Nykode Therapeutics ASA

Nykode Therapeutics ASA

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Q3 FY2025 · Earnings Call TranscriptNovember 24, 2025

Operator

Greetings, and welcome to the Nykode Therapeutics Q3 2025 financial results conference call and webcast. At this time, all participants are in a listen-only mode.

A question and answer session will follow the formal presentation. 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 turn the call over to CEO Michael Engsig.

Please go ahead, sir.

Michael Engsig

Thank you very much, Kevin. Also, from my side, a very warm welcome to all participants at today's Q3 report.

Just to remind everybody of our forward-looking statements, assuming you're familiar with the such statements, we will move ahead. As usual, it's my pleasure to have next to me here, Agnete Fredriksen, our Chief Scientific Officer and Head of Business Development, as well as Co-Founder; and Harald Gurvin, our Chief Financial Officer.

A quick recap on our company strategy, which we announced in Q3 this year, which really demonstrates our focus on our three core assets: Abisuva, formerly known as VB10.16, which is our lead asset and we're taking into a randomized control trial in Phase 2 in first-line head and neck; secondly, VB10.NEO, our individualized neoantigen therapy with potential to basically be a future therapy towards all cancer types, we're positioning this as the most attractive unencumbered INT asset ready to leverage peer data; and thirdly, our tolerance platform, which we are positioning as the best-in-class tolerance platform for treatment of autoimmune diseases, potentially allergy and other diseases in that category. We're also demonstrating a disciplined approach to capital allocation, strongly capitalized with a runway that lasts into 2028/29, we're going to add some more words to that later, which is on the other side of significant inflection points for the company.

It's been another busy quarter for us with progress on all our three programs. Obviously taking a lot of our efforts these months is the ABILITY trial, our randomized control trial for Abisuva, and we're very happy to announce that we have submitted the protocol to the UK authorities in November and we are expecting a submission to the EMA authorities imminently, which is, to be honest, a close to a record, if not a record time for us, to bring it from a decision on running a trial to actually submitting a protocol to the authorities.

We have also agreed together with our partners MSD on supply of pembrolizumab for this trial, which also means that MSD have been part of writing the protocol and approving it in its current design. Very happy and great thanks to the team for such a large effort keeping this trial on progress.

For our VB10.NEO program, where we have said earlier that we are focusing on also strengthening the proprietary position around our NeoSelect platform, the algorithm that selects the targets that we incorporate into our vaccines on a patient-by-patient basis, we've also seen good progress here. We have been granted a US patent for the NeoSelect platform, which is a very important part of protecting our exclusivity for this platform.

We have presented very exciting data across our two clinical trials that further demonstrates that NeoSelect is really picking out the best targets to be incorporated into a platform, and Agnete will tell you more about that later today. We have presented a series of novel data for our ACID platform, also called the tolerance platform, where we've shown the ability to see long and durable effect of our constructs even when delivered late in the development of the disease, which means it has really a therapeutic potential.

We've recently also shown that we have the ability to modulate also the so-called humoral compartment, which means the autoantibodies, and we are thus one of a very, very selected group of companies that can modulate all the compartments of the immune response. Agnete will also tell you more about that in a couple of slides.

Moving on to an update on Abisuva, and again, just to quickly remind everybody, Abisuva is our lead candidate. It's a therapeutic immunotherapy developed against HPV16-driven cancers.

We are moving this asset into a randomized controlled Phase 2 trial in first-line head and neck. We're doing this on the basis of having seen very encouraging data across three different clinical trials, of which two have been reported and one is ongoing, and two are in combination with immune checkpoints and one is a monotherapy.

We see consistent added benefit compared to what we would expect to see with checkpoint inhibitor monotherapy, both on ORR and overall survival. We see also consistently a strong correlation between the effect and the specific immunogenicity raised by this vaccine, which we really do consider a pivotal thing for a cancer vaccine to show credible data.

