Moderator
Greetings, and welcome to the Nykode Therapeutics Q2 2026 financial results presentation. At this time, all participants are in a listen-only mode.
A question-and-answer session will follow the formal presentation. You may ask a question at any time by typing it into the ask a question feature on your screen.
As a reminder, this conference is being recorded. It is now my pleasure to turn the call over to CEO Michael Engsig.
Please go ahead, sir.
Michael Engsig
Thank you, Kevin. 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 forwards. 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 Hovland, our CFO.
For those not familiar with Nykode, just a few words on the company. Nykode is a clinical-stage immunotherapy company with a focus on oncology and autoimmune diseases.
Our lead asset is avaccuum, 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 2 trial in first-line head and neck, which is ongoing and called Ability.
On track to deliver the first interim results in 2027. Our second clinical asset is VB10.NEO, which is an individualized neoantigen 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 VB10.NEO from more than 10 tumor types, and based on the manufacturing process, which of course centers around plasmid DNA, 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 cost and 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 word to Agnete. It's been another interesting period, starting from the back.
Last week, we saw what 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 but we feel in in general all cancer vaccines, so that means also the off-the-shelf. We'll have Agnete discuss that in more details in a few seconds.
We also showcased our data at the Neoantigen Summit in July from the from the NEO asset, and we'll also have Agnete say a little bit more about that, and she'll go through it. Finally, we also disclosed we have a new patent granted for VB10.NEO, which further solidifies the IP protection around our asset.
Finally, just want to highlight that our Ability trial, the randomized Phase 2 trial with avaccuum in first-line head and neck is progressing as planned, which brings us online for an interim result in 2027. We'll get to say a few words on that a bit later in this call here.
With those words, I'm going to hand over to Agnete to take us through an update on VB10.NEO.
Agnete Fredriksen
Thank you, Michael. You may notice that we start off with uh 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, uh we have been waiting for this moment uh to see what we expect will be the first approval of a cancer vaccine ever. Um 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. 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.
The INT platform uh 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 um method in order to find the relevant neoantigens.
Um It's also important that the manufacturing process is as uh less complex as possible so it can be scaled uh to expand into multiple tumor indications uh at a stage uh that can be competitive, commercially both on turnaround time, and also cost of goods. Um And individualized neoantigen therapy basically uh takes a tumor sample from the patient.
Um You can do that no matter which tumor type. Uh And that means this therapy can be applicable across solid tumors wherever you can find mutations.
Um Importantly now, the the first trial that we've seen being successful now with Merck and Moderna INT trial is in melanoma adjuvant setting, early stage, where you have removed surgically surgically removed the tumor, and then vaccinated uh to delay or prevent recurrence. Uh When you uh 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 uh with whatever other immunotherapies that will be given in that time period for each indication.
First, um, a little reminder on what we saw last week. Uh It's the readout of the Phase 3 INT001 trial, which is the first Phase 3 trial of any cancer vaccine, and in principle a individualized cancer vaccine in patients, as I mentioned, that is in the locally advanced or adjuvant setting.
This first one is in melanoma patients um in adjuvant setting, uh stage IIb to IV. It's more than 1,000 patients enrolled in the trial, and we saw with the very first readout uh 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 distant metastasis-free survival. Uh So, these data seem very impactful.
We expect to see all the data in detail at a conference later, most likely at ESMO. Um Importantly, without seeing the data, they announced that both MSD and Moderna will um jointly pursue regulatory approval on the back of these results, um which means we're most likely looking at the first cancer vaccine being approved for commercial use.
Uh So, this is a big change for the cancer vaccine field. Uh Cancer vaccines are now suddenly derisked as a modality.
Um And now it's about finding the right setting and the right technology that can uh support competitive commercial case across lots of different indications. Um We will see more data coming out now uh 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. Um So, we will see the the breadth of the potential for for cancer vaccine.
Uh Then again, it's for us also important that this not only validates individualized neoantigen therapies, but also off-the-shelf cancer vaccine. For uh individualized, uh there are two uh important points in order to to be competitive and build the best commercial attractive cases 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, uh also those indications where there are few tumor mutations, um and uh immune and technology that can elicit immune responses against a sufficient breadth and quality that can correlate with clinical outcome.
Obviously, also, as I said, safety reactogenicity that permits uh 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 um attractive uh case when it comes to a individualized therapies uh than an off-the-shelf. This is going to be super important here.
VB10.NEO is unencumbered. It's clinically validated, uh individualized neoantigen therapy.
