Nykode Therapeutics As

Greetings and welcome to the NICO Therapeutics Q4 2025 financial results presentation. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation and you may ask a question at any time by typing it into the ask a question feature on your screen. As a reminder, this conference is being recorded. It's now my pleasure to introduce Chief Executive Officer Michael Ensign. Please go ahead, sir.

Thank you very much, Kevin, and a very warm welcome to all participants at this quarterly presentation from NICODE, where we look forward to take you through the fourth quarter and achievements happening subsequent to the quarter. Just a quick reminder before we start of the forward-looking statement. We assume you are all familiar with these statements and that notice will move forward. Happy to, again, have with me here today in the room Aonita Frederiksen, our co-founder and chief scientific officer in health and business development. who will take us through a deeper dive on our status for the NEO program and our tolerance program, as well as Harald Guggen, our CFO, who will take you through the financial data towards the end of the presentation. Again, as a sort of recap, reminding everybody of our strategy, which we announced in August last year, a very clear and focused strategy on three different assets. through which we intend to build value in the near to long term for my code. Our lead asset is Abisuva, our HPV16 therapeutic immune therapy. which we are in the start-up phase of a randomized clinical trial called Ability in first-line recurrent metastatic NEC, and are on track to deliver meaningful interim results in 2027. Our second asset is VB2Neo, our individualized neoantigen therapy, where we are positioning ourselves to leverage anticipated key peer readouts in the individualized neoantigen therapy space which we expect, based on guidance, will come like pearls on a string over the next 15 months. Our third asset is tolerance, our Antigen-specific immune tolerance platform, which we continue to progress forward, aiming to position ourselves as best-in-class in this field here. The company remains well-capitalized. with a cash runway that takes us into 28, which is past the first significant inflection point, including the interim data from the Ability trial. It's been another eventful quarter, the fourth quarter, also looking into the beginning of first quarter this year. Of course, mainly dominated by the progress on Bisuva in preparing for the start of Ability trial. So we already made a report that we submitted to the UK authorities back in November. Then we also submitted the trial applications to the European regulatory authorities in December. Somewhat positively surprised, we already got an approval from the UK authorities in December, which marks a record time for us to get approval for a trial application in the UK. So we're very happy with that progress. And in addition, as you will have noticed yesterday, we announced the interim data from the CO3 trial. showing an objective response rate of 38.5% in first-line head and neck cancer, which is significantly higher than what would be expected with the current standard of care, which is 19% objective response rate. And we look forward to further detailing these results at the IGNA conference on the 20th of March. With B10neo, the progress has mainly been on our NeoSelect algorithm, our machine learning-driven algorithm that helps us pick out the right epitopes for the building into the individualized therapies, and here we both presented data that shows or documents our NeoSelect ability to pick the right ingredients, and we also reported the grant of a U.S. patent for our specific NeoSelect algorithm, and we'll have on the detail a little bit more about that. On tolerance, we continue, we did continue and we will continue to generate data that puts the OurACID platform really into the forefront of this field, a very exciting field, which represents a new way of addressing not only autoimmune diseases, but potentially also allergies and organ transplantation rejections, etc. And here we're very happy with the progress we also have shown in the fourth quarter and continue to see in the beginning of the first quarter. A few more words on Abisuva. So we have announced that our focus right now is first and foremost on first line recurring metastatic head and neck, which represents a commercially attractive patient population with more than 60,000 incidents per year in US and EU. It's a patient population that today is not well served by available medicines and the standard of care. still leaves four out of five patients without technical benefits. The overall survival of patients in this area is 12 months. So a patient population with a significant remaining unmet medical needs Most of the products that are in development for the head and neck space are focusing or will be focusing on the HPV-negative populations, which is distinctly different from the patient population we address, which is the HPV-positive patient population. And these are really two different cancer types. We still see expectations for a growing mark in this field over the next decade, despite the emergence of prophylactic vaccines, probably most likely because of a limited penetration in key areas and changed behavior in patients. So we do see significant expected compounding growth over the next decades of close to 10%. So this is our current focus. We still see a significant upside for Abisuva by looking at the total patient population driven by HPV16 infections. Of course, first and foremost, looking at the cervical cancer fields where we have already generated very compelling data with the CO2 trial, this represents a significant commercial upside opportunity for Abisuga to be addressed in the future. So with the data we presented yesterday from our CO3 trial, this represents the second time where we combine Abizuva with a checkpoint inhibitor and see results that are significantly higher than what would be expected with a checkpoint inhibitor more therapy, which represents standard of care in both these occasions. With the CO2 trial, where we investigated Abizuva in combination with a T-Cellizumab in second line and beyond recurring metastatic cervical cancer, we saw an objective response rate of 29%, and the standard of care, so atisolizumab alone, have, again, results of 16%. That represents an increase or an 80% higher response rate than what you would expect with checkpoint inhibitor monotherapy. Even more impressive, what we saw yesterday, was an objective response rate of 38.5% for our combination, Bisuva with pimpolizumab, which should be compared to what Pembrolizumab gives as monotherapy in this patient population, 19%, so more than a doubling of the objective response rate. We look very much forward to further elaborating on those clinical data at the ICHNO conference and beyond. And the ICHNO conference takes place on the 20th of March. This gives us the necessary confidence to progress into the randomized clinical trial called Ability, which will investigate Apisuba in combination with Pembrolizumab, which is standard of care for these patients, randomized and compared to Pembrolizumab alone, as I said, standard of care. We're randomizing patients one-to-one, so approximately 50 patients in each group. And our primary endpoints of this trial, there are two primary endpoints. We'll be looking at both objective response rate as well as progression-free survival. We have already announced that we are planning a series of interim results, the first one coming out after one-third of the patients has been enrolled in 2027. Just to recap on Avisuva, this quarter or fourth quarter did see good progress on our preparation of preparatory activities. We are slightly ahead of where we plan to be with the fast approval from UK and we look forward to engage with the European authorities also expect to see or hope to see an approval within Europe in first half of 2026. That obviously brings us into an expected first dose in the first half of 2026 with our current plans that obviously would be expected to be in the UK since they are a little bit ahead of the curve here. Now, based on that guidance, we are still well within range to see meaningful interim readout in 2027, which is, as I mentioned before, within our cash runway. Those words I'm going to hand over to Almeida to take us deeper into VB10neo.