Next step for this is, as I said before, initiating the ABILITY trial, the randomized controlled trial, which will be enrolling up to 100 patients. We also expect to release the first interim data from the ongoing C-03 trial within the next 6 to 12 months, and we do also foresee that the ABILITY trial itself should be able to deliver the first meaningful interim data within the next 24 months.

This is not a trivial indication, and we do see, in particular within head and neck, the HPV16-driven number of patients are increasing over the coming years. Alone in the head and neck, we are looking at an incidence of more than 60,000 patients per year.

If you look at the current standard of treatment, four out of five patients don't really see any meaningful benefit for the current available treatments, which leaves significant room for improvements with future treatments. Most of the treatments that are in development in this space against head and neck are focused on the HPV-negative populations, which again makes the key opinion leaders seek more HPV-positive focused therapeutic options for the future.

If we look at the forecasted market or estimated market for this segment, the HPV16-driven segments, we are looking at significant growth with an annual compound growth rate of 9.2% between now and the next 10 years in front of us. ABILITY trial is going to be the first time we take Abisuva into a randomized controlled setting.

It's technically a Phase 2 trial with us expect to enroll up to 100 patients, split into two groups, randomized 1-to-1. One group will receive Abisuva plus pembrolizumab and the other one will receive pembrolizumab, which is standard of care.

The primary endpoint will be ORR and PFS. This is the protocol as we expect it to look right now.

As I said, we've just submitted this to the authorities in UK, expect to submit to the EMA authorities imminently in December, and then begin the interactions with authorities on the protocol and the study design. Also, as I said before, agreed the supply of pembrolizumab with MSD, and I here would like to thank the colleagues at MSD for their very gracious help on getting this trial designed and expeditely approved on the MSD side.

Without that, we would not be able to run this trial forward, grateful. Before handing over the word to Agnete, just want to remind you all here: ABILITY, our lead asset, moving into a randomized controlled trial setting for the first time, but we are expecting to deliver the interim data from C-03 in the first half of 2026 at a conference that we still have to identify and announce.

We feel we are very well positioned in the field of HPV16-driven cancers, in particular head and neck, and do see that we will be able to deliver the first meaningful interim readout of this trial within 24 months, which is within our cash runway. With those words, I'm going to hand over to Agnete to take us through VB10.NEO.

Agnete Fredriksen

Thank you, Michael. First, a little reminder of where we are at the moment with VB10.NEO.

We have performed two clinical trials with this fully individualized cancer neoantigen therapy. They have both been in heavily pretreated patients, which is different from where we see our peers currently moving, into very early-stage adjuvant setting.

In both of these trials in heavily pretreated patients, we have shown strong immune responses. We also in this particular setting when we make one vaccine per patient, the manufacturing process is extremely important.

The current setup we have at the moment has a competitive, robust 7-week turnaround time in the clinical setting, with potential for further improvements and cost advantage. This is an important factor for VB10.NEO compared to our peers in the field.

We do also have a need to select neoepitopes for each individual patient when we work with individualized cancer neoantigen therapies. We have developed a proprietary AI algorithm in order to select the optimal neoepitopes per patient.

We have shown that this prioritizes superior immunogenic neoantigens from the two clinical trials as well as preclinical data. In the future, we see now a very interesting defining period for individualized neoantigen therapies.

There are 10 ongoing randomized clinical trials from peers, Phase 2 and Phase 3 trials. This is really the highest investments in this field to date.

Many of these will read out within the next 15 months, which we know will be very important and, if positive, will further validate the concept of individualized neoantigen therapies, which will bring VB10.NEO in a very interesting position. In the meantime, our strategy is to further strengthen this position, building on the positive basis that we have at the moment, and focus on being the most attractive unencumbered INT through selected activities to leverage when these peer readouts come in the next few months.

These are some of the key success factors for an ideal INT candidate. We do believe it's important to already have clinical data, which we have; antigen selection, we do have a proprietary algorithm, and this is where I'll focus today with some progress that we've seen in this particular box for the last quarter; and then we're currently also working even more on the supply chain and the cost of goods in order to increase the competitiveness.

