Earnings call transcript: Nykode Therapeutics Q3 2025 shows reduced losses

Nykode Therapeutics reported its third-quarter 2025 earnings, highlighting a significant reduction in net losses compared to the previous year. The company’s stock saw a modest gain, climbing 2.08% to a closing price of $2.12. Despite a decrease in total revenue, Nykode managed to cut operating expenses considerably, extending its cash runway to 2028-2029.

Key Takeaways

• Net loss improved to $3.7 million from $9.7 million in Q3 2024.
• Operating expenses were reduced from $15.6 million to $6.4 million.
• Cash position remains strong at $64 million, with a potential $32.5 million from a pending tax case.
• Ongoing development of three core assets in cancer and autoimmune disease treatment.

Company Performance

Nykode Therapeutics demonstrated resilience in Q3 2025 by significantly reducing its net loss and operating expenses. The company’s strategic focus on streamlining operations and disciplined capital allocation has positioned it well for future growth. Despite a drop in total revenue to $118,000 from $665,000 in the same quarter last year, the company managed to extend its cash runway until 2028-2029, providing a stable financial foundation.

Financial Highlights

• Total revenue: $118,000 (down from $665,000 in Q3 2024)
• Net loss: $3.7 million (improved from $9.7 million in Q3 2024)
• Operating expenses: $6.4 million (down from $15.6 million)
• Cash position: $64 million

Outlook & Guidance

Nykode is focusing on advancing its core assets, particularly in the cancer and autoimmune disease markets. The company plans to conduct a randomized phase two trial for its lead asset, AviSuva, targeting HPV16-driven cancers, with interim data expected by the first half of 2026. Additionally, Nykode’s individualized neoantigen therapy, VB10.NEO, has received a U.S. patent for its NeoSelect platform, positioning it as a leading unencumbered asset in the field.

Executive Commentary

Michael Engsig, CEO of Nykode, emphasized the company’s strategic positioning, stating, "We are positioning this as the most attractive, unencumbered INT assets." Chief Scientific Officer Arnold Fredriksen added, "We have a vision to offer a prospect of a cure," highlighting the company’s commitment to innovative treatments. Engsig also noted the extended cash runway, attributing it to disciplined capital allocation.

Risks and Challenges

• The company’s reliance on successful trial outcomes for future growth.
• Potential delays in clinical trials could impact timelines.
• Market competition in the cancer and autoimmune therapy sectors.
• Dependence on favorable outcomes in pending tax cases for additional cash inflow.

Nykode’s strategic focus and operational efficiency have provided a strong foundation for future growth, despite challenges in revenue generation. The company’s innovative approach in its core therapeutic areas remains a key driver of its long-term strategy.

Full transcript - Nykode Therapeutics ASA (NYKD) Q3 2025:

Kevin, Conference Call Moderator: 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, CEO, Nykode Therapeutics: 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 such statements, we will move ahead. As usual, it’s my pleasure to have next to me here Arnold 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: AviSuva, formerly known as VB10.16, which is our lead asset, and we’re taking it into a randomized control trial in phase two and first-line head and neck. Secondly, VB10.NEO, our individualized neoantigen therapy with the potential to basically be a future therapy towards all cancer types.

We’re positioning this as the most attractive, unencumbered INT assets, ready to leverage peer data. Thirdly, our tolerance platform, which we are positioning as the best-in-class tolerance platform for treatment of autoimmune diseases, potential 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 this month is the Ability trial, our randomized control trial for AviSuva.

We are very happy to announce that we have submitted the protocol to the U.K. authorities in November, and we are expecting a submission to the EMA authorities imminently, which is, to be honest, 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 has 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 targets that we incorporate into our vaccines on a patient-by-patient basis. We have 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. Arnold will tell you more about that later today.

We have presented a series of null 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. We are thus one of a very, very selected group of companies that can modulate all the compartments of the immune response. Arnold will also tell you more about that in a couple of slides. Moving on to an update on AviSuva. Just to quickly remind everybody, AviSuva is our lead candidate. It’s a therapeutic immunotherapy developed against HPV16-driven cancers. We are moving this asset into a randomized controlled phase two trial in first-line head and neck.

