Nykode Therapeutics As

Greetings, and welcome to the NICODE Therapeutics Q1 2026 Financial Results Presentation. At this time, all participants are in listening 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 NICODE CEO, Michael Engsig. Please go ahead, sir.

Thank you very much, Kevin. And 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. A quick look at our forward-looking statement, which I think you are all familiar. On that basis, we will move forward. As usual, it is a pleasure to have with me today, Anita Fredriksson, our co-founder, chief scientific officer, and head of business development As well as how our chief financial officer. Taking you through the highlights of of the quarter that the deep dive into some of the data and of course, the financial numbers also. So, for the new listeners, a very quick recap, my code is a chemical stage immunotherapy company. focus on leveraging our antigen-presenting cell targeted immunotherapy platform to discover new immunotherapies within oncology and autoimmune diseases. Our lead asset is Abisuba, which we are developing in first-line head and neck. But we also have very high conviction in EB10neo, 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. It's been a busy quarter with a lot of progress, in particular on Abhisuva, but also interesting movement on our other programs. For Abhisuva, we dosed the first patient in the randomized phase two trial ability, which marks 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 ICMA conference back in March, reported the interim data from the CO3 part one trial, which also tests Abesuga in combination with Keytruga or Pembrolizumab in first-line head and neck patients. will take you through some of the data at a later point in this call here. We further elaborated some of the data at a presentation at the AECR 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. And then we've showcased our activities in the AI accelerating 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 Abizuga. As you know, we are currently focused on generating data from the first randomized trial with Abizuga. We've chosen first-line head and neck for several reasons. One, it is a significant addressable patient population. And two, only one in five patients benefit from the standard of care. And even with a 12-month medial mobile survival, there is plenty of room for further improvement population. In addition to that, we see that most of the drug development for first-line head and neck is focused on the HPV-negative patient population, whereas Abisuva is focused on the HPV-positive patient population. But there is further upside for Abisuva. 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. So we do see further significant upside for our basula in the future. At the ECLO conference, we show interim data showing the overall from the 13 patients that were enrolled into the Part 1 trial. Part one was focused at investigating three different doses of Abizuga 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%. So 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 CO2 trial where we investigated apesuva on top of atezolizumab in the advanced cervical cancer setting. So with those two trials now, we do see a strong trend towards an additive effect of apesuva on top of checkpoint inhibitors. At the AACR, both at the ICMA 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 immune therapy with the mechanism of action of Apizuga. You do need to see a strong correlation between the immune response to the antigens And the chemical 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 just chose to show you one slide. This one is probably the strongest slide showing the ability to drive this response in all patients dosed with six or nine milligram. Again, it aligns well with what we saw in the CO2 trial when we tested this in cervical cancer patients. So, it adds to the very, very strong trend we see with Abizuga. This, of course, all this data strengthens our conviction that Ability, a randomized phase two trial, and first line head and neck, is the right next step for FabriZuga. Shown here on this slide is the design of Ability. And as I mentioned, we have moved from the phase of starting up the trial into execution. We are now approved in seven. different EU countries in addition to the approval we received in UK before year end. We saw the first patient dose in May and 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 availability so we can make sure we have the sufficient number of sites engaged to recruit the approximately 100 patients in a timely fashion. Of course, everything is aimed at generating the first interim readout in 2027. With those words, I'll hand over to Auneide to take us through an update on DB10 Neo.

Thank you, Michael. Yes, so in VB-10eo, we have a later 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, importantly, Phase III randomized trials with their individualized neoantigen therapy. So these 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. And we are focusing on a conscious-based strengthening disposition and a few key activities. In this quarter, we have focused on the antigen selection part with our proprietary NeoSelect and also on continuing to improve the supply chain. give you more details on the progress there in the next coming months, including our participation presentation at the 9th International Reaction Summit in July. So you can follow the progress in more detail when we come to this conference. Then some updates on the tolerance program. Over the last year we've seen numerous highlights on on why we want to pursue a 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. They also give you a bit more detail on the modular APT targeted platform and how using different APT targeting units allows the immunotherapy to get into different cell types and process and different efficiency presented to regulatory T cells and then 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 action-specific regulatory T cells but also importantly the next step in the cascade suppression of effective CD4 and CD8 T cells and also an effect on reducing also antibodies importantly. One of the key features that is important for taking this into the clinic and the commercial setting is to be able to have a convenient delivery and also favorable safety profile in addition to have a technology that can be manufactured as a standard biologic. And 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 preclinic to the clinic, as we're seeing now also with our CMC efforts in this program. And today we'll also see a bit more on the human APC translational data that supports that. We do have a path from preclinic to clinic that can 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 iCODES on the back of a technology that's been clinically validated in oncology. So, 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, so 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. And then subsequently these vaccine molecules are taken up by the antigen presenting cells process and epicals presented on MHC molecules to regulatory T cells, which you also see today. We have a set of the system that nicely shows us how effective this is being going through the antigen presenting cells, which we can use in order to identify the optimal human versions of the APC targeting units for clinical use. And then thirdly, these regulatory T cell proliferation, which I'll show you here. So here on this slide, you can see that we have now made human versions of our molecules that bind to human antigen presenting cells. And when we compare that to non-targeted, 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 the relevant cell. And 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 molecule 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 TSOF. It's the same method, so you can see that if the shades are shifted to the right, you will have more and more of these effective antigen presentation on antigen presenting cells. Again, as you can see, the targeted APT targeted therapy is strongly presenting the antigens to regulatory T-cells. on the HLA class II antigen complex that we're measuring here. So it means we are getting closer and closer to have clinically ready drugs. And then 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. And 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 reglycerid T cells. and much better proliferation of these regulatory T cells than the non-targeted version. And then the percentage of those that are truly FOXP3 regulatory T cells differs between the different versions of our technology. So all of these methods gives us much 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 NICODE, 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. Then I think I'll hand over to you, NICO. give us some insights on the AI.

