Greetings, and welcome to the Nykode Therapeutics Q1 2026 financial results presentation. At this time all participants are only listen mode. A Q&A session will follow the formal presentation. You may ask your question at any time by typing in to the "Ask your Question" feature on your screen. As a reminder this conference is being recorded. It's now my pleasure to turn the call over to Nykode CEO, Michael Engsig. Please go ahead, sir.
Thank you very much, Kevin. Also from my side, a very warm welcome to all our listeners to this, our first quarter webcast on this beautiful summer day in Oslo. Quick look at our forward-looking statements, which I think you are all familiar, but on that basis, we will move forward. As usual, it is a pleasure to have with me today, here, Agnete Fredriksen, our Co-founder, Chief Scientific Officer and Head of Business Development, as well as Harald Gurvin, our Chief Financial Officer. Who's taking you through the highlights of the quarter, a little bit deep dive into some of the data and of course the financial numbers also. For the new listeners, a very quick recap. Nykode is a clinical stage immunotherapy company focused on leveraging our Antigen Presenting Cell-targeted immunotherapy platform to discover new immunotherapies within oncology and autoimmune diseases.
Our lead asset is abi-suva, which is developing in first-line head and neck. We also have very high conviction in VB10.NEO, our individualized neoantigen therapy platform, as well as our autoimmune disease program. We're well capitalized with funding taking us into 2028, which is on the other side of all important inflection points. Been a busy quarter, with a lot of progress, in particular on abi-suva, but also interesting movement on our other programs. For abi-suva, we dosed the first patient in the randomized phase II trial, Abili-T, which marks the transition from preparation into execution. Of course, a very important milestone, which sets us on track to release the interim data in 2027. We also, at the ECR conference back in March, reported the interim data from the VB-C-03 part 1 trial, which also tests abi-suva in combination with KEYTRUDA pembrolizumab in first-line head and neck patients.
We'll take you through some of the data at a data point in this call here. We further elaborate some of the data at a presentation at the AACR one month later, which provided further conviction to our immunogenicity data. We've reported some progress on our autoimmune disease platform, showing the ability to also drive immune modulation in human cells. A very important point on our path towards a drug. We've showcased our activities in the AI accelerated drug design world at the Nexus conference. We'll just say a little bit about that, and we get to that in this presentation here. Brief update on abi-suva. As you know, we are currently focused on generating data from the first randomized trial with abi-suva. We've chosen first-line head and neck for several reasons.
One, it is a significant addressable patient population. Two, only one in five patients benefit from the standard of care. Even with a 12-month median overall survival, there is plenty of room for further improvement for this patient population. In addition to that, we see most of the drugs in development for first-line head and neck is focused on the HPV- patient population, whereas abi-suva is focused on the HPV+ patient population. There is further upside for abi-suva. In addition to head and neck, we see a very large addressable patient population in the other cancer types driven by HPV 16 infections, of which we have already generated very convincing data in the cervical cancer. We do see further significance upside for abi-suva in the future.
At the ECR conference, we show interim data, showing the overall from the 13 patients that was enrolled into the part 1 trial. The part 1 was focused at investigating three different doses of abi-suva, on top of standard of care, which is KEYTRUDA for this patient population. We reported an objective response rate of 39% in these 13 patients, which should be compared to what has been reported for the standard of care, so KEYTRUDA alone, which is around 19%. Close to a doubling or slightly more than a doubling, if you compare those two numbers. That corresponds very well to what we saw in the VB-C-02 trial where we investigated abi-suva on top of atezolizumab in the advanced cervical cancer setting. With those two trials, now we do see a strong trend towards an additive effect of abi-suva on top of checkpoint inhibitors.
Both at the ECR conference and subsequently at the AACR conference, we provided further details on the immunogenicity data, which we've always said is extremely important for any immunotherapy with the mechanism of action of abi-suva. We do need to see a strong correlation between the immune response to the antigens and the clinical outcome. What we see on this slide here is an ability to drive a very strong antigen-specific immune response towards the two targets, E6 and E7. We've just chosen to show you one slide. This one is probably the strongest slide showing the ability to drive this response in all patients dosed with 6mg or 9mg . Again, it aligns well with what we saw in the VB-C-02 trial when we tested this in cervical cancer patients. Further adds to the very strong trend we see with abi-suva.
