Nykode Therapeutics AS (NYKD) Q4 FY2025 Earnings Call Transcript & Summary

Greetings, and welcome to the Nykode Therapeutics Q4 2025 Financial Results Presentation. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to introduce Chief Executive Officer, Michael Engsig. Please go ahead, sir.

Thank you very much, Kevin, and a very warm welcome to all participants at this quarterly presentation from Nykode, 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 statements. We assume you are all familiar with these statements. On that notice, we'll move forward. Happy to again have with me here today in the room, Agnete Fredriksen, our Co-Founder and Chief Scientific Officer and Head of 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 Gurvin, 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 3 different assets through which we intend to build value in the near to long term for Nykode. Our lead asset is abi-suva, our HPV16 therapeutic immune therapy, which we are in the startup phase of a randomized clinical trial called Abili-T in first-line recurrent metastatic head and neck, and are on track to deliver meaningful interim results in 2027. Our second asset is VB10.NEO, 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. Company remains well capitalized with a cash runway that takes us into '28, which is past the first significant inflection points, including the interim data from the Abili-T trial. It's been another eventful quarter, the fourth quarter, also looking into the beginning of first quarter of this year, of course, mainly dominated by the progress on abi-suva in preparing for the start of Abili-T trial. So we already made a report that we submitted to the U.K. authorities back in November, then we also -- sorry, submitted the trial applications to the European regulatory authorities in December. Somewhat positively surprised. We already gotten approval from the U.K. authorities in December, which marks a record time for us to get approval for a trial applications in U.K. So we're very happy with that progress. And in addition, as you have noticed yesterday, we announced the interim data from the C-03 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 ICHNO conference on the 20th of March. VB10.NEO, progress have mainly been on our NeoSELECT algorithm, our machine learning-driven algorithm that helps us pick out the right epitopes for building into the individualized therapies. And here, we both presented data that shows and documents our NeoSELECT ability to pick the right antigens, and we also reported the grant of a U.S. patent for our specific NeoSELECT algorithm. And we'll have on media detail a little bit more about that. On tolerance, we did continue and we will continue to generate data that puts the -- our ASIT platform really into the forefront of this field, very exciting field, which represents a new way of addressing not only autoimmune diseases but potentially also allergies and organ transportation rejections, et cetera. And here, we're very happy with the progress we also have shown in fourth quarter and continue to see a beginning of first quarter. A few more words on abi-suva. So we have announced that our focus right now is, first and foremost, on first-line recurrent metastatic head and neck, which represents a commercially attractive patient population with more than 60,000 incidents per year in U.S. and EU. It's a patient population that today is not well served by available medicines and the standard of care still leaves 4 out of 5 patients without tangible benefits. The overall survival of patients in this area is 12 months. So a patient population with a significant remaining unmet medical need. Most of the products that are in development for the head and neck space are focusing or will be focusing on the HPV-negative population, which is distinctly different from the patient population we address, which is the HPV-positive patient population and these 2 different cancer are really 2 different cancer types. We still see expectations for a growing market 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 a significant expected compounded growth over the next decade of close to 10%. So this is our current focus. We still see a significant upside for abi-suva by looking at the total patient population driven by HPV16 infections. Of course, first and foremost, looking at the cervical cancer field, where we have already generated a very compelling data with the C-02 trial. This represents a significant commercial upside opportunity for abi-suva to be addressed in the future. So with the data we presented yesterday from our C-03 trial, this represents the second time where we combine abi-suva with a checkpoint inhibitor and see results that are significantly higher than what would be expected with a checkpoint inhibitor monotherapy, which represents standard of care in both these occasions with the C-02 trial where we investigated our abi-suva in combination with atezolizumab in second line and beyond recurrent metastatic cervical cancer, we saw an injective response rate of 29% and the standard of care, so atezolizumab alone have given a result of 16%. That represents an increase or 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 3.5% for our combination, abi-suva with pembrolizumab, 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 Abili-T, which will investigate abi-suva in combination with pembrolizumab, which is standard of care for these patients, randomized compared to pembrolizumab alone, as I said, standard of care. We're randomizing patients 1:1, so approximately 50 patients in each group. And our primary endpoints of this trial, there are 2 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 1/3 of the patients has been enrolled in 2027. So just to recap on abi-suva, 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 the U.K., and we look forward to engage with the European authorities and 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 first half of 2026 with our current plans that obviously would be expected to be in U.K. since we 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. With those words, I'm going to hand over to Agnete to take us a little deeper into VB10.NEO.