Nykode was one of the first companies, biotech companies, that went into the clinic with individualized neoantigen therapy already in 2018. Um Neoantigen selection platform is something we have used from the beginning as a proprietary, wholly-owned, wholly-developed neoantigen selection platform.
Uh We've also proven that that works. Uh We can have used that to to identify uh neoantigens like in more than 10 different tumor types, um that includes indications with low tumor mutational burden.
We do manufacture and provide this as a plasmid DNA vaccine, which is per definition a manufacturing process with fewer steps, which should be give faster turnaround time and lower cost of goods. Um And we believe that VB10.NEO then will be uh very attractive for this kind of therapy, and capture the broad uh potential of the market.
Going a little bit back to the data uh we've uh had with uh VB10.NEO, um you know our technology, we incorporate the neoantigens in the antigenic unit per patient, and it's linked to our dimerization and targeting unit. Um Compared this as you see to the to the right, we can uh identify a stronger immune response against the set of neoepitopes.
Uh Here shown for the MC38 model. Uh as we have clinical experience uh with um VB10.NEO across two trials, both basket trials, both in late-stage uh cancer patients, uh we have been able to show that our neoepitope selection algorithm that we call NeoSelect, uh systematically prioritizes the most immunogenic neoantigens, or even within the up to 20 neoepitopes that we include in the vaccine.
It is in principle the number one that is the strongest uh immune response, eliciting strongest immune response in the clinic compared to uh number 20. We have not seen that with other uh trials.
To our knowledge, uh we also reported uh a correlation between immune responses against the neoantigens in the vaccine and overall survival. Um To our knowledge, we're the only one that has shown this.
Uh It's uh What's shown here is even in those patients with uh low baseline uh immune response, uh and those then in this group that elicits uh strong immune responses against the neoantigens in the vaccine, also do survive longer. When it comes to the manufacturing process, um we have uh worked uh for multiple years on the manufacturing process uh with uh a set of selected providers that are uh distributed around uh the world.
Uh So, even with this setup um and all experience we gained, uh we have reduced the manufacturing turnaround time from 18 weeks in the beginning to um lower and lower across the clinical um experience. Uh since we uh got the product back, we have uh some key improvements uh that now gives us a current optimized manufacturing process with the setup that we have uh with less than six weeks.
Um That includes um drug substance and drug product manufacturing processes has now been consolidated under one roof, which is important uh for optimized slot utilization and shipment timelines. We have improved DNA isolation methods and optimized DNA plasmid synthesis process.
Uh And this has led us now to a less than six-week manufacturing process time. Uh And then we now we are still working with multiple providers, and that includes shipments, and it includes weekends, et cetera.
Further development of a simply more consolidated in-house process with removal of all these holding steps uh can give us a clear path to four-week manufacturing time. We're already competitive at this stage, and can and should be uh competitive uh with the further um optimization that will be very logical to implement before commercial use.
Um And to support the cost of goods um uh statements, when you look at the number of steps in in manufacturing plasmid DNA compared to mRNA, there are just simply fewer steps in the manufacturing process, um which uh support why we strongly believe um this would lead to a uh a shorter turnaround time and cost of goods uh just by the fact that we do plasmid DNA. Uh we are very happy where where we are, and with the clinical data and the stage of the program.
Um We have still uh we're still an innovative co- company. Uh and we have worked over the last period with further improvements of our um uh APC-targeted technology platform.
Uh and you can see here some some of the data generated over the last year where we are able to uh find improvements that can even further um uh enhance the immune responses uh against also here in the neoantigen context. Uh So, this can be important for even a further competitive edges uh in the future across different indications.
To sum up, uh it has been an emotional week um for Nykode uh when it comes to the uh strong now validation of cancer vaccines uh in general, but also giving us all this confidence back on the individualized neoantigen therapy um and VB10.NEO uh in particular. Um We have uh two completed trials um actually across 13 different tumor types, uh including tumor types with low tumor mutational burden.
Um We have seen between 88 and also in the late latest trial, 100% of the patients uh responding with the immune responses to um our vaccine even in late-stage cancer, and it does have a very clean safety profile, not only safety, but also very low reactogenicity. Uh Interestingly enough, the immune responses that we see also correlate with overall survival from what we can see with these basket trials, uh so, to our knowledge, that is unique to this class.
Not to forget competitive manufacturing turnaround. Uh competitive manufacturing turnaround al- already less than six weeks, 100% uh batch success, simpler manufacturing process compared to mRNA, and uh good timing with the US patent uh now also extending into to a broader protection um potential against the our construct.