We are 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 immuno checkpoints, and one is a monotherapy. We see consistent added benefits 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 do consider a pivotal thing for a cancer vaccine to show credible data. The next step for this is, as I said before, initiating the Ability trial, the randomized control trial, which will be enrolling up to 100 patients. We also expect to release the first interim data from the ongoing CO3 trial within the next 6-12 months.

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. We do see, in particular with the head and neck, the HPV16-driven number of patients 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 do not 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 segment, 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 AviSuva into a randomized control setting. It’s technically a phase two trial with us expect to enroll up to 100 patients split into two groups, randomized one-to-one. One group will receive AviSuva plus pembrolizumab, and the other one will receive pembrolizumab, which is a 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 the U.K.

I expect to submit to the EMA authorities imminently in December and then begin the interactions with the authorities on the protocol and the start of design. Also, as I said before, I agreed to the supply of pembrolizumab with MSD. I here would like to thank the colleagues at MSD for their very gracious help on getting this trial designed and expeditedly approved on the MSD side. Without that, we would not be able to run this trial forward. Grateful. Before handing over the word to Arnold, I just want to remind you all here, Ability, our lead asset, moving into a randomized control trial setting for the first time. We are expecting to deliver the interim data from CO3 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 Arnold to take us through VB10 Neo.

Arnold Fredriksen, Chief Scientific Officer and Head of Business Development, Co-Founder, Nykode Therapeutics: Thank you, Michael, for the little reminder of where we are at the moment with VB10 Neo. We have performed two clinical trials with this fully individualized cancer neoadjuvant 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 seven-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 neoadjuvant therapies. We have developed a proprietary AI algorithm in order to select the optimal neoepitopes per patient. We have shown that these prioritize the superior immunogenic neoadjuvants from the two clinical trials, as well as preclinical data. In the future, we see now a very interesting defining period for individualized neoadjuvant therapies. There are 10 ongoing randomized clinical trials from peers, phase two and phase three 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 possible, will further validate the concept of individualized neoadjuvant 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 our focus today with some progress that we’ve seen in this particular box for the last quarter. We are currently also working even more on the supply chain and the cost of goods in order to continue the increase in competitiveness.

Here are data that we presented at the CITSI 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 epitopes per patient, we select up to 20 neoepitopes. That’s the number you see also up to 20 on the x-axis of the graph here to the left. We rank these epitopes, and the 20 best epitopes will make it into the vaccine and 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 there, once 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, NICO has focused on not only incorporating features that are linked to immune responses against the neoantigens, but also technical and clinical parameters. That is what we incorporate in what we call high-quality neoepitopes in the ones that make it into the vaccine design. We see that these high-quality immunogenic, high-quality neoantigens are the ones that are mostly associated also with favorable clinical outcome. Obviously, in patients with multiple different diseases, the heterogenic patient population needs to be further validated in future trials with very important signs going in the right direction here.

In order to solicit this, we have also very recently been granted another patent, another layer, our protection for VB10 Neo, which actually then focuses on the neoepitope selection method that we have developed in-house. This is now in the U.S., and that is a patent that expires in 2039. Long protection here. This is a U.S. patent, so we have already previously been granted patent for the method of selecting neoepitopes in Australia, China, Israel, 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. I think I’ll move into the tolerance program. Just as a background here, when we say tolerance, we are working with truly antigen-specific immune tolerance. This is a really new way of thinking about autoimmune disease treatment. The problem of today’s treatment 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 affect a huge portion of our global population.

It’s actually 1 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. Today, I’ll also show you additional new data from the last quarter, both within long durability in the EAE model as well as in the new model with the LIG model. 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, affected T cells, CD8, CD4. 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. Many 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 was 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, a 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 an 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.

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 a 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.

