Nykode Therapeutics As

Greetings, and welcome to the NICO Therapeutics Q2 2026 financial results presentation. At this time, all participants are in listen-only mode. A question and answer session will follow the formal presentation. You may ask a question at any time by typing it into the ask a question feature on your screen. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to CEO Michael Engsig. Please go ahead, sir.

Thank you very much, Kevin, and also from our side, a very warm welcome and good morning to all participants on this quarterly results presentation. We assume you are familiar with our forward-looking statements and on that note, we'll move forward. As usual, I am very pleased to have with me here today Agnete Fredriksen, our co-founder, chief scientific officer and head of business development, as well as Harald Gurvin, our CFO. For those not familiar with Nycode, just a few words on the company. Nycode is a clinical stage immunotherapy company with a focus on oncology and autoimmune diseases. Our lead asset is Avesuva, a therapeutic cancer vaccine targeted against HPV16 driven cancer types. We have encouraging results across three different indications, three trials with close to 100 patients in total, which gave us the confidence to move into the first randomized phase two trial in first-line head and neck, which is ongoing in cold ability. On track to deliver the first interim results in 2027. Our second clinical asset is VB10neo. which is an individualized neoandrogen therapy. We saw some very important validating results from the field last week and we'll of course be discussing that more in depth at this call here. We have clinical data from VB10neo from more than 10 tumor types and based on the manufacturing process which focuses around pDNA as the rest of our technology, we do feel that we have a much simpler manufacturing process which compared to the mRNA will support a competitive coxin turnaround time at commercial stage. Furthermore, we have over the years developed an AI-driven target selection, which we also believe strongly will add to the competitive edge of VB10 Neo. The strategy for VB10 Neo has been to position ourselves as the most attractive unencumbered asset or INT asset in the area to leverage the type of validating data that we saw last week. Third asset is our tolerance platform, which is right now focused on autoimmune diseases, utilizing the same technology as we use in the cancer vaccines, currently in preclinical stage. We're strongly capitalized with a runway into 2028, which can be extended to 2029, pending the outcome of the tax case. Very briefly on the highlights before I hand over the work to Agnete. It's been another interesting period starting from the back. Last week we saw what we consider probably the most important cancer vaccine data ever when Moderna came out with positive phase 3 data for their individualized neoantigen cancer vaccine. which clinically validated not only individualized cancer vaccines but we feel in in general all cancer vaccines so that means also the office shelf. We'll have Arne to discuss that in more details in a few seconds. We also showcased our data at the neo-engineering summit in July from the neo assets and we will also have a little bit more about that which goes through it. Finally, we also disclose we have a new patent granted for BPC Neo which further solidifies the IP protection around our asset. Finally, I just want to highlight that our Ability Trial, the randomized Phase 2 trial with Abasuba in first-line head and neck, is progressing at plans, which brings us online for an interim result in 2027. I'll just say a few words on that a little bit later in this call here. With those words, I'm going to hand over to Agnete to take us through an update on VP10 Neo.