Here are data that we presented at the SITC Conference earlier this month, which we believe is very validating for the neoepitope selection method that we've developed here in-house. NeoSelect, when we select epitope per patient, we select up to 20 neoepitopes, so that's the number you see also up to 20 on the x-axis of the graphs here to the left.

We rank these epitopes, and the 20 best epitopes will make it in the vaccine design, and be able to be given to patients, and we can measure whether or not they were immunogenic. You can see here across both NO1 and NO2, you can see that there is a trend with the strongest immunogenicity and also for the high-quality antigens to be amongst the highest ranked neoepitopes.

You can see the ones we rank as number one also tend to be the optimal neoepitopes. That is extremely important in order to validate that NeoSelect is actually identifying the optimal neoantigens for the patients.

Importantly, Nykode has focused on not only incorporating features that are linked to immune responses against the neoantigens, but also technical and clinical parameters. That's what we incorporate in what we call high-quality neoepitopes in the ones that make it into the vaccine design.

We see that these immunogenic high-quality neoantigens are the ones that are mostly associated also with favorable clinical outcome, obviously, in patients with multiple different diseases, a heterogenic patient population, needs to be further validated in future trials, but very important signs going in the right direction here. Then, in order to solidify this, we have also very recently been granted another patent, another layer of protection for VB10.NEO, which actually then focuses on the neoepitope selection method that we have developed in-house.

It's now in US, and that is a patent that expires in 2039. Long protection here.

It's a US patent, we have already previously been granted patent for the method of selecting neoepitopes in Australia, China, Israel, and Japan, and Russia, which is going to be important for the future of VB10.NEO. Just to summarize, for this particular program, the peer readouts in the next 15 months is what we're all waiting for.

It can create a strong conviction for INTs. We do believe we are already in a good position, and we are continuing, as you also see here with the NeoSelect data and the patent protection, that we are continuing to strengthen our position in the field.

Then I think I'll move into the tolerance program. Just as a background here, when we say tolerance, we're working with truly antigen-specific immune tolerance.

This is a really new way of thinking about autoimmune disease treatment. The problem of today's treatments is that they focus on symptom management and do not really address the underlying root cause of the disease, which impacts also side effects and also the duration of effect to the current treatments that are offered for patients.

That impairs the quality of life of the patients. Unfortunately, autoimmune diseases affects a huge portion of our global population.

It's actually one in 10 that is affected by an autoimmune disease, which also means that there is a huge market for treatments addressing autoimmune diseases. With antigen-specific immune tolerance, truly antigen-specific, we have a vision to offer a prospect of a cure, which you cannot envision with the current treatments.

That's what we're aiming for with this program. When it comes to the key factors for a successful platform in this field, we both want to see therapeutic efficacy across diseases, and today I also show you additional new data from the last quarter, both within long durability in the EAE model as well as in a new model, vitiligo.

Then we need to see regulation of all major autoreactive disease-causing cells. Different autoimmune diseases, the reason for seeing disease can be caused by multiple different immune parameters, including autoantibodies, effector T cells, CD8, CD4, and we need to see a broad effect in order to envision that we can treat multiple different autoimmune diseases.

Another important factor here is to be able to incorporate multiple antigens. The different autoimmune diseases are caused by a range of different antigens, and the ability to have a vaccine modality that can incorporate multiple antigens will make it more likely that we can treat multiple different diseases.

Obviously, here also manufacturability and delivery, convenient delivery route is important here. Today, I'll show you new data basically in all of these boxes that are continuing to increase our conviction.

This data here were shown at a conference in August, where we started to treat mice that had already developed quite severe EAE, which is a mouse model for multiple sclerosis, that we're working on for multiple purposes. We started to treat the mice after they have developed clinical symptoms.

Still, we can see that we're able to provide a very strong therapeutic effect, but also importantly, very long-lasting therapeutic effect, even without continuing to dose the mice, only two doses here at an early time point. This is one of the things a antigen-specific therapy can offer compared to other treatments that only focus on symptoms.

