strategically, we do no longer question whether the system fundamentally works, rather how we optimize performance, execute the regulatory pathway, and scale production in a controlled manner. The longevity study continues to generate very important operational and biological data and has continued to do that throughout the quarter.
We still see stable implant performance, and as mentioned, beyond 12 weeks under real-life conditions. From a strategic perspective, this is highly important.
The long-time durability and predictability over time are obviously critical requirements for any implantable sensor platform. The results we see materially reduce the durability risk ahead of our future human studies, and this obviously strengthened our confidence in the long-term potential of calibration-free glucose monitoring.
We have simplified and also strengthened our regulatory pathway in the quarter. The feedback we've received from NoMa led to a broader reassessment of our overall clinical and regulatory pathway.
We have optimized our overall development pathway going forward by strengthening our regulatory execution. We have engaged LINK Medical as clinical advisors, and in addition initiated advisory interactions with prospective notified bodies.
The main outcome of these actions is that we have simplified the clinical strategy centered around one pivotal CE mark clinical investigation that will then replace our previous two-step approach. This will reduce execution complexity, it will improve our capital efficiency, and it will lead to a direct and more predictable route toward clinical validation and future market entry, as the remaining development focus is increasingly centered on documentation, validation, quality system, and production readiness.
Another important milestone in the quarter is the fact that we have completed the CE marking for our implant electronics under applicable EU directives. This leads to the statement that our veterinary product configuration that contains these electronics is now basically cleared for commercial sales in Europe.
However, we view this strategically. This is first and foremost an important validation of the regulatory quality and manufacturing platform that confirms that the electronics architecture itself meet stringent European safety performance requirements in a production-level configuration.
This has an important significance beyond the veterinary segment itself. The milestone strengthen the broader regulatory foundation for the platform, and it supports our continued development toward future clinical and commercial readiness.
In the quarter, we have executed on a broader transition toward an operating model that is more scalable and integrated. Following the maturation of technology and production processes, we have identified an increased need to bring key capabilities closer together across manufacturing, quality systems, regulatory work, and product development.
We have initiated a transition toward a more centralized operational structure where we are moving our manufacturing activities to Bergen and consolidating our overall operations in Norway and in the UK. The overall objective of this is to improve operational control, reduce complexity, accelerate iteration between development and manufacturing, and also strengthen the platform for scalable clinical and future commercial supply.
Q1 marked an important structural transition for Lifecare. Collectively, the milestones that we achieved during the quarter strengthened the maturity of the platform across our validation, manufacturing, regulatory positioning, and also operational execution.
Our immediate priorities are increasingly centered around execution, where we look forward to finalize the updated regulatory strategy, continue system optimization, and strengthen manufacturing and quality systems ahead of future scale-up. As Q1 marked a structural transition from feasibility validation toward operational execution, regulatory progression, and scalable product realization.
Finally, this slides summarizes how we currently view the pathway forward, following the developments that I've gone through, and also based on the strategic reassessment initiated in the first quarter. I want to emphasize that we are still reassessing parts of the regulatory pathway and the broader operational strategy, including ongoing transition of manufacturing of operational activities toward Bergen.
As a result, we have intentionally moved away from on this slide communicating specific timing milestones at this stage, as we are focusing on establishing a simplified, scalable, execution-focused pathway toward clinical validation and future market entry. We do expect to provide a greater clarity and more specific timing guidance as this work progresses, and our ambition is to communicate a more updated and detailed roadmap in connection with the next quarterly report.
The work completed to date include human proof-of-concept data, longevity and biocompatibility results, reproducible implant manufacturing, and now also a system-level in vivo validation, and this provides a significantly stronger foundation for this next phase. The key enabling factor remaining includes regulatory progression, product readiness, financing, and strategic partnerships, which together will support progression toward clinical validation and future commercialization.
With this, I want to hand over to our new CFO, Petter Nielsen. This is his first quarterly presentation for Lifecare.
We're very happy to have him on board, Petter, please take the stage.
Petter Nielsen
Thank you. As Joacim just mentioned, I am new to the company, those of you who have been following the company for some time will recognize me as a new face.
I joined Lifecare in April as the CFO, and I look forward to working on developing the company and products going forward. Just a brief introduction.
I come professionally from different roles, including both CEO and CFO, but of most relevance for Lifecare, I was previously the CFO of a biotech company, BerGenBio, which IPO'd on the stock exchange in Oslo in 2017. Through that position, I was involved in drug development and multiple clinical trials across the US and Europe.
I am familiar with the space in which Lifecare operates. With that, I hope to be able to contribute to the advancement into the clinic and also the future commercialization of the company.