All this data strengthens our conviction that Abili-T, a randomized phase II trial in first-line head and neck, is the right next step for abi-suva. Shown here on this slide is the design of Abili-T, as I mentioned, we have moved from the phase of starting up the trialing to execution. We are now approved in seven different EU countries, in addition to the approval we received in U.K. before year-end.
We saw the first patient dosed in May, we've already seen multiple sites being opened up and starting the search for patients. Our focus going forward is to expand the number of countries and sites for Abili-T, we can make sure we have the sufficient number of sites engaged to recruit the approximately 100 patients in a timely fashion. Everything is aimed at generating the first interim readout in 2027. With those words, I'll hand over to Agnete Fredriksen to take us through an update on VB10.NEO.
Thank you, Michael. Yes, in VB10.NEO, we have a laser focus on following the progress of our peers these days, getting closer and closer to expected readouts from both BioNTech and Moderna on their late stage, phase II, and most importantly, phase III randomized trials with their individualized neoantigen therapy. This will be extremely important for the future of our own VB10.NEO. We do believe our VB10.NEO meets the requirements for an ideal INT technology and has several advantages over the mRNA technologies that BioNTech and Moderna is pursuing. We are focusing on a cost-conscious base strengthening this position in a few key activities on VB10.NEO program as we speak. In this quarter, we have focused on the antigen selection part with our proprietary NeoSELECT, and also on continuing to improve the supply chain.
We'll give you more details on the progress there in the next coming months, including our participation and presentation at the ninth International Neoantigen Summit in July. You can follow the progress in more detail when we come to this conference. Some updates on the tolerance program. Over the last year, we've seen numerous highlights on why we want to pursue an antigen-specific immunotherapy program with our APC-targeted technology. We have been able to show strong durable efficacy across disease models. We are constantly improving the number of disease models, and we see that on both in a therapeutic and preventative setting.
Today, I'll show you a bit more detail on the modular APC-targeted platform. How using different APC-targeting units allows the immunotherapy to get into different cell types and process in different efficiency presented to regulatory T cells. Also proliferating those regulatory T cells in a different manner, depending on our unique proprietary APC technology. We have also seen unprecedented induction of both this proliferation of the antigen-specific regulatory T cells. Importantly, the next step in the cascade suppression of effector CD4 and CD8 T cells. Also an effect on reducing autoantibodies, importantly. One of the key features that is important for taking this into the clinic and to a commercial setting is to be able to have a convenient delivery. Also favorable safety profile, in addition to have a technology that can be manufactured as a standard biologic.
We are having a technology that's a fusion protein that can be manufactured through very standard antibody manufacturing procedures, which is reducing the risk for taking this from pre-clinic to the clinic, as we are seeing now also with our CMC efforts in this program. Today, we'll also see a bit more on the human APC translational data that supports that we do have a path from pre-clinic to clinic that could be pretty effective when we take that choice. Obviously, it's important for everyone that this technology is being developed as a second program in Nykode on the back of a technology that's been clinically validated in oncology. You've seen this mechanism of action figure before, and how our APC targeting is able to induce regulatory T cells and reduce effector B and T cells. Today, we will focus mostly on the human translational potential.
See that we have now created human versions, where we have human targeting units binding to human APCs, which is the first step of the mechanism of action here in the red figure. Subsequently, these vaccine molecules are taken up by the antigen-presenting cell process and epitopes presented on MHC molecules to regulatory T cells, which you also see today. We have set up a system that nicely shows us how effective this is going through the antigen-presenting cell, which we can use in order to identify the optimal human versions of the APC targeting units for clinical use. Thirdly, these regulatory T cell proliferation, which I will show you here. Here on this slide, you can see that we have now made human versions of our molecules that bind to human antigen-presenting cells.