Thank you, Michael. As Michael mentioned, our strategy for VB10.NEO is to position ourselves as the most attractive unencumbered INT 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 tight interactions 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 neoantigen therapies in the future for pharma companies and ourselves. That includes clinical experience. So importantly, Nykode do have promising data from 2 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 patients and select the ones that should be included into the vaccine design. And here, we have a proprietary NeoSELECT algorithm that can select the relevant neoantigens. 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 time as well as a competitive cost 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 were happy to see another granted patent that further build on the previously granted U.S. patents for the vaccine concept of individualized neoantigens for Nykode. Now we also got a grant for the proprietary NeoSELECT algorithm that selects the antigens where we incorporate into that 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 2 clinical trials at the Society of Immunotherapy Congress, where we could further go into details of the effect of the NeoSELECT's ability to prioritize immunogenic neoantigens 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 the first Phase III randomized clinical trial in adjuvant setting of melanoma potentially coming out this year, event driven. And also a Phase II randomized trial in renal cancer plus a couple of Phase I trials. And then we also expect to see further readouts from additional Phase III trials in the beginning of '27. And that comes on top of BioNTech's Phase II trial, 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 neoantigen therapy. If you go to the next. Short update on our tolerance program as well from this period. Again, in tight dialogue 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 efficacies 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 patients too frequently, but rather induce a long durable response, which we've also seen in preclinical data. And the third, which we have some update on here in the Q4 report is the immune regulation. So we really want to see induction of these regulatory tolerizing T cells. But in addition, importantly, we really want to see a subsequent effect on the auto-antibodies as well as other disease causing T cells, including the CD8 or killer T cells. And then on the more [ PBMC ] 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 manufacture and deliveries that is already proven in the clinic. So we are in good position here. And if you move to the next. In Q4, we were very enthusiastic about these 2 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 aiming to show an 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. And then in addition, we have moved into an additional preclinical disease model, vitiligo, where the pathogenesis is caused by the CD8 killer T cells. And 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. If you 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 the vaccine's relevant for the clinical setting with the human version of these APC-targeting units that binds to humans cells. It's a human system that we show here and 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 where we have induced the state of inflammation in these human cells and the cells are already producing the cytokines, TNF alpha, IL-6 that we don't want to see in a tolerizing setting. We see that by treating the cells with our construct, one version that's 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 are fully supportive of our technology and what we can do with our technology by changing the APC-targeting unit. So if you move to the next, 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 a 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 '24. The reduction is driven by the cancellation of the agreement with Genentech in the fourth quarter of 2024 and also reduced income under our agreement with Regeneron. Total operating expenses reduced from USD 12.9 million in the fourth quarter of 2024 to USD 8.1 million in the fourth quarter of 2025, reflecting the reduced organization following the organizational streamlining finalized in the first quarter of 2025 and also reduced clinical activities. It should be mentioned that 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 reflects -- relates to interest income and unrealized currency movements on Norwegian kroner exposure. So 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 noncurrent receivable amounting to $32.2 million at the end of the fourth quarter as further described in the quarterly report. Nykode 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. A positive outcome will 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, Harald and Agnete. Just to finish off with a quick look at the outlook. We are -- have been looking at a very busy 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 Abili-T trial. And we will be, as I said, detailing data from the interim data from the C-03 at the ICHNO conference plus additional conferences in the second quarter of 2026. We are looking forward to see the approval of the Abili-T trial in the EU countries and the first patient dosed within the first half of '26. We are expecting to see readouts from our key peers in this space of individualized neoantigen therapies, which is, of course, will be very determining for how these fields move forward. And we, of course, also expect to see continued progress on our ASIT platform along the way of what Agnete detailed 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 Abili-T trial in 2027. And we'll also here expect to see further important key peer readouts from the INT field, in particular, from the larger pivotal 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.

[Operator Instructions] First question today is coming from Georg Bjerke from ABG.

What do you consider the key differentiating factors for abi-suva versus competitors? And how substantial do you consider those advantages over time?

Thank you very much, Georg. I think we'll ask Agnete to put some words on that.

I can certainly. So there are different buckets 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 2 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 we -- you normally see an upregulation of an EGFR receptor. And that's where the main competitors that are called Bicara, et cetera are focusing with EGFR-specific treatments. And those are, in principle, not particularly overlapping with the HPV-positive patient population that we are targeting. So important to bear in mind. When it comes to the HPV-positive head and neck cancer patients, the primary interesting developments in the space is actually HPV-specific vaccines. And 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 HPV16-specific vaccine. Importantly, they have so far reported data from 15 patients. We reported data from 13 patients as of this week, very similar objective response rates, they have 2 different versions of -- and presenting those data, investigator-driven or others. So 33% and 40% objective response rate, which means in the same range as 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 rejection injections over a course of 2 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 based in U.S. that is also running trials there, currently on pause, potentially reinitiating a trial at the moment. So we follow that company as well. But in our space, it means very limited competition interestingly.

We do have a follow-up from Georg.

How should we think about the development of operating expenses in 2026 versus 2027?

Do you want to take that, Harald?

Yes, sure. I mean if you look at the cash position we had 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 than '27. If you look at employee benefit expenses, we expect those to be stable based on the organization we have today. And there, of course, as I mentioned, there are some accruals in the fourth quarter, year-end accruals. So I would look more to the third quarter employee benefit expenses for a more long-term picture. And then as the Abili-T 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 C-03 trial, which has a limited number of patients.

Our next question today is coming from Geir Holom from DNB 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. Geir, thanks. So obviously, we have now reported our main strategy is to initiate and conduct the Abili-T randomized clinical trial that provides definitive data we need to show how abi-suva works in the large and 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.

[Operator Instructions] Our next question is coming from Luis Santos from H.C. Wainright.

For a moment in Abili-T, what assay will be used for HPV16 DNA. Will it be immunohistochemistry or circulating DNA? And how will this impact enrollment, please?

Yes. Thank you, Luis. 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.

We do have a follow-up from Luis Santos from H.C. Wainright.

In your view, what would be a win in terms of durability of response in the next HNSCC readout?

Thank you very much, Luis. Also good questions. And just here, that's an opportunity to remind people that what we saw in the C-02 trial. So in second-line and beyond recurring metastatic cervical cancer was actually the ORR we observed in our trial compared to what have 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 Abili-T 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 C-02 trial. So basically a doubling of the PFS and the median overall survival parameters compared to standard of care. And the last question?

We do have a question coming from [ Bjorn Alesion from BoA] .

How do you see the possibility to land partners that will bring revenues in 2026?

Yes. 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 abi-suva, 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 of 2026.

We 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 I said, we look forward to a further update on the data from the C-03 interim data set at the ICHNO conference a month from now as well as updating on new data from our ASIT tolerance platform already next week. So stay tuned, and have a good day.

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