If we then move on to the profit and loss, as Joacim briefly mentioned, we do have some effects related to the reorganization and strategic reorganization and operational reorganization, which is primarily linked to the wind-down of our German entity. These do hit the Q1 report, and we have, as a consequence of this, recognized a 12 million NOK loss on impairment related to the German wind-down that is ongoing.
It's important to say that these effects do not have a cash flow element. In Q1 2026, we recognized 780 million—sorry, thousand in revenue related to recognition of government grants.
Our employee benefit expenses amounted to 8.5 million, which is in line with Q4 and about a million below Q1 2025. We are expecting and we will be seeing lower levels of employee benefit expenses going forward, partly in Q2, but the larger effects we will see in Q3 and onwards.
We are expecting these reductions to amount to around 35% of the current cost base. Other operating expenses amounted to 9.5 million in the quarter, which is down significantly both from Q4 and from Q1 2025, where they were at 12 and close to 14 million.
We had in total operating expenses of 32.3 million, adjusted for the impairment loss that would be 20 million, and the same numbers for Q4 were 23 million and 25 million. We are lowering our cost base.
If we then move to the next slide on cash flow, we started the quarter at 6 million in cash. Through the capital raise done through the rights issue and the following exercise of the first tranche of the warrants, both in Q1, in January and March, we raised in total 101 million in net proceeds.
However, at the same time, we also repaid bridge and shareholder loans of 52 million, and these, as were secured in 2025 in order to bridge the company's operating expenses leading up to the completion of the rights issue in January. Further, we had R&D expenses amounting to 5 million and other operating expenses including salaries of 12.
We further had a timing effect related to accounts payable, and we used approximately 10 million to repay supply credits in the quarter. This leads to the ending balance of cash at the quarter end of 26 million.
As mentioned previously, we have had a couple of capital raises through Q1. There was strong support from our shareholders, both in the January rights issue and the following warrant exercise.
The warrant exercise of the first series of warrants had a exercise ratio of 83% and raised 35.8 million in gross proceeds. We have current financing that secures us through 20—Q3 2026.
This does not take into account the next series of warrants that will be exercisable in the period between 1st and 12th of June. What I think is important to emphasize here is that the exercise of these warrants are done at a discount versus the share price, it's a good opportunity to contribute to the company both in terms of funding, but also at favorable prices.
In terms of capital use and financing, these are in line with what has previously been communicated, and we do not see any changes to our expectations for the next two years. We are going from a R&D-driven organization to a more product-development-focused, manufacturing, and of course into clinical trials.
This will of course be interesting and to follow, and also this is where the spending will go in the period that is ahead of us. With that, I will leave it to Joacim to continue with the outlook and summary portion.
Thank you.
Joacim Holter
Thank you very much, Petter. With that financial review, I would like to conclude by briefly summarize where we stand following the first quarter and how we currently view the next phase of our development.
Looking ahead, our immediate immediate our immediate priorities are increasingly execution-focused. The main near-term focus areas are to advance on the regulatory process, to prepare for clinical studies, continue optimization of course of implant stability and system robustness, and further strengthen the operational platform for scale-up and future commercialization.
At the same time, we continue progressing the CE mark documentation for the complete CGM system and prepare towards a limited veterinary market launch. As discussed earlier, we are still reassessing elements of the broader regulatory and operational pathway, including the transition toward Bergen-based manufacturing and operational integration.
We therefore expect to provide a more updated and specific roadmap as this work progresses further. To summarize, Q1 represented an important transitional quarter for Lifecare.
We have achieved reproducible in vivo system-level validation of the platform. We have confirmed continued implant stability under real-life conditions.
We have simplified the regulatory pathway toward a single pivotal CE mark study. We have initiated the operation operational transition toward a more scalable and integrated manufacturing model.
Taking taken together, these developments strengthen the foundation and future clinical progression, scalable production, and the eventual market entry. At the same time, we remain disciplined and realistic regarding the remaining work ahead, particularly within regulatory execution, quality systems, and production readiness and financing.
Overall, I believe that it's very fair to state that we believe that the platform and organization are materially stronger exiting the first quarter than entering it. With this, I thank you very much for your attention this morning.
The full report and presentation are available for download on our website, and we will now be happy to take any questions. What I would like to do now is to go to the Q&A.
I just need to find the section, apologies for that. There is the Q&A section where I know that is already uploaded some questions, and please feel free to to increase the number of questions at all times.