When we compare that to non-APC-targeted version, we can clearly see that we have molecules now that bind to human antigen presenting cells. This is how you see on the figure that it's shifted to the right on the figure. That means that our therapies are binding relevant cells. For the right part of this figure, the sophisticated setup, where we have looked at how much of the disease epitopes are actually presented on the MHC molecules after the entire molecule has been taken up, processed, and presented, and how much of this is actually then available to be presented to regulatory T cells. It's the same method, so you can see that if the shapes are shifted to the right, you will have more and more of these effective antigen presentation on antigen-presenting cells.
At the end, as you can see, the targeted APC-targeted therapy is strongly presenting the antigens to regulatory T cells on the HLA class II antigen complex that we measure here. It means we are getting closer and closer to have clinically ready drugs. Another important factor of our technology is that depending on which APC targeting unit that we are employing in our molecules, we will have a different effect on the immune system. In this particular system here, we can measure that if we use here a variety of five different APC targeting units that all look the same when it comes to the disease-relevant antigens, we can see that these five APC-targeted molecules are inducing a different proliferation of regulatory T cells, and much better proliferation on these regulatory T cells than the non-targeted version.
The percentage of those that are truly FOXP3 regulatory T cells differs between the different versions of our technology. All of these methods gives us more and more insight into how precisely we can modulate the immune system and choose a version of our platform that will be ideal in order to treat a particular autoimmune disease. All of these are proprietary to Nykode, and you can also appreciate that we have a technology that can extremely precisely modulate which cell types that will be triggered for each patient here. I think I'll hand on to you, Michael, to give us some insights on the AI.
Thank you very much, Agnete. One of the questions we get most often from investors and analysts is how we are using AI and machine learning to drive the results in our work with the new therapies at Nykode. The truth is that we've been using AI and machine learning for a very long time, all the way going back to when we started the VB10.NEO program. AI and machine learning is a fundamental part of our VB10.NEO program. It helps us select the right neoantigens. In fact, it is one of the core competencies or core assets of our NeoSELECT platform, as we have mentioned a couple of times.
For us, machine learning and AI have been an integral part of the company for close to 10 years now, which is probably also the reason why we've been remiss at communicating what we do in this area in Nykode. Now that we had a presentation at the Nexus conference showcasing some of our work, we thought we would also take the opportunity to provide a little bit of an insight at this webcast here. We will very likely be giving further insights into how we use AI over the coming months, including also on the update on VB10.NEO at the International Neoantigen Summit during summer. As I said, AI is a fundamental part of our VB10.NEO program. We've been using that to optimize each and every construct we've developed.
We've been using it to train the algorithm and the NeoSELECT to select the right ones, the right targets for each patient. Based on the learnings we generated with NeoSELECT, we have also taken that forward into our tolerance program, as well as implemented new tools, new available tools, which means we use AI both in the way we design the construct, but also to speed up the candidate screening and selection, which means we get better constructs, and we get them much faster and much cheaper. Wherever we use AI to optimize our work, we always have our senior scientists sit in and do the human oversight, what we call human-in-the-loop oversight, to make sure that the scientific rigor is never compromised in the work we do.
This is specifically for our programs, but we are also using AI across the company, also in the non-research and development-related functions, focusing on building up AI literacy across Nykode. Everybody is using AI frequently now. We are using it both to increase the knowledge sharing across the organization, but also to speed up our work processes and facilitate meeting flow, decision-making, and meeting. Do feel ourself as a very AI-capable organization. We will continue to explore this area, leverage all tools available, and of course, keep you updated on how we use this as a fundamental part of our programs in the future. With those words, I will hand over to Harald to take us through the financial results.
Thank you, Michael. Looking at the income statement, other income of $240,000 for the first quarter relates to government grants. Employee benefit expenses for the quarter were $2.9 million, compared to $3.7 million for the same period in 2025, reflecting a reduction in the organization. Finance income and costs were a net $2.4 million positive in the quarter, which mainly relates to interest income and unrealized currency movements on Norwegian krone exposure. The reduction in income tax is due to a shift during 2025 from a deferred tax liability to deferred tax asset position, which in accordance with IFRS, is not recognized in our account. Overall, we record a net loss of $4.1 million for the first quarter, compared to a net loss of $1.4 million for the same period in 2025. Moving on to the balance sheet.