Thank you very much.

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 new therapies at MyCode. 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 DB10 Neo program. So AI and machine learning is a fundamental part of our DB10 Neo program. It helps us select the right Neo engines. In fact, it is one of the core competencies or core assets of our DB10 Neo Select platform, as we have mentioned a couple of times. So 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 my code. So 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 getting further insights into also on the update on VP10neo at the New England conference during summer. So as I said, AI is a fundamental part of our VP10neo program. We've been using that to optimize each and every construct we've developed, using it to train the algorithm and select the right ones, the right targets for each patient. Based on the learnings we generated with NeoSelect, we have also taken that over 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're also using AI across the company, also in the non-research and development related functions, focusing on building up AI literacy across my code. So everybody is using AI frequently. Now we're using it to increase the knowledge sharing across the organization, but also to speed up our work processes and facilitate leading, flow, decision-making, and editing. So we do feel ourselves as a very AI-capable organization. We'll 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'll hand over to Har 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, affecting a reduction in organizations. Financed income and costs were net 2.4 million positive in the quarter, which made a related interest income and unrealized currency movements on Norwegian crown exposure. The reduction in income tax is due to a shift during 2020-05 from a deferred tax liability to deferred tax asset position, which in accordance with IFRS is not recognized in our account. Overall, we recorded 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 when 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. NACODE 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 in 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 later 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 flow number into 2029. Moving on to equity and liabilities, we have total equity of 87.5 million, which represents a strong equity ratio of 93%. And with that, I will give the word back to Michael. Thank you very much.

Just to finish off before we open up for questions with the outlook, reminding everybody we are very well capitalized with Runway. It takes us past a number of very important inflection points. Our focus for the next 12 months is obviously on the execution of Ability, so expanding the number of countries and sites involved in Ability, making sure all investigators are motivated as searching for the patients that we need to be involved in this trial. We also do expect, according to the guidance we have received from our peers, to see key peer readouts from individualized neuroendocrine therapies. In particular, we are looking forward to see the data from the phase three trial of Moderna and melanoma. And of course, we will be looking forward to see continued progress on our autoimmune disease platforms called the ASIC platform. A little bit longer, we're looking forward, we are focusing on being ready for the first interim analysis for Ability in 2027. And we do expect to see a continued string of peer readouts within the individualized neuroengineering therapy as we progress through 2027 and into 2028. So interesting times ahead of NICO.

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 Kyra Holum from D&B Carnegie. How should we think about the level of market communication about the pace of patient recruitment going forward? And 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, Gaius.

So we obviously will, as usual, be using the quarterly webcast here to update on progress for ability. I think that is the level of detail we will be providing. We did announce the first patient in, as is usual, for biotech coming to our house. But don't expect us to keep announcing it 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, but we mainly see the competition in the segment called the HPV-negative patient populations, which is specifically the ones we are not targeting without the silver. uh patient segment looks slightly more favorable for for us and as i said there are countries where we we do see competition the the obvious main competitor for nico right now in terms of patient recruitment is the ongoing trial from biontech also searching for the same patients we are and our understanding is that that trial will be finalizing enrollment in the not-too-distant future. I think we can take the next question.

Certainly. Our next question is a two-part question. I'll ask them in two separate parts. From Georg Tikolanov from ABG Sundell Collier. He says, thank you for taking those 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 authorities, or rather a procedural issue related to processing times within the public system?

Thanks, Georg. Now, our understanding is that this is purely procedural issue due to the caseload they have and also the priorities they have to make according to law. No other reasoning on that.

And the second part of their question is regarding ability, could you please elaborate on the latest planned geographic footprint, specifically how many clinical sites and how many countries are currently targeting in total? And he wishes best regards.

So, again, also, Gero, 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, so that we will need somewhere between 40 to 45, 50 sites to enroll within the two-year timeframe that we've given ourselves. So that's the number we are aiming for, probably going up towards 50. And 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 20% of the sites will be enrolling the 80% of the patients. So if there was a way to find the 20% of sites, of course, that would be easy. But in order to get those 20%, you usually need to shoot a little bit over the target. So that's why we are aiming for probably up towards 50 sites into this trial here. And I see, Kevin, we have received some questions in Norwegian.