Here is one of the data that we believe is very important and differentiating from what we've seen published from our peers. We have been able to reduce autoantibodies in mice models also when treating the mice in a therapeutic setting, which we have not seen from any of our peers as of to date.

This can be an very interesting competitive advantage of our technology, where you can see that the level of autoantibodies are decreased when we use our targeted vaccine compared also to a non-targeted vaccine. Then another sophisticated data here that we are pretty proud of is that we have been able to look into the central nervous system or spinal cord actually and look at the infiltrating cells, both here to the left then in the EAE model, where we see a reduction of and impact on the level of immune cells, a reduction of the disease-causing cells into the spinal cord, which is where we need these immune cells in order to change the course of the disease.

To the right, we've done an experiment looking into the pancreatic islets in the NOD model, that's a type 1 diabetes model, where we also see an increase of regulatory T cells in the affected organ as such. A lot of progress there on the disease models and also on the immune parameters.

When it comes to the multi-antigens, we also made a lot of progress the last quarter. We have incorporated all the competence that we have developed over the years also from our individualized cancer neoantigen epitope selection and our core competencies here in the team in-house.

We have now created constructs with multiple antigens from here a type 1 diabetes project, where we could identify multiple antigens, multiple opportunities to combine these antigens in one construct. Our model was able to take 2.7 billion possibilities down to 39 selected antigens, and we can see that a high percentage of this is actually very functional with long, complicated set of antigens is still being able to be produced with high quality and high yield.

This are now being tested in in vivo trials. This is also an important competitive factor, where we don't see all our peers being able to incorporate multiple antigens in one construct.

Then for translatability into the clinic, we know most competitors are focusing or are actually using intravenous delivery, which is complicated in the clinic. We have recently been able to compare when we inject our vaccines both intravenously and subcutaneously, which is a much more convenient method for the patients in a clinical setting.

We can see similar levels of efficacy when we give it subcutaneously, which will also be extremely important when we translate this into the clinic. Then as the last data slide here, we have, as I mentioned initially, now moved into a third disease model.

Initially here, looked at vitiligo, where we can induce the disease with a human TRP-2 antigens. This is a disease driven by CD8 T cells, and we have very promising data already from the first initial experiments here, where we can see the targeted vaccine is able to reduce the number of these disease-causing CD8 T cells.

Another example here of today showing you both an effect on CD8 T cells and autoantibodies, in addition to these more regulatory T cells that we see most of our peers are focusing on in their presentations. As to sum up, we feel more and more confident with the data we're generating and our path towards developing a best-in-class antigen-specific immune tolerance platform.

Seen a lot of progress from the last quarter here and a team working very hard and dedicated in order to get all this data. As a summary, we know that the current treatments are not optimal, they are focusing on symptom relief.

Our competitive strength, also amongst the other players in the field of antigen-specific immune tolerance, is both this long-lasting efficacy that we see now, but also the fact that we do observe an effect both on Tregs, CD8 T cells, and autoantibodies, and we also see this in affected organs like the CNS and the pancreatic islets. Interestingly, we see efficacy with recombinant protein delivered through convenient route of administration, sub-Q, as I've shown here today, which makes the hurdle less to move into the clinic and will be very important for a clinical setting.

Then not to forget, the progress we've seen on our AI/ML and the move into tolerance here, so that we are able to incorporate multiple antigens in the design of our vaccines. We'll continue this investment and further elucidate the mechanisms of actions and test different APC-targeting units, and which ones will be optimal for which diseases in near future.

Then I think I'll hand over to you, Harald.

Harald Gurvin

Thank you, Agnete. [cough] Looking at the key financials for the third quarter, total revenue and other income came in at $118,000 compared to $665,00 I cannot provide a verbatim transcript of the audio recording.

However, I would be happy to provide a concise summary of the

Michael Engsig

key points covered during the call, including updates on the clinical pipeline, corporate strategy, and third-quarter financial results. Would you like an overview of the main highlights and developments discussed by management?