Then I hand back to you, Michael. Avaccuum is still super important, although we are [laughter] enthusiastic about VB10.NEO as well.
Michael Engsig
Certainly, Agnete. Thank you very much for for for that review.
Um we'll do keep it short on on avaccuum um this time here. As you all know, our current focus for avaccuum is on first-line head and neck.
Um and head and neck cancer does represent a very sizeable patient population with more than 60,000 uh new cases of HPV16-driven head and neck cancers across the EU and US every year. Um The unmet medical need is still significant for this patient population with only one in uh five patients actually responding to the standard of care, and the median overall survival uh no longer than 12 months for for the standard of care.
Furthermore, um although head and neck does receive a lot of attention right now uh across the field of of uh drug developers, the main bulk of uh drug candidates in development for head and neck are actually focused on the HPV-negative uh population. Um here we are targeting a population that is not well-served or addressed by current drugs in development.
Um Finally, we are looking forward at a uh expected future significant growth in the HPV16 head and neck cancer uh cases uh and a very attractive um projected market increase um for for the next decades. Uh Worthwhile noticing is this is not the the only area for uh potential area for avaccuum.
There is also very um sizeable patient populations, particularly in the cervical cancer, that can be addressed. Um Right now our focus is on first-line, but if we also start looking towards the early-stage uh settings, the locally advanced or the adjuvant, then the the potential increases uh even more.
Um This, of course, is something we will have in mind as we uh plot the uh future for avaccuum um going forward. Most important activity in avaccuum right now is of course our randomized Ability trial, Phase 2 trial uh enrolling up to 100 patients, um and rise and randomizing into two arms.
Um The experimental arm is avaccuum in combination with pembrolizumab, which is the standard of care in this patient population. The other arm, the control arm, is pembrolizumab alone.
We will be uh assessing uh objective response rate and progression-free survival as the co-primary endpoints in this trial. The protocol is now approved in eight European countries, um so seven EU, and uh on top of that, UK.
Um The first patient was enrolled in Poland uh in May 2026, and since then, the patient enrollment have further expanded across additional sites in the UK, Spain, and France. We do see um progress as uh planned uh in this trial.
Focus going forward is, of course, to further expand uh the number of sites and countries. We do expect to um add two to three additional countries to the list, um and uh and ensure that we have full engagement and motivation from our investigators across these uh countries.
All in all, we are still on line, on target for an interim readout in 2027, and will of course keep you updated um further as as we get a better um view on uh when in 2027 we can expect to see these data. We have also uh started looking uh in particular on the back of of the Moderna uh data last uh week.
We feel further encouraged by that. Uh we've started to look into uh exploring avaccuum in a locally advanced setting, and we believe there is a huge potential for avaccuum in that setting also.
More on that later. Just a very few words on tolerance, our um third asset uh and the uh acid platform that uh we feel represents a an entirely new uh approach to treating autoimmune diseases.
Um It relies on the same core technology, targeting of the antigens uh to the antigen-presenting cells, um which is uh also in autoimmune diseases, a key regulator um of the immune response. For our acid platform, we have adapted our technology to restore the immune uh uh tolerance in the autoimmune diseases, um which um we believe is a key to addressing autoimmune diseases um going forward.
Um We are progressing the acid platform um forwards uh towards the first clinical development program, and we will be guiding you more on uh that path in the coming period. With those words, I'll hand over to Harald to take us through the financial results.
Harald Gurvin
Thank you, Michael. Looking at the income statement, other income of 106,000 for the second quarter relates to government grants.
Employee benefit expenses for the quarter were 2.3 million compared to 2.9 million for the same period in 2025, reflecting a reduction in organizations. Other operating expenses were 4.1 million in the second quarter, up from 3.4 million in the same period in 2025, reflecting increased cleaning clinical activities following initiation of the Ability trial.
Finance income and costs were net uh 400,000 negative in the quarter, which mainly relates to interest income and unrealized currency movements on Norwegian krone exposure. Overall, we recorded a net loss of 7.2 million for the second quarter, compared to net profit of 800,000 for the same period in 2025.
Moving on to the balance sheet, we are still well-capitalized with a cash position of 44.8 million at the end of the second quarter. With discipline in 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 33.4 million at the end of the second 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.
The latest we have from the secretariat in the Tax Appeals Board is that we can still expect to receive a draft recommendation from the secretariat in August. We expect to communicate to the market immediately once the draft recommendation is received and we've had time to process the information.
A positive outcome will push the cash runway into 2029. Moving on to equity and liabilities, we had total equity of 80 million, uh which represents a strong equity ratio of 93%.