Thank you, Michael. As Michael mentioned, our strategy for VB10neo is to position ourselves as the most attractive unencumbered R&T in the period that we are awaiting the data readouts from our peers, primarily those companies that have successful COVID vaccine sales, which are currently investing heavily in individualized neoantigen therapy randomized trials, which we expect to see readouts from within the next 15 months, as Michael mentioned. In that period, we are keeping a tight interaction with potential future partners for this program. And in that dialogue, we substantiate the key factors that will be important for interest in pursuing further individualized new antigen therapies in the future for pharma companies and ourselves. That includes clinical experience. So, importantly, MICA do have promising data from two clinical trials across multiple indications that show clear vaccine-induced immune responses. Another important factor for this field specifically is that you need to have a tool that can select the appropriate neoantigens per patient, which means the mutations that are cancer-specific for each individual patient, and select the ones that should be included into the vaccine design. And here we have a proprietary neo-select algorithm that can select the relevant neo-antigens. And then third, but not least, third and fourth, which are connected, important to have an established supply chain where you can prove that you're able to have a robust and competitive turnaround plan, as well as a competitive cost our goods and manufacturing complexity here is obviously directly linked to the cost since we manufacture one vaccine per patient. So if you move to next Michael. In Q4 we had some important milestones for this program while being cost effective. We are happy to see another granted patent that further builds on the previously granted US patent for the vaccine concept of individualized neoantigens for NIFO. Now we also got a grant for the proprietary neo-select algorithm that selects the antigens that we incorporate into the vaccine. Important for us to get this substantiated and fully granted. And then in the same period we We're happy to present some new data, new analysis from the two clinical trials at the Society of Immunotherapy Congress, where we could further go into details of the effects of the neo-select ability to prioritize immunogenic new antigens with both clinical and immunological relevance. We go to the next. So, as Michael mentioned, within the next 15 months, we're in a very interesting period for these individualized neoantigen therapies. We see Moderna just recently updated their guidance with a potential readout of both their first phase three randomized clinical trials in an adjuvant setting of melanoma, potentially coming up this year, event-driven, and also phase two randomized trials in renal cancer plus a couple of phase one trials. And then we also expect to see further readouts from additional phase three trials in the beginning of 27. And that comes on top of BioNTech's phase two trials primarily in the colorectal space that is also expected. this year. So it's actually in the next few months that we will see a lot of interesting readouts that will determine the future of individualized knee antigen therapies. We can go to the next short update on our tolerance program as well from this period. Again, in tight dialogue with with key opinion leaders and potential partners. The key factors for developing this successful antigen-specific immunotherapy platform is to show that we are able to induce therapeutic efficacy across disease models, bearing in mind that we are at the preclinical stage here and it's a very novel treatment modality that we are developing. And we have seen therapeutic efficacy across disease models recently. We've also been able to show durability, so important in this disease, you don't want to have to treat the patient too frequently, but rather induce a long, durable response, which we've also seen in preclinical data. And the third, which we have some updates on here in the Q4, report is the immune regulation. So we really want to see induction of these regulatory-tolerating T cells. But in addition, importantly, we really want to see a subsequent effect on the autoantibodies as well as other disease-causing T cells, including the CD8 or killer T cells. And then on the more CMC side here, in order to include the multi-antigens into the vaccine is important in this field as different diseases autoimmune diseases include multiple different antigens that can be of relevance for different patients and the ability to have a vaccine platform that can incorporate multiple antigens will be a huge benefit in the future and then we build on that manufacturing delivery that is already proven in the clinic. So we're in a good position here. And if you move to the next. In Q4, we were very enthusiastic about these two data in particular that was presented on different conferences. One is that we actually are, as far as we know, the only company that has been able to show and ability to reduce the number of the level of auto antibodies after starting to treat after the onset of disease in this preclinical model and then we know multiple autoimmune diseases are directly linked to these auto antibodies being pathogenic so for us this is a huge step forward In addition, we moved into an additional preclinical disease model with the LIGO, where the pathogenesis is caused by the CD8 killer T cells. We were able to also see a reduction on these particular relevant pathogenic T cells in this model, which we also have not seen any other antigen-specific immunotherapy technologies being able to show. So for us, these data are very important to publish and to talk to potential partners and key opinion leaders in the field in order to move this program forward. We go to the next, Michael. Further here in Q1, we show you that we are moving closer to the clinic and we have data that supports that we can also make these vaccines relevant for the clinical setting with the human version of these ICT targeting units that binds to human cells with the human system that we show here and that makes us more ready to move forward towards clinical trials in the future. and to the right here we see a very interesting factor that when we have these stimulated cells that where we have induced the state of inflammation in this human cells and the cells are already producing the cytokines tnf alpha and i6 that we don't want to see in a tolerating setting we see that by treating the cells with our constructs one version but where the APC targeting unit actually further increases this unwanted stimulation in this setting. And another version where we can see that it's decreasing this unwanted stimulation. And the only difference is our unique proprietary APC targeting unit. So these data fully support our technology and what we can do with our technology by changing the APC targeting unit. So if you move to the next slide. Michael, we are continuing to develop interesting data and getting closer and closer to finalize the work on the platform as such before we are ready to move further towards the clinic. And next week already, we are at the conference, which is the conference of the year that is fully focused on the antigen-specific immune tolerance space. And here we have a prominent role, both presenting in the conference, but also participating in the panel discussion and bringing a poster. And then in the same month, we are also presenting at the NextGen Biomed conference in London, where we will present new data. Then I think I'll hand over to you, Harald.