Another sophisticated data here that we are pretty proud of is that we have, to the left, been able to look into the central nervous system or the 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 an 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, the 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 at type 1 diabetes project, where we could identify multiple antigens and multiple opportunities to combine these antigens in one construct. Our model was able to take 2.7 billion possibilities down to 39 selected antigens. We can see that a high percentage of these is actually very functional with long complicated sets of antigens still being able to be produced with high quality and high yield. These are now being tested in in vivo trials.

This is also an important competitive factor where we do not see all our peers being able to incorporate multiple antigens in one construct. 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. As the last data slide here, we have, as I mentioned initially, now moved into a third, the disease model. Initially here, looked at with the LIG model, where we can induce the disease with a human TRP2 antigen.

This is driven by CD8 T cells. 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 today shows 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 a sum up, we feel more and more confident with the data we’re generating and our path towards developing the best-in-class antigen-specific immune tolerance platform. We’ve seen a lot of progress from the last quarter here, and the team is 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 is 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 Treg’s, CD8 T cells, and autoantibodies. 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, subQ, as I showed here today, which makes this the hurdle less to move into the clinic and will be very important for our clinical setting. Not to forget the progress we’ve seen on our AIML 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 the near future. I think I’ll hand over to you, Harald. Thank you, Agnete. Looking at the key financials for the third quarter, total revenue and other income came in at $118,000, compared to $665,000 in the third quarter of 2024, driven by less revenue from Genentech and Regeneron. Total operating expenses reduced from $15.6 million in the third quarter of 2024 to $6.4 million in the third quarter of 2025, reflecting the reduced organization following the organizational streamlining finalized in the first quarter of 2025, and also reduced clinical activities. Finally, income and costs were net $1.3 million positive in the third quarter, which mainly relates to interest income and unrealized currency movement on Norwegian krone exposure.

Overall, we recorded a net loss of $3.7 million for the third quarter compared to a net loss of $9.7 million for the same period in 2024. Moving on to the balance sheet, we are still well capitalized with a cash position of $64 million at the end of the third quarter. 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 $32.5 million at the end of the third 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 tax experts.

As communicated in the first quarter, we have received a letter from the tax authorities that we can expect a draft of the recommendation from their secretariat in the first quarter of 2026. A positive outcome would push the cash runway into 2029. Moving on to equity and liabilities, we have total equity of NOK 99 million, which represents a strong equity ratio of 94%. I will give the word back to Michael. Thank you very much, Harald and Anita. Just recapping here before we open up for questions. With the initiatives that we have taken on the cost base and restructuring, as well as the progress we are seeing on the programs, we feel the company is very well positioned to execute on our strategy and meeting our inflection points.

Our cash runway has been extended thanks to a diligent approach to cost allocation or capital allocation. You see the results on our quarterly costs this quarter compared to last year, which means our cash runway is still lasting into 2028/2029 on those presumptions Harald just mentioned, which again means that it exceeds the meaningful inflection points we see in front of us. Within the next 6 to 12 months, our focus is on getting the interim efficacy data from the CO3 trial, which we expect to be able to announce somewhere in the first half of 2026. We may also be looking at key peer readouts from the individualized neoantigen therapy field, which could, of course, also drive interest in the field as a general, and that is what we are pegging ourselves against.

We are working hard on strengthening positioning VB10 Neo as the most attractive and uncommon INT in the field. We, of course, will continue to see progress on our AIS platform, positioning that as the best-in-class platform. If we look a little bit further out into the future, we should be looking at the first interim data from our Ability trial, the randomized control trial in AviSuva in 2027. There we also see a potential continued readout from peers in the individualized neoantigen therapy field. In particular, here we’ll be looking at some of the first randomized control phase three trials reading out. Exciting times in front of Nykode. With those words, we’ll be opening up for questions. Kevin, will you take us through those? Certainly. We’ll now be conducting a question and answer session.

If you’d like to ask a question at this time, please type your question into the asked question feature on your screen. Once again, if you’d like to ask a question at this time, please type your question into the asked question feature on your screen. Our first question today is coming from Geir Holm. We do have a few questions from Geir from DNB Carnegie. The first one is, you expect to report the first interim efficacy analysis in 2027. To deliver on that, when must you start dosing your first patients? Yeah. Thanks, Geir, for all your questions. It’s always filled with caveats to come with these kinds of projections for clinical trials like that. As you know very well, a lot of uncertainties. Our planning right now assumes a little bit more than a year from first dosing to the interim readout.