We are still well capitalized with a cash position of $51.3 million at the end of the first 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 $33.3 million at the end of the first 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. According to the Secretariat and the Tax Appeal Board, they have started working on the case, although slightly delayed compared to the letter we received earlier this year due to their caseload. We can now expect a draft recommendation from the Secretariat latest in July, which we then expect to communicate to the market.
The updated timeline would indicate the final outcome in August or September this year, but we understand from our advisors that the draft recommendation will serve as a good proxy for the final outcome. A positive outcome would push the cash runway into 2029. Moving on to equity and liabilities. We have total equity of $ 87.5 million, which represents a strong equity ratio of 93%. With that, I will give the word back to Michael.
Thank you very much, Harald. Just to finish off before we open up for questions with the outlook, reminding everybody we are very well capitalized with a runway that takes us past a number of very important inflection points. Our focus for the next 12 months is obviously on the execution of Abili-T. Expanding the number of countries and sites involved in the Abili-T, making sure all investigators are motivated and searching for the patients that we need to be enrolled in this trial. We also do expect, according to the guidance we have received from our peers, to see key peer readouts from individualized immunotherapy therapies. In particular, we are looking forward to see the data from the phase III trial of Moderna and melanoma. Of course, we will be looking forward to see continued progress on our autoimmune disease platforms, called the APC platform.
A little bit longer, we are focusing on being ready for the first interim analysis by Abili-T in 2027. We do expect to see a continued string of peer readouts within the individualized immune engineering therapy as we progress through 2027 and into 2028. Interesting times ahead of Nykode, and with those words, I think we can open up for questions, Kevin.
Yes, sir. 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 "Ask a Question" feature on your screen. Once again, if you'd like to ask a question at this time, please type your question into the "Ask a Question" feature on your screen. Our first question today is coming from Geir Holom from DNB Markets.
How should we think about the level of market communication about the pace of patient recruitment going forward? Could you elaborate on the recruitment dynamics you are currently seeing at the clinical sites, particularly in terms of the pool of eligible patients and the level of competition from other ongoing trials?
Yes, thank you very much for that question, Geir. We obviously will, as usual, be using the quarterly webcast here to update on progress for Abili-T. I think that is the level of detail we will be providing. We did announce the first patient in, as is usual for a biotech company like ours, but don't expect us to keep announcing in between numbers on patient enrollment. We will be updating you at the quarterly results. In terms of recruitment dynamics and the competition for patients, I think it varies across countries. We do see some countries where there is not too many trials going on with this patient population, and we see trials where the competition is slightly higher.
Head and neck is traditionally a quite competitive area, we mainly see the competition in the segment called the HPV- patient populations, which is specifically the ones we are not targeting with abi-suva. The competitive situation in the HPV+ head and neck patient segment looks slightly more favorable for us. As I said, there are countries where we do see competition. The obvious main competitor for Nykode right now in terms of patient recruitment is the ongoing trial from BioNTech, also searching for the same patients as we are. Our understanding is that that trial will be finalizing enrollment in not too distant future. I think we can take the next question.
Certainly. Our next question is a two-part question. I will ask them in two separate parts. From Georg Tigalonov-Bjerke from ABG Sundal Collier. He says,
Thank you for taking these questions. Could you please elaborate on whether the delay related to the pending tax case reflects any substantive feedback or request from the Norwegian Tax Administration, or rather a procedural issue related to processing times within the public system?"
Thanks, Georg. No, our understanding is that this is purely procedural issue due to the case load they have and also the priorities they have to make according to law. No other reasoning than that.
The second part of their question is, regarding Abili-T, could you please elaborate on the latest planned geographical footprint, specifically how many clinical sites and how many countries you're currently targeting in total? He wishes best regards.