Thank you, Agnete. Looking at the key financials for the fourth quarter, we had no revenue compared to 6.8 million in the fourth quarter of 2024. The reduction is driven by the cancellation of the agreement with Genentech in the fourth quarter of 2024 and also reduced income under agreement with General. Total operating expenses reduced from 12.9 million in the fourth quarter of 2024 to US 8.1 million in the fourth quarter of 2025. Reflecting the reduced organization following the organizational streamlining finalized in the first quarter 2025 and also reduced clinical activities. It should be mentioned that the employee benefit expenses are slightly higher in the fourth quarter compared to the third quarter due to some year-end accruals. Finance income and costs were net $40,000 positive in the fourth quarter, which mainly relates to interest income and unrealized currency movements on Norwegian crown rate exposure. Overall, we recorded a net loss of $8 million for the fourth quarter, compared to a net loss of $6.8 million for the same period in 2024. Moving on to the balance sheet, we are still well capitalized with a cash position of $60.3 million at the end of the year. With disciplined execution and strong financial focus, we will reach key inflection points within the estimated cash runway into 2028. This does not include the pending tax case, where we have booked a non-current receivable amounting to 32.2 million at the end of the fourth quarter, as further described in the quarterly report. NICODE is confident that we will receive a positive ruling in the tax case, also based on advice from third-party experts. We have also received a letter from the tax authorities that we can expect an outcome of the appeal within the first half of 2026. A positive outcome would push the cash runway into 2029. Moving on to equity liabilities, we have total equity of 91.5 million, which represents a strong equity ratio of 92%. And with that, I will give the word back to Michael.