The first question is related to the pet market and partnering, and I'm going to read it out: "Could you elaborate on the commercial strategy for the pet market, and are you already in discussions with potential sales or distribution partners in Europe?" I'm not in a position to to give a comprehensive update on the neither the commercial strategy or or kind of our positioning within towards the the veterinary market.
I think it's important to once again emphasize the fact that our pets veterinary market strategy is first and foremost designed to support the the clinical development, the human development. However, we are in dialogue with several potential partners on the veterinary side.
Whether we decide to go alone to market first to do the first initial launch or if we are positioned to get into a partnering deal at an early stage still remains to be seen and is pending of course the the interactions that we have with potential partners. The next question is related to financing and strategic capital, and it's it it's it is that "You mentioned strategic capital as one possible financing source.
Could this include an industrial or commercial partner, and is this something you are actively exploring on?" I would say that the question to the answer to the first part of the question is yes, we of course strategic capital could include an industrial or commercial partner.
It could also include other elements. However, we are this is part of of course the strategy going forward, especially towards the pet market, but but would also increasingly be part of the strategy going forward towards the human market.
When it comes to the resubmission, the next question is related to resubmission and regulatory timeline: "After the work with LINK Medical and the updated regulatory strategy, when do you expect to clarify the timeline for the pivotal CE mark study and resubmission process?" There are two elements that that is directly impacting when we can provide an update on the timelines here.
The first is that we are currently in the middle of an ongoing kind of formalized reassessment of our regulatory strategy going forward. We're working with LINK Medical on that field, and we expect to to receive the first draft and also to be able to conclude on on that on the reassessment within weeks, hopefully by end of May, but but at least within mid-June.
The second thing that impacts the the timeline going forward is when we are actually able to do the production ourselves. Up to date, we have done it on our own production line, but externally at a consultant in the UK.
As we have explained, we are now moving this to Bergen. We expect to be able to do that to to be up and running with that production within this summer.
We, as part of the regulatory strategy assessment, we will also of course take this into consideration and be able to provide a better and more specific timeline on on the path forward. We hope to do that as quick as possible, but we plan to do that no later than the next quarterly report in August.
The next question is: "When should we expect the start of launch activities in the vet market? Is this too optimistic to anticipate revenue already in—is it too optimistic to anticipate revenue effect already in H2 2026?
What is the go-to-market strategy? You have previously mentioned going to selected veterinary clinic clinicians.
How does this like look like now?" It is too optimistic to expect any revenue from the vet market in the second half of 2026.
We have a an alternative road towards the veteran market, which would include limited sales through through dedicated veterinary clinic clinics. That is, however, depending on our production capacities.
We still look forward to be able to say we are now going to the veterinary market. However, this is, from a strategic perspective, first and foremost supporting the human process going forward, hence we are not now in a position where we can be more specific on that timeline either, other than to state, as we have said previously, it is not to be expected a a significant revenues from that on the short term.
The next question is numerous questions, first one being: "When you write in report successful validation in vivo, does that include numerical glucose accuracy? How should we interpret that statement?"
I think, first of all, this is an ongoing study. Hence, I think that it's it's not fair to to kind of create snips of that that is conclusive and maybe optimistic before we have the full picture of the study and can make firm conclusions.
Until that, we are going to remain on the statement that we are seeing glucose-relevant variations from the raw in vitro data, which is from our perspective a significant achievement. The reason for that is that as as soon as we have a volume of data that is glucose and physiologically glucose-relevant, it increases our progress towards actually being able to translate these numbers into numerical values.
We need to both spend the time wise and spend the data wise so that we hit the spot on before we go ahead and confirm that publicly. The next question is: "When will you provide more data and/or results of the longevity study?"
We have not been sharing any specific data from one and one dog, and we will also not do that. What we will do is that we will continue to inform about, the significant milestones in terms of durability in real life, under real-life conditions, etc.
However, I I ask you to, unfortunately, I have to ask you to be a bit patient when it comes to the actual study outcome because this is part of the overall study. We need to work on that, and we will come back with the analysis when we close down the study as is.
Next question is that the single CE clinical investigation: "Any details on the detailed assessment, and what would the approximate study design look like?" To that, what I can say is that the study design We already have outlined a study design for the CE study that has been on our table and on the board's table for close to a year.
This has been pending and waiting for the first-in-human study. We have the sketch, we have the framework for the the clinical study.
However, as we now are in the middle of doing a overall assessment of our forward regulatory strategy, this also of course includes the clinical strategy. We would be happy to share that when we have a final framework that we are ready to to share with the notified body.