Thank you, Michael. And you may notice that we start off with NEO today on the back of the very exciting news from Moderna and Merck last year. For those of us that worked in cancer vaccines for decades, we have been waiting for this moment to see what we expect will be the first approval of a cancer vaccine ever. So first I'm going to just remind you a little bit of individualized neoantigen therapy as a class. It's a personalized cancer vaccine targeting specific mutations found in the tumor of the patient. So we identify these by sequencing the tumor and compare to healthy tissue from the same patient and identify these neoantigens, which are tumor-specific mutations, can also be fully patient-specific. So the INT platform means it is fully personalized per patient. That also means you need to manufacture one vaccine per patient, which makes the algorithm-driven neoantigen selection part very important and that you have a A validated method in order to find the relevant new antigens. It's also important that the manufacturing process is as less complex as possible so it can be scaled to expand into multiple tumor indications at a stage that can be competitive commercially both on turnaround time and also cost of goods. As individualized niacin therapy basically takes a tumor sample from the patient. You can do that no matter which tumor type. And that means this therapy can be applicable across poly tumors wherever you can find mutations. Importantly now, the first trial that we've seen being successful now with Merck and Moderna Interpath trial is in melanoma adjuvant setting early stage where you have removed, surgically removed the tumor and then vaccinated to delay or prevent recurrence of When you treat patients at this early stage, there is obviously a high patient number, but it's also important that the treatment can combine, can have a nice safety profile and combine effectively with whatever other immunotherapies that will be given in that time period for each indication. First, a little reminder on what we saw last week. Readout of the phase three in the PASS-001 trial, which is the first phase three trial of any cancer vaccine, in principle, individualized cancer vaccine in patients, as I mentioned, that is in the locally advanced or adjuvant setting. This first one is in melanoma patients in adjuvant setting stage 2b to 4. It's more than 1000 patients enrolled in the trial and we saw with the very first readout that they already met the primary endpoint which is the recurrence free survival. They also already announced that they met one of the key secondary endpoints which are distance metastasis free survival. So these data seem very impactful. We expect to see all the data in detail at the conference later, most likely at ESMO. Importantly, without seeing the data, they announced that both MSD and Moderna will jointly pursue regulatory approval on the back of these results, which means we are most likely looking at the first cancer vaccine being approved for commercial use. So this is a big change for the cancer vaccine field. Cancer vaccines are now suddenly de-risked as a modality. And now it's about finding the right setting and the right technology that can support competitive commercial case across lots of different indications. We will see more data coming out now in the future both in early stage locally advanced adjuvant setting also some data will read out in the future in the first line setting. So we will see the breadth of the potential for cancer vaccines. Then again it's for us also important that this not only validates individualized neoantigen therapies but also off-the-shelf cancer vaccines. or Individualized. There are two important points in order to be competitive and build the best commercial attractive case in as many indications as possible. One of them comes from the technology. It's really important that you have this target selection that can work across indications. Also those indications where there are a few tumor mutations and immune and technology that can elicit immune responses against the sufficient breath and quality that can correlate with clinical outcomes. And obviously also, as I said, safety, reactogenicity that permits the combinations with a range of standard of care. Another very important part here is economics per patient manufacturing turnaround time, and Cost of Goods will have a much bigger role of the attractive case when it comes to an individualized therapy than an off-the-shelf. So this is going to be super important here. Vibetanil is unencumbered. It's clinically validated individualized neon-sense therapy. was one of the first companies that went into the clinic with individualized neoantigen therapy already in 2018. Neoantigen selection platform is something we have used from the beginning as a proprietary, wholly owned, wholly developed neoantigen selection platform. We've also proven that that works. We can use that to identify neoantigens in more than 10 different tumor types. That includes indications with low tumor mutational burden. We do manufacture, provided that they plasma DNA vaccine, which is, per definition, a manufacturing process with fewer steps, which should give faster turnaround time and lower cost of goods. And we believe that BB10 Neo then will be very attractive for this kind of therapy and capture the broad potential of the market. So going a little bit back to the data we have with VB10-Neo. You know our technology, we incorporate the neoantigens in the antigenic unit per patient, and it's linked to our dimerization and targeting unit. Compare this, as you see up to the right, we can identify a stronger immune response against the set of neoepitopes here shown for the MC38 model. and we have clinical experience with VB10 Neo across two trials, both basket trials, both in late stage cancer patients. We have been able to show that our new epitopes selection algorithm that we call NeoSelect systematically prioritizes the most immunogenic new antigens or even within the, of the 20 new epitopes that we include in the vaccine. It is in principle the number one that is eliciting the strongest immune response in the clinic compared to number 20. We have not seen that with other trials. To our knowledge, we also reported a correlation between immune responses against the new antigens in the vaccine and overall survival. To our knowledge, we're the only one that has shown this. What's shown here is even in those patients with the low baseline immune response, and those then in this group that elicits strong immune responses, again, the antigen in the vaccine also do survive longer. When it comes to the manufacturing process, we have worked for multiple years on the manufacturing process with a set of selected providers that are distributed around the world. So even with this setup and all the experience we gained, we have reduced the manufacturing turnaround time from 18 weeks in the beginning to lower and lower across the clinical Experience and since we got the product back we have some key improvements that now gives us a current optimized manufacturing process with the setup that we have with less than six weeks that includes drug substance and drug product manufacturing processes has now been consolidated under one roof which is important for Optimized Slot Utilization and Shipment Timelines. We have Include DNA Isolation Methods and Optimized DNA Plasmid Synthesis Process. And this has led us now to a less than six-week manufacturing process time. And then we know we are still working with multiple providers, and that includes shipments, and it includes weekends, et cetera. So further development of a simple, more consolidated in-house process with removal of all these holding steps can give us a clear path to four-week manufacturing time. So we're already competitive at this stage and should be competitive with the further optimization that will be very logical to implement before commercial use. And to support the cost of goods statements, when you look at the number of steps in manufacturing plasma DNA compared to mRNA, there are just simply We are very happy with where we are and with the clinical data and the stage of the program We are still an innovative company and we have worked over the last period with further improvements of our IPC targeted technology platform. And you can see here some of the data generated over the last year where we are able to find improvements that can even further enhance the immune responses against also here in the neoantigen context. So these can be important for even further competitive edges in the future across different indications. So to sum up, it has been an emotional week for my code when it comes to the A strong now validation of cancer vaccines in general, but also giving us all this confidence back on the individualized new antigen therapy and VB10 Neo in particular. We have two completed trials, actually across certain different tumor types, including tumor types with low tumor mutational burden. We have seen between 88 and also in the latest trials, 100% of the patients responding with immune responses to our vaccine, even in late stage cancer. And it does have a very clean safety profile, not only safety, but also very low reactogenicity. Interestingly enough, the immune responses that we see also correlate with overall survival from what we can see with these basket trials. So to our knowledge, that is unique to this class. And not to forget competitive manufacturing turnaround. Competitive manufacturing turnaround already less than six weeks, 100% batch success, simpler manufacturing process compared to mRNA, and good timing. The US patent now also extending into a broader protection potential against our construct. Then I hand back to you, Michael. Obviously, you are still super important, although we are enthusiastic about Phoebe Thuneo as well.