Thank you very much. And just to finish off with a quick look at the outlook, we have been looking at a very basic and very productive last quarter. We're looking into a very exciting upcoming period in front of us with a lot of progress on the ability trial. And we will be, as I said, detailing the interim data from the CO3 trial at the IGNO conference plus additional conferences in the second quarter of 2026. We are looking forward to see the approval of the ABILITY trial in the EU countries and the first patient dosed within the first half of 2026. We are expecting to see readouts from our key peers in the space of individualized neuroendocrine therapies, which of course will be very determining for how these fields move forward. And we of course also expect to see continued progress on our ACID platform along the way of what I will be detailing today. If we look even further into the future, over the next 12 to 24 months, we are on track to see the first interim data from the AbilityTrial in 2027. And we'll also here expect to see further important key peer readouts from the INT field, in particular from the larger pupil trials that have been initiated in both melanoma and lung cancer. So exciting times ahead of us. And with those words, this concludes our formal presentation. We are ready to take questions.

Thank you, and I'll be conducting a question and answer session. As a reminder, if you'd like to ask a question today, please type it into the Ask a Question feature on your screen. One moment, please, while we poll for questions. Our first question today is coming from Georg Berge from ABG. What do you consider the key differentiating factors for Abhisubha versus competitors, and how substantial do you consider those advantages over time?

Thank you very much, Geo. And I think we'll ask Onede to put some words on that.

I can certainly. So there are obviously different dockets of competitors. Let's focus on first just a sentence maybe on the difference between HPV positive and HPV negative head and neck cancer patients. So importantly, Those are two different diseases driven by different lifestyle factors, which means that they also have different targets that products are currently focusing on in their mechanism of action. And we've seen some interesting developments for the HPV-negative patient population, where you normally see an upregulation of an EGFR receptor, and that's where the main competitors that are called MERS and Bicara, etc., are focusing with EGFR-specific treatments. And those are in principle not particularly overlapping with the HIV-positive patient population that we are targeting. So important to bear in mind. When it comes to the HIV-positive head and neck cancer patients, the primary interesting developments in the space is actually HIV-specific vaccines. Although we've seen quite a few players in this field that is no longer active for multiple reasons, also based on negative data or financial reasons, no longer pursuing HPV positive cancer indications. We also now currently see BioNTech as the biggest player that is running trials with an HPV 16 specific vaccine. Importantly, they have, so far, reported data from 15 patients. We reported data from 13 patients. Also, this week, very similar objective response rates. They have two different versions of presenting those data, investigative-driven or others, so 33 and 40 percent objective response rates, which means in the same range. That's what we are seeing when you look a bit more detail into the data. There are some interesting factors there when it comes to patient compliance or durability of the responses that we will follow in detail. Also based on a pretty heavy vaccination regime with 40 IV injections, intravenous injections over a course of two years. So we believe we have some competitive edge when it comes to what we've seen so far from BioNTech there and following that space. Basically, there is one other company in the US that is also running trials there currently on pause, potentially reinitiating a trial at the moment. So we follow that company as well. In our space, it means very limited competition, interestingly.