With that, I will give the word back to Michael.
Michael Engsig
Thank you very much. We'll just uh conclude with the outlook before we open up for questions.
As stated earlier, um well-capitalized uh with a runway uh into '28, and uh as was said, uh this will further extend with a possible outcome on the pending uh tax case. Um That brings us uh well past uh a number of of significant inflection points for for our assets.
Focus for the coming period will, as uh said before, obviously be on the execution of the Ability uh trial, where the uh the priorities right now is to expand the number of countries and sites, get the sites engaged, motivate the investigators to identify the patients. Currently on plan for an interim uh readout in 2027.
In addition to that, we see a number of uh potentially very exciting uh data reading out from peers uh across the cancer field, uh similar to what we saw last week. We will, of course, be uh keeping a keen eye on uh on our uh most important peers in the field for for the coming period.
As Agnete says, uh this field has never been more exciting than than what we're seeing right now for for cancer vaccines. We are expecting, based on guidance from the authorities, um a first a draft recommendation on the tax case in uh in August, um and uh we will uh continue to um progress and mature the acid platform, uh bringing us forward towards the first clinical development program.
Um And uh that continues into 2027, where we do we do expect to see further uh peer data uh from from our peers reading out, um as as well, of course, the the uh being able to report the Ability interim results during 2027. Exciting periods ahead of us.
Um and with those words, I think we are ready to conclude the uh formal part of this call, and move to the questions. Kevin?
Moderator
Thank you. We will now be conducting a question-and-answer session.
If you'd like to ask a question today, please type the question into the ask a question feature on your screen. Our first question today is coming from Geir Holom from DNB Carnegie.
You state that the Ability Phase 2 trial is uh progressing according to plan, and reiterate that the first interim efficacy readout is expected in 2027. Could you elaborate on the key parameters and milestones you're monitoring to assess the likelihood of being able to present interim data by year-end 2027?
Michael Engsig
Yes. Sure.
Thanks for for the question, uh Geir. Um it it it's getting a little bit technical here, but but um just to give you a feeling for for the kind of KPIs that we are measuring here um and and reviewing against a plan is is obviously um getting the protocol approved in countries um and getting the sites up and running.
Once we have approval in a country, uh the next task for a site is to get uh the site contract, clinical trial agreements uh signed and get the site staff trained uh on all the parameters that needs to be trained, um before we can give uh every site a so-called green light, and at that time point, they can start enrolling patients. We have uh projections both for um countries getting approved and sites getting approved.
That's the most important parameter in the beginning of of the uh trial. Then from there, of course, we begin to uh monitor the number of patients entering screening before they uh subseq- subsequently, and subject to a successful screening, enters the enrolled stage.
That is where they get the first dose. It it's a multitude of different KPIs that we are monitoring uh and reviewing up against a predefined um plan together with the board to be able to to gain confidence that we are on track towards 2027.
I think that's enough said on that question, Kevin.
Moderator
Thank you. Our next question is a follow-up from Geir Holom from DNB Carnegie.
Could you elaborate on the potential paths you're considering to bring your first tolerance asset into clinical development, including the key steps and milestones required to reach the clinic?
Agnete Fredriksen
Sure. Um So, it's a pretty standard uh path uh to the clinic from where we are today.
Uh So, we have worked on the platform and uh made sure we we can uh be confident on the modality and the targeting units, et cetera. From thereon, when we are selected selecting the indications, that that dictates the antigenic uh part of our molecule.
Uh So, then we move on to what we call lead selection, which is when we nail down the exact construct and the the product that we want to pursue into the clinic. Um And from thereon, we both need to do what's called non-clinical tox.
Uh So, there is a tox program you need to make sure that the exact product uh manufactured uh under uh similar uh manufacturing process as you will do for the clinical trial um is safe, uh and considered to be safe to be given to to patients. Uh And as part of that, you need to move that manufacturing process onto also in an GMP-manufactured product.
Um And then all the documentation of this goes into a regulatory filing uh to the authorities, uh together with the then designed clinical development uh plan uh for the first trial. Uh And when we get that approval, we're basically back to what Michael just explained uh from from getting the approval in in each country and setting up the sites, et cetera.
Mhm. Um Part of this, depending on which indications, uh will um uh decide whether we do this uh studies for the first part uh in-house or with a commercial partner or an academic partner, or any partner.
Thank you. Next question.
