Nykode Therapeutics As

Greetings, and welcome to the NICO Therapeutics Q3 2025 Financial Results Conference Calling 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 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 Ansig. Please go ahead, sir.

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 André Fredriksen, our Chief Scientific Officer and Head of Business Development, as well as co-founder, and Gorgon, our Chief Financial Officer. Just a quick recap on our company strategy, which we announced in Q3 this year, which really demonstrates our focus on our three core assets of ISUBA, formerly known as VB1016, which is our lead asset, and we're taking it into a randomized control cloud in Phase 2, and first line hit the neck. Secondly, we retain NEO, our individualized NEO antigen 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. And thirdly, our tolerance platform, which we are positioning as the best-in-class platform a 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, 2029. 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 Apsuva. 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 Pempolizumab from this trial, which also means that MSD has been part of writing the protocol and approving it in its current design. very happy and a great thanks to to the team for such a large effort um keeping this uh trial on progress on progress for a db10 neo program where we have started earlier that we are focusing on also strengthening the um the proprietary position around our neo select uh platform so the algorithm that selects targets that we incorporate into our 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 neo select platform which is a very important part of of protecting our exclusivity for this platform and 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 our leader will tell you more about that later today. We have presented a series of no 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. And we've recently also shown that we have the ability to modulate also the so-called funeral compartment, which means the antibodies And we are thus one of a very, very selected group of companies that can modulate all the compartments of the immune response. And we will also fill more of that in a couple of slides. Moving on to an update on Abesuva, and again, just to quickly remind everybody, Abesuva is our late 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. And 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 immune 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 OLR and oral survival. And we see also consistently a strong correlation between the effect and the immunogenicity, 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 ABDT 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 to 12 months. And we do also foresee that the ABDT trial itself should be able to deliver the first meaningful interim data within the next 24 months. So this is not a trivial indication, and we do see in particular with the head and neck, the HPV16-driven number of patients are increasing over the coming years. Alone in the head and neck, we see we are looking at an incidence of more than 60,000 patients per year. And 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 see more HPV-positive focused cell purification options for the future. And if we look at the forecasted market or estimated market for this segment, the HPV-16-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. The BGP trial is going to be the first time we take Abesuva into a randomized controlled 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 Abesuva plus Pembrolizumab, and the other one will receive Pembrolizumab, which is a standard of care. The primary endpoint will be ORR and PFF. This is the protocol as we expect it to look right now, such that we just submitted this to the authorities in the UK. I expect to submit to the EMA authorities imminently in December, and then begin the interactions with the authorities on the protocol and the stock design. Also, as I said before, I greet the supplier 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 expeditiously approved on the MSD side. Without that, we would not be able to run this trial forward, so grateful. Before handing over the word to Alena, I just want to remind you all here, Ability, our lead, moving into a randomized control trial setting for the first time, but 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're 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 entering readout of this trial within 24 months, which is within our cash runway. With those words, I'm going to hand over to Aline to take us through VB10 Neo.

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 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. So 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. And we have developed a proprietary AI algorithm in order to select the optimal neoepitopes per patient. And we have shown that these prioritize the 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 knee antigen therapies. There are 10 ongoing randomized clinical trials from peers, phase two and phase three trials. So this is really the highest investments in this field to date. And many of these will read out within the next 15 months, which we know will be very important and, if possible, further validate the concept of individualised knee enhancement therapies, which will bring VB10U 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. So 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 made 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 continue the competitiveness, increase the competitiveness. So here are data that we presented at the CC conference earlier this month, which we believe is very validating for the neoethicope selection method that we developed here in-house. When we select epitopes per patient, we select up to 20 new epitopes. So that's the number you see also up to 20 on the x-axis of the graph here to the left. And 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. And 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. So you can see there. once we rank as number one, also tend to be the optimal neoepitox. 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. So that's what we incorporate in what we call high-quality neoepitopes in the ones that make it into the vaccine design. And we see that these high-quality, immunogenic high-quality neoantigens are the ones that are mostly associated also with favorable clinical outcomes. Obviously, in patients with multiple different diseases and heterogenic patient populations, so needs to be further validated in future trials with very important signs going in the right direction here. And then, in order to solicit this, we have also very recently been granted another patent, another layer of protection for V-vitenio. which actually then focuses on the neo-epitope selection method that we have developed in-house. This is now in the US, and that is a patent that expires in 2039. So long protection here. This is a U.S. patent, so we have already previously been granted patents for the method of selecting the epitopes in Australia, China, Israel, and Japan, and Russia, which is going to be important for the future of Ibitenio. So 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 INPs. We do believe we are already in a good position, and we are continuing, as you also see here, with the NEO Select 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. And just as a background here, when we say tolerance, we are working with truly antigen-specific immune tolerance. And 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. So 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. So with antigen-specific immune tolerance, truly antigen-specific, we have a vision to offer a prospect or a cure, which you cannot envision with the current treatments. So 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'll also show you additional new data from the last quarter, both within long durability and in the EAE model as well as in the new model, VT-Ligo. And then we need to see regulation of all major auto-reactive disease-causing cells. So different autoimmune diseases, the reason for seeing disease can be caused by multiple different immune parameters, including autoantibodies, affected 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. 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. And obviously here also manufacturability and delivery, convenient delivery route is important here. So today I'll show you new data, basically in all of these boxes that are continuing to increase our convictions. So 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 are working on for multiple purposes. And we start to treat the mice after they have developed clinical symptoms and 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 And this is one of the things that 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 today. And this can be a very interesting, competitive advantage of our technology. We 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, 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 EIE model, where we see a reduction of an impact on the level of immune cells, so 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. And 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 organs as such. So 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 in and we have incorporated all the competence that we have developed over the years also from our individualized cancer antigen epitope selection and our core competencies here in the team in-house and 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. And our model was able to take 2.7 billion possibilities down to 39 selected antigens. And we can see that a high percentage of these is actually very functional with long, complicated sets of antigens is still being able to be produced in with high quality and high yield. And these are now being tested in in vivo trials. And this is also an important competitive factor where we don't see all our peers being able to incorporate multiple agents in one construct. Then for translatability into the clinic, we know most competitors are focusing or actually using intravenous delivery, which is complicated in the clinic. And 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. And 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. And 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 TRP2 antigen, and this is 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. So 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. We, to 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 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 phytoantibiotic-specific immune tolerance. It's both this long-lasting efficacy that we see now, but also the fact that we do observe an effect both on T-regs, 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 community-rural 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. And 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. So we'll continue this investment and further elucidate the the mechanisms of actions and test different APC targeting units and which ones will be optimal for which diseases in the near future. Then I think I'll hand over to you, Harald.