Very good. Next question.

Thank you. We do have a follow-up from Georg. How should we think about the development of operating expenses in 2026 versus 2027?

You want to take that, Harv? Yeah, sure. I mean, if you look at the cash position, we had the year end 2025, that was $60 million. And then we have guided on runway into 2028. So that means we will spend around just below 30 million per annum in 26 and 27. If you look at employee benefit expenses, we expect those to be stable based on the organization we have today. As I mentioned, there are some accruals in the fourth quarter, year-end accruals. I would look more to the third quarter employee benefit expenses for a more long-term picture. Then as the ability trial picks up, that will of course increase the operating expenses as we have not been running any significant clinical trials in 2025 other than the CO3 trial, which has a limited number of patients.

Thank you. Our next question today is coming from Geir Holm from DMV Carnegie. To what extent are you actively working to initiate additional clinical trials, particularly along pathways that require less capital, such as investigator-led trials or potential partnerships?

It's a very good question, Gaia. Thanks. So obviously, we have now reported our main strategy is to initiate and conduct the abilities of a randomized clinical trial that provides definitive data we need to show how Albezuga works in the largest, most attractive patient population in this space here. So first-line recurrent metastatic head and neck Obviously, any initiatives to expand the addressable patient population would possibly create a good commercial business case with thoughts into the future for possible partnerships. So although this is not something we have taken any decisions on right now, we are constantly monitoring and discussing with potential parties what opportunities exist to do very capital-efficient clinical trials that wouldn't meaningfully move our cash runway, as I said, with the aim of expanding the addressable patient population. So we're not guiding on anything specific now, but this is something that we have on our radar guide.

Thank you. As a reminder, if you'd like to ask a question today, please type it into the Ask a Question feature on your screen. Our next question is coming from Luis Santos from H.C. Wainwright. For enrollment in ABLI-T, what assay will be used for HPV16 DNA? Will it be immunohistochemistry or circulating DNA? And how will this impact enrollment pace?

Yeah, thank you, Louise. So this is actually a question that we'll not answer specifically as this is an important part of our development and competitive intelligence that we want to keep close to our heart at the moment, but we do not see this impacting enrollment.

Can we do a follow-up from Louise Santos from HG Wienright? In your view, what would be a win in terms of durability of response in the next HNSCC readout?

Thank you very much. Those are also good questions. And just here, that's an opportunity to remind people that what we saw in the CO2 trial, so in signal and beyond recurrent metastatic cervical cancer, was actually the ORR. we observed in our trial compared to what has historically been shown with the standard of care was an increase of approximately 80%. That was on the objective response rate. However, when we moved to the durability parameters, we saw a more than doubling of the numbers compared to what is historically seen with standard of care, both on the progression-free survival as well as the median overall survival. So, of course, if we can see similar trends in the ability trial compared to standard of care, that would be a big win for the company. We think less is necessary for a regulatory path forward, but our aspirations are to see something similar to what we saw at the CO2 trial, so basically a doubling of the PFS and the medium-level survival parameters compared to standard of care.

And the last question.

We do have a question coming from Bjorn from Borea. How do you see the possibility to land partners that will bring revenues in 2026?

Yeah, thank you also for that question. So we now try to be very modest in guiding on partner activities. That's a painful lesson that is so difficult to predict in the world of biotech. So we're not guiding on any revenue from partners in 2026. And I would treat that as a heavy upside if it happens. I think we've been clear that when it comes to our Vesuvia, our expectations is that the main partner opportunities comes from the other side of the data generated from that trial. So we're not trying to create any expectations for significant partner revenues in the time before, in the time of 2026.

Thank you. We've reached the end of our question and answer session. I'd like to turn the floor back over to Michael for any further closing comments.

Thank you very much for the questions and for the participants dialing in. As we said, we look forward to further update on the data from the CO3 interim. datasets at the ICMA conference a month from now, as well as updating on new data from our ACID tolerance platform already next week. So stay tuned and have a good day.

Thank you. That does conclude today's teleconference webcast. We disconnect your line at this time and have a wonderful day. We thank you for your participation today.