Correspondingly, if we want to be able to read out around the late summer of 2027, for example, we would need to be able to see the first patient coming in and be dosed around summer time 2026. That is just for modeling purposes. We are not guiding on exactly when we will do that, but that is just for your modeling purpose. Okay. A follow-up from Geir is, how many clinical sites do you plan to open, and will all sites be in Europe? Yeah. Here we are actually going in on the slightly aggressive or conservative, if you want, side and saying we better open up too many sites to begin with. Our current planning is to open up 40 sites in the Ability trial. Our modeling tells us that should be enough.

We will, of course, be monitoring this closely and react if we see we need to open up more sites. Forty is the number of sites we currently estimate to open up. The majority of these will be across the U.K. and EMA region in Europe, but we are looking at regions outside Europe also. One of the countries that I myself feel very compelled to also explore is, of course, Canada. We will be providing more updates on that as we continue the planning. For the first wave, as we have indicated, we are focusing on the U.K. and EMA. We will be considering further countries as a second wave in the beginning of the new year. I think we can take the next question, Kevin. Sure.

Just as a reminder, if you’d like to ask a question today, please type your question into the ask question feature on your screen. Our next question is a follow-up from Geir Holm from DNB Carnegie. Could you elaborate a little more on the supply agreement with MSD? Will pembrolizumab be delivered free of charge with no strings attached? It’s always a good question what no strings attached means. Pembrolizumab will be delivered free of charge for Ability. Of course, that comes with commitments in terms of quality and safety surveillance and so on that we will need to diligently take care of. If you’re thinking about any commercial obligations, we are not giving away any commercial rights to Ability with this deal. It is still a wholly owned Nykode asset going forward. Pembrolizumab will be delivered free of charge for the Ability trial.

Thank you. Our next question today is coming from George Tillonov Bjorky from ABG. He says, "Hi, and thank you for taking his questions." Which recent data point reinforces your conviction in the platform’s long-term value the most? I will assume you are referring to the tolerance platform since we presented so many new data from that platform today, George. It is a tricky question. I assume when you say the most, I think I feel forced to say one thing. I do think if there is one thing I am most intrigued about now for being really competitive, it is that we do see this effect also on all the different levels of the immune response parameters. We are seeing these autoantibodies. The reason for saying that is that we have not seen such data from peers.

We also now see the effect on CD8 T cells with the LIG model, which we also have not seen being published from peers. I think in totality, the competitive strength is making us very optimistic at the moment. Obviously, on the back of subQ delivery and multi-antigens, which are also important for actually being the one that will succeed in the end. Now I’m not allowed to say more, I think. Next question, Kevin. Yep. We do have a follow-up from George. Regarding discussions with potential partners for VB10 Neo, have you noticed any change now that it is entirely under your control again and characterized as unencumbered? Yeah, definitely.

We have a lot of interactions now with pharma companies, and there is this period where we do observe the pharma companies paying a lot of attention to when and how the data will read out from our peers that are doing randomized clinical trials these days. Basically, almost all of them in adjuvant setting with Moderna moving a bit into first-line therapy as well. All those pharma companies, they are both encumbered, both Moderna and BioNTech, that are doing the vast majority of these trials. We do have a lot of interactions from pharma companies these days now that we are free or unencumbered waiting. We’re all waiting eagerly to see how the data will pan out. Thank you. We’ve reached the end of our question and answer session. I’d like to turn the floor back over for any further closing comments.

Thank you very much again, Kevin. Again, thanks to all the participants listening in today. Thanks to Geir and Geir for all your questions. With those words, I think we’d like to wish you a good day and see you next time. Thank you. That does conclude today’s teleconference and webcast. Let me just stretch our lines at this time and have a wonderful day. We thank you for your participation today.

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