That leads me over to the next question, which is: "How much additional capital would be needed for that CE trial? You state that the warrants will provide runway through to start of trial, but not other details if I'm not mistaken.
Can you tell us more on the financial outlook?" Our assessment and and direction in terms of the regulatory strategy is a cost-reducing has a cost-reducing effect.
What we're doing effectively is that we are taking out the first-in-human study based on the feedback and the advice that we have received from LINK Medical and the prospective notified body. This leads to a cost reduction.
We do not see that the our plans for the CE study, previous or current, will lead to any increase of of capital expenditure. What I think is also important to note here is the fact that while the board at the Q4 report and also to quite some extent at the annual report for 2025 expressed some concern concerns related to the going concern statement, the quarterly report for Q1 significantly reduces the wording from the board, where the uncertainty related to the ongoing going concern is taken out.
The reason for this is twofold. As you will see on our capital base, we are have a strong increase, we have a improvement compared to the first to the last quarter of 2025 going out of the first quarter of 2026.
The other part of this is the fact that we have done significant cost-reducing measures throughout 2026 2026 to date, both related to the regulatory strategy and also related to the operational strategy. It is stated in the report that we envision from we envision soon a reduction of salary levels corresponding to 30% to 35% based on on the winding down of Germany.
In addition, as part of this winding down, we also have lease agreements that we are are in process of exiting from, hence the overall cost reductions from this operational restructuring is significant. Obviously, to set up production in Bergen will impair some costs.
However, the costs of this setup is significantly lower of what we would have to use anyway setting up this production in Germany. All in all, I think that the financial outlook for the company, even though we have funds that can appear limited, I would say that the financial outlook has materially improved since the last quarter, and we are looking forward to execute on our plans based on a cost model that is aligned with our available capital.
Then last question as far as I can see to now is: "Given the manufacturing transfer to Bergen, does the established reproducible manufacturing process need to be revalidated after transfer? How much would that cost, and how long time can that take?"
I briefly already touched upon that, but let's go a bit back and just establish the the basic facts here. Our production or manufacturing processes are set up at a consultant in the UK.
The plan for Lifecare was to move that to our production capacities in Germany. However, from a strategic after a strategic reassessment, we decided to not do that.
We decided to rather bring it to Bergen. Taking into account the cost reductions we are seeing due to the wind-down of the German company, and the cost and the increased costs in Bergen, we can say that the path we are following now is more cost-efficient.
There will not be additional costs compared to what we have signaled earlier. When can we expect the question is how long time can it take?
We expect to be operational to produce in Bergen in at least in the third quarter of 2026, which would be the same time as we would be operational in Germany. Hence, there is no changes there.
We are sending, what can I say, we are sending a delegation to to the UK within the next week to start the process of taking over. This will also include to actually do production of a new batch of implants.
All in all, I think that the strategic review we have done is definitely moving us forward towards a more efficient both operational and financial way going forward. Next question is related to the pet market: "Can the numbers sent from the implant be read on a smartphone, or is it currently displayed on another device?"
Short answer: it can be read on a smartphone. Then there is a question: "With the VWAP period for Warrants 2 starting soon, can investors expect any operational or regulatory updates in the next two weeks?"
It's a tricky it's a tricky question. Obviously, we are aware of the fact that we have a VWAP period coming up.
However, we are not positioned to to to influence on the operational or regulatory updates related to when the VWAP period actually occurs. This is pending the feedback and the work we are doing with LINK Medical at the time, and of course also on the progress we are doing on on moving the on moving the the operations to Bergen.
What I can say from a general perspective is of course that we will provide updates as soon as we are ready to do so, when we have the full picture, the full information, and and are able to to to provide solid updates. What I can share with you is and I'm obviously going to be a bit careful on on sharing our plans for communication going forward.
However, we are progressing on the strategic reviews, and we hope to be able to disclose a more comprehensive overview on that field within not too long, but but unfortunately we have to ensure that this is done in in due time and and the right right order. We will come back with that as soon as we can, and we will then of course update the market as a whole accordingly.
To my understanding, we have no more questions. That indicates that we are done with this quarterly report.
Once again, I want to thank you for participating this morning. Thank you for your questions, and thank you for your interest in Lifecare.
Looking forward to see you at the next quarterly report with a more comprehensive update on our forward pathway. Thank you for your attention, and I wish you all a There was a new question.
Sorry about that. Let's just take that before we close it: "Is the app for smartphones developed by a third party?"
Answer is yes, it is developed by a third party. With that, I thank you for your attention, wish you all a great weekend when it comes, and of course a great National Day for all Norwegians participating.
Have a good day. Thank you.
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