I think I will try to read those.

This is a question from Eric Hoffland. First question is, how many patients we expect to have recruited by the end of 2026? And 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. So I assume that'll be slightly into the second half of 2027. And that means recruiting at least one-third of the patient number there. We do intend to enroll up to 100 patients into this trial here. Second question from Eric is how would we rate a clinical meaningful results 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 likability 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 rates, ultimately overall survival. There is the safety questions. There is tolerability. There is immogeneity. And success will mean a good outcome on each of these scores. So 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, but at least if we take the data we have seen in the CO3 trial, if we would be able to replicate something that looks like what we saw in CO3 part one, we would be extremely happy. Combined, as I said, with the good outcome of ORR progression-free survival, a strong immune response correlated with the clinical outcome and a continued favorable safety profile as we saw from the interim CO3 data.

I 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're given, we started out the year with just over 60 million in cash, and we've guided into 2028, so that's roughly 7.5 million per quarter against the a cash flow of roughly 10 million in the first quarter. So, it will fluctuate a bit depending on progress on the trial. If you look at this quarter, we have some prepayments related to startup of the ability trial, roughly $2 million just on that, which is also reflected in the other receivables, which went from 1.6 billion to per year end to 4 million per the end of the quarter, which reflects repayment for services under Ability Trial. So 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.

And last question from Erik. I think that's a question for you, Aredin. When do we think the partnering interest for Abyss Silver will be concrete or solid enough? Is that going to be before or after the ability 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 CO3 is continuing to support partner negotiations Obviously, Ability first randomized data indicating a delta between the Keytruda-only arm and the Keytruda-plus Abisuba will be very important for partners in that respect. So we are having a lot of discussions with partners moving towards that first next big inflection point that we have internally. And as a third aspect for partners is also key data. So everything from all the cancer, including the individualized therapies, whether they are successful or not, has an impact on other pharmacists. They're interested in the cancer vaccine space broadly and not necessarily only for the new program. And then we have a couple of peers. that are also pursuing an HPV16 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 they're differentiated. We can also receive increased interest with negative biotech data and positive biotech data is also supportive for our program with our differentiation. So, multiple potential steps 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.G. Wainwright. I'll ask them in several parts. The first part is, both 6 mg and 9 mg were safely cleared and both delivered 100% HPV16-specific T cell response rates. Given the single transient grade 3 rash DLT at 9 mg and the comparable immunogenicity at 6 mg, What is the rationale for the dose or doses carried into ability? Are you taking 9 mg forward as a single RP2D or running a dose comparison in a randomized portion to de-risk a future label?

So, from all objective parameters that they've looked into the details of both safety, clinical responses, immunogenicity, durability and everything in this CO3 trial, It is obviously 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, and there is a tendency to a higher immunogenicity in the 9mg versus the 6mg, and it's very standard to move forward with the highest dose that is safe for the patient, including also You may have seen at ICNO a patient case, a nine-week patient that has a quite remarkable clinical response. So we are moving forward with the nine-week dose as a single dose, but compared to the chemotherapy.

Very good. Next question.

The next question from Luis Santos at HC 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? And what specific efficacy bar, ORR, PFS, MRD negative, or RFS, would unlock the next clinical step?

Thank you very much for that question, Lewis. And I'd like to think we have been very clear on our strategy with VBT and NEO, reflecting that the capital need to run any clinical trials in the individualized neuroendocrine 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 already described earlier in this call here, as well as making sure we have a locked-in way to go clinical and supply setup. So, in other words, to position ourselves as the most attractive unencumbered individualized neuroendocrine therapy assets out there. ready to leverage any potential positive data coming out of, in particular, as we said, Moderna's ongoing phase three trials within this phase. That means that it is not our plan to take BB10-Neo into a clinical trial on our own right now. Now, what the trial would look like if we found a partner and the partner tried to go into a clinical trial would, of course, be subjective to good discussions with such a partner. We have experience with that kind of discussions from our past partner. So we, of course, will come to such a discussion with strong opinions and insight. And 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 BB10-Neo, in particular, forms into an earlier stage patient population. addressing locally advanced adjuvant setting rather than going into heavily pre-treated, hard-to-treat patients with heavy tumor burdens. But that's just how we see the space of IMT right now. I think we can move to the next question.

Certainly. Our next question from Luis Santos from HCMainRite is, on your AAS IT platform, are BD discussions active? What stage are they at? And what economic structure are you targeting? And if partnering on ASIT is delayed, would you self-fund through FIH or post-progression?

Yeah, thank you, Luis. As you may know, the field is a very interesting field. Autoimmunity has got a lot of focus with pharma these days, and there is a lot of progress on pharma. 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 patient. So we do see a lot of interest from pharma in this program. 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. So 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. And 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 next year.

Thank you. Thank you.

We reach out to 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's always good to meet you at this occasion here. I'm 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 Health Commerce Webcast. Let me just connect your line at this time and have a wonderful day. We thank you for your participation today.