Again, also, Georg, thanks for these questions here. We are right now, as I said, open in eight countries. All of them are in Europe. We very likely will be opening up somewhere between two to three additional countries. At least that's our plan right now. The projections that we have, which is based on data from other similar trials, tells us that we will need somewhere between 40 to 45, 50 sites to enroll within the two-year timeframe that we've given ourself. That's the number we are aiming for, probably going up towards 50. Those of you who are familiar with clinical operations know that not all 50 sites will be enrolling. It's a rule of thumb that says that 20% of the sites will be enrolling the 80% of the patients.
If there was a way to find the 20% of sites, of course, that would be easy. In order to get those 20%, you usually need to ensure a little bit over the target. That's why we are aiming for probably up towards 50 sites into this trial here. I see, Kevin, we have received some questions in Norwegian, and I think I will try to read those. This is a question from Erik Hofland. First question is, how many patients we expect to have recruited by the end of 2026? What is the biggest bottleneck? We have not given guidance on a patient number by the end of 2026, but we have guided that we aim to provide an interim analysis based on one-third of the patients some 12 to 15 months after first patient enrolled.
Assume that'll be slightly into the H2 of 2027. That means recruiting at least the 1/3 of the patient number there. We do intend to enroll up towards 100 patients into this trial here. Second question from Erik is, how would we rate a clinically meaningful result from this trial here? I fully get the intention with the question, but it is extremely difficult to simplify the success criteria of a trial like Abili-T into one single number. Success is a very nuanced field. There is the clinical effect, which is measured in terms of progression-free survival and objective response rate, ultimately overall survival. There is the safety questions. There is tolerability. There is immunogenicity. Success will mean a good outcome on each of these scores. It is very difficult to simplify the answer here.
A good rule of thumb is you used to want to see at least 15 basis points increase on the objective response rate. Whether that is still a golden rule going forward is probably a good question. At least if we take the data we have seen in the VB-C-03 trial, if we would be able to replicate something that looks like what we saw in VB-C-03 part one, we would be extremely happy. Combined, as I said, with a good outcome on ORR, progression-free survival, a strong immune response correlated with a clinical outcome and a continued favorable safety profile as we saw from the interim VB-C-03 data. Just need to see the next question. This is a question for you, Harald. Should we use Q1 as a normal level for the cost going forward?
Thank you. I think if you look at the guidance we've given, we started out the year with just over $60 million in cash, we've guided into 2028, that's roughly $7.5 million per quarter against a cash flow of roughly $10 million in the first quarter. It will fluctuate a bit depending on progress on the trial. If you look at this quarter, we had some prepayments related to startup of the Abili-T trial, roughly $2 million just on that, which is also reflected in the other receivables, which went from $1.6 million per year-end to $4 million per the end of the quarter, which reflects prepayment for services under Abili-T trial. It will fluctuate a bit depending on the trial, but it should be less in some quarters and maybe the same in other quarters.
Very good. Thank you very much, Harald. Last question from Erik is, I think that's a question for you, Agnete. When do we think the partnering interest for abi-suva will be concrete or solid enough? Is that going to be before or after the Abili-T interim data?
As I think like partnering and partnering interest is a continuous process, and the more data that we generate, including the interim data from VB-C-03, is continuing to support partner negotiations. Obviously, Abili-T first randomized data indicating a delta between the KEYTRUDA on the arm and the KEYTRUDA abi-suva will be very important for partners in that respect. We are having a lot of discussions with partners moving towards that first next big inflection point that we have internally. As a third aspect for partners is also key data. Everything from other cancer vaccines, including the individualized neoantigen therapies, whether they are successful or not, has an impact on other pharmas as to their interest in the cancer vaccine space broadly, and not necessarily only for the VB10.NEO program.
We have a couple of peers that are also pursuing an HPV 16 specific immunotherapy and expecting, for instance, some readout from BioNTech's program in that respect later this year. Both positive and negative data can have a positive impact on the partnering interest from our peers. As long as we are differentiated, we can also receive increased interest with negative BioNTech data, and positive BioNTech data is also supportive for our program with our differentiation. Multiple potential steps are coming in the near future that can continue to build the partnering.
Thank you very much. I think, Kevin, we are ready to move on to the next one.
Certainly. 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 set of questions today are coming from Luis Santos from H.C. Wainwright & Co.