Thank you, Agata. Looking at the key financials for the third quarter, total revenue and other income came in at 118,000 compared to 65,000 in the third quarter of 2024. driven by less revenue from Genentech and Regeneral. 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. Financing 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 ground exposure. So 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 2020. 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. NICA 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 drafts of the recommendation from their secretariat in the first quarter of 2030. A positive outcome would push the cash flow into 2029. Moving on to equity and liabilities, we have total equity of 99 million, which represents a strong equity ratio of 94%. And with that, I will give the word back to Michael.

Thank you very much, Harv and Amir, and 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 infection points. Our cash runway has been extended thanks to a diligent approach to cost allocation or capital allocation. And you see the results on our quarterly costs this quarter compared to last year. which means our cash runway is still lasting into 28 slash 29 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 six 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 paying ourselves against. So we are working hard on strengthening positioning BB10-neo as the most attractive unencumbered INT field. And we, of course, will continue to see progress on our eighth 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 Abesuga in 2027. And there we also see a potentially continued readout from years 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. So, exciting times in front of 9code. And with those words, we'll be opening up for questions. So, 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 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 Geyer Holm. We do have a few questions from Geyer, from DMB 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, so thanks, Gaia, for your questions. And it's always filled with caveats to come with these kinds of projections for clinical trials like that. And 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. So correspondingly, if we want to be able to read out around the late summer of 2027, for example, we would need first patient coming in, the dose around summer time, 2026. That's just for modeling purposes. We are not guiding on exactly when we will do that, but that's 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, so here we are actually going in on the slightly... Aggressive or conservative, if you want a site, better open up too many sites to begin with. So 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. But 40 is the number of sites we currently estimate to open up. The majority of these will be across the UK and EMEA 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. But we will be providing more updates on that as we continue the planning. So for the first wave, as we have indicated, we are focusing on UK and EMEA. And then 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 a Question feature on your screen. Our next question is a follow-up from Kyra Holm from DMV Carnegie. Could you elaborate a little more on the supply agreement with MSD? Will print limit – excuse me. Pembalizumab be delivered free of charge with no strings attached?

It's always a good question what no strings attached means, but Pembalizumab will be delivered free of charge for ability. And, of course, there comes a commitment in terms of quality and safety surveillance and so on that we will need to deliberately take care of. But if you're thinking about any commercial obligations, we are not giving away any commercial rights to ABDT with this deal. So it is still a wholly owned NICODE assets going forward. But Pembolismo will be delivered free of charge for the ABDT trial.

Thank you. Our next question today is coming from George 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 you presented so many new data from that platform today, Georg. And it's a tricky question. When you say the most, I think I feel forced to say one thing. But I do think if there is one thing I'm most intrigued about now for being really competitive is that we do see this effect also on all the different levels of the immune response parameters, seeing these autoantibodies and The reason for saying that is that we haven't seen such data from peers. We also now see the effect on CD8 T cells with the LIGO models, which we also have not seen being published from peers. So I think in totality, the competitive strength is making us very optimistic at the moment. obviously on the back of sub-Q 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 characterize as unencumbered?

Well, 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. And basically almost all of them in adjuvant setting. We see Moderna moving a bit into first-line therapy as well. And all those pharma companies, they are both encumbered, both Moderna and BioNTech. They 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. We're all waiting 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. And again, thanks to all the participants listening in today. Thanks to Gaia and Gail for all your questions. And 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. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation today.