I'll ask them in several parts. The first part is, both 6mg and 9mg were safely cleared and both delivered 100% HPV 16 specific T cell response rates. Given the single transient grade 3 rash DLT at 9mg and the comparable immunogenicity at 6mg , what is the rationale for the dose or doses carried into Abili-T? Are you taking 9mg forward as a single RP2D or running a dose comparison in the randomized portion to de-risk a future label?
From all objective parameters, as we've looked into the details of both safety, clinical responses, immunogenicity, durability, and everything in this VB-C-03 trial, it is obviously it's a very safe product. Basically, we cannot say that there is any safety difference between the different doses as we see it. There's basically very similar clinical responses. There is a tendency to higher immunogenicity, in the 9 mg versus the 6 mg. It's very standard to move forward with the highest dose that is safe for the patient. Including also, you may have seen at ICHNO, a patient case of a 9 mg patient that has a quite remarkable clinical response. We are moving forward with the 9 mg dose as a single dose but compared to KEYTRUDA chemotherapy.
Very good. The next question.
The next question from Luis Santos at H.C. Wainwright is: What is the prioritized lead indication for the next VB10.NEO trial? What is the proposed design, single arm, registrational randomized versus SOC and CPI, perioperative, adjunctive and versus metastatic? What specific efficacy bar ORR, PFS, MRD- or RFS would unlock the next clinical step?
Thank you very much for that question, Luis. I'd like to think we have been very clear on our strategy with VB10.NEO, reflecting that the capital need to run any clinical trials in the individualized neoadjuvant therapy space would be very significant. We have chosen a strategy where we will focus on holding the technology right now, both in terms of looking for potential platform improvements, as I may have described earlier in this call here, as well as making sure we have a locked and ready-to-go clinical and supply setup. In other words, to position ourselves as the most attractive unencumbered, individualized neo-adjuvant therapy assets out there, ready to leverage any potential positive data coming out of, in particular, as we said, Moderna's ongoing phase III trial for melanoma space.
That means that it is not our plan to take VB10.NEO into a clinical trial on our own right now. What the trial would look like if we found a partner and the partner decided to go into a clinical trial would of course be subjective to good discussions with such a partner. We, of course, will come to such discussion with strong opinions and insight. We of course welcome any dialogue with a future partner on where to focus the design. I think we've been pretty clear that we think VB10.NEO in particular belongs into an earlier stage patient population, addressing locally advanced adjuvant setting rather than going into heavily pretreated hard to treat patients with heavy tumor burdens. That's just how we see the space of IMT right now.
If we can move to the next question.
Certainly. Our next question from Luis Santos from H.C. Wainwright.
On your ASIT platform, are BD discussions active? What stage are they at? What economic structure are you targeting? If partnering on ASIT is delayed, would you self-fund through FIH or pause progression?
Yeah, thank you, Luis. As you may know, the field is a very interesting field. Autoimmunity has caused a lot of focus with pharma these days, there is a lot of progress on more and more specific drugs for this patient group that is in high need of something that does not necessarily also require a chronic treatment, and actually doesn't only take care of the symptoms, but can potentially cure the patients. We do see a lot of interest from pharma in this program. There is nothing we can disclose when it comes to financial structures or how we would prefer to set up such a collaboration if we decide to pursue such a collaboration.
The next step for us now, as you may have followed our preclinical progress on the platform, we are getting closer and closer and maturing in defining all our unique selling points with our technology compared to other antigen specific immunotherapy technologies, which also enables us to make a decision on how to best take this forward towards clinical use. An important next step for us is a strategic review with the board, in August, where we will define how to take this program forward in the next period. Thank you.
Thank you. We've reached the end of our question and answer session. I'll turn the floor back over for any further closing comments.
Thank you very much from us to all our listeners and for the questions. It is always good to meet you at this occasion here. Looking forward to keep you updated and wishing you all a good, warm, and successful summer. Thank you very much.
Thank you. That does conclude today's Nykode Therapeutics webcast. Let me just connect your line out at this time and have a wonderful day. We thank you for your participation today.