Moderator
Our next question is coming from Casper Vieren from Arctic. mRNA vaccines are believed to have more efficient delivery as the mRNA only needs to reach the cytoplasm, whereas plasmid DNA has to cross both the cell membrane and the nuclear membrane before expression can occur.
However, your vaccines encode protein that targets antigen-presenting cells, APCs. Would you say you can compensate for less efficient DNA delivery through biological targeting after expression?
Yes,
Agnete Fredriksen
this is a long [laughter] I can talk about for a long time. Uh mRNA and DNA are both genetically based, but they do have very different mechanisms of action in principle.
Uh So, DNA is basically uh the template for making the mRNA. If you inject the DNA, um the DNA will make mRNA.
Um So, there is a huge difference. You can either give the mRNA directly, it's a a product that only needs to reach the cytoplasm, that's true.
Uh But if you don't have the DNA, the mRNA you inject will be the mRNA that you can rely on. There will no not be a new DNA that can encode the m- uh multiple new mRNAs.
Meaning when you give the mRNA, you give it, it reaches the cytoplasm, uh and when that is degraded, there is no new uh genetically encoding uh new vaccine proteins. Which means there is a very different kinetics.
DNA uh needs to go uh into the nucleus, uh but it will then start to make mRNA, and can do that over a longer period of time than giving the mRNA as the only product. Um Then obviously, the protein that we're encoding, um maybe one point first.
The dose that we give of DNA is higher than what you give of RNA, so that also um tells you something. That is also based on the safety process, because both RNA and LNPs as they formulate is more reactogenic uh than DNA.
We can give a higher dose of the DNA than you can of RNA. Then the protein that is being encoded, whether it uh first starts with the DNA, goes through the mRNA, and then encode the protein, or you give it as mRNA yourself, uh needs to be taken up, uh processed, and pre- uh by antigen-presenting cells, processed and presented on um the surface of these antigen-presenting cells to T cells.
Uh And that's where the um our technology with the three components we have in our protein makes that part more efficacious as to how we elicit the immune response. Um So, they all have different methods in order to achieve the end goal, and the end goal is to elicit uh optimal T cell response.
Um So, there are lots of things coming into consideration here. Uh I think importantly for us, DNA, manufacturing costs, um durability of expressing new proteins, and also the um our technology and the way we elicit the T cell responses um is of importance.
Cost.
Moderator
Thank you.
Agnete Fredriksen
We can go to the next.
Moderator
Yep. Our next question is a follow-up from Casper Vieren from Arctic.
Your current time for VB10.NEO uh from biopsy to injecting the vaccine in a patient is approximately six weeks. How fast can you compress it to four weeks, and what needs to happen to achieve this?
Agnete Fredriksen
Thank you very much, Casper. Also a a good question.
Um So, importantly, the optimizations we have uh seen so far, and the optimizations we are looking forward at is basically optimizing the current process that we have. We are looking at refinement and adjustments of of our supply setup uh by combining things under one roof, and um further um optimizing the the logistics.
The um improvement from uh our current level at around six weeks, or just below six weeks, towards four weeks is more of the same. Um So so that would uh mainly see uh further investments.
It would see uh more intensive shifts, um things like uh weekend work to basically avoid the hold times that occurs when you shift between the different stages of of the production. It's more it's more a matter of of actually investing into the process and and see uh more intensive uh labor processes than uh inventing new steps.
Um So, this this can be done in a in a pretty effective way um should the uh should the investments be be warranted. Um So so we're quite confident that would be um a a quite easy fix.
Next question?
Moderator
Thank you. Our next question today is coming from George Tingbø from ABG Sundal Collier.
George says, "Good morning, and thank you for taking my questions. I have two.
In the report, you state that Ability continues to progress according to plan, with enrollment having expanded across additional sites in the UK, Spain, and France. Can you provide some detail on the radio I'm sorry, ratio between screening and full enrollment that you have seen so far?
Secondly, can you provide any color on the extent to which you have already seen a meaningful increase in partner interest or discussions following last week's news on intusertide autogene from Moderna and Merck? Thank you."
Michael Engsig
Yes. Thanks Thanks, um Georg, for for these questions.
I'll take the first question, and then hand over to Agnete for for the second question. Um On the first uh question, it is too early to to conclude on any meaningful uh trends.
These countries do have um so some of the processes that are necessary for setting up the sites are a little bit unique to the country, we do see the countries coming online, if you can so call so, uh with activation of the sites a little bit in waves. Therefore, any trends that you see right now would not be be meaningful to conclude anything um on.
It's it's too early to to say anything. Um So far, we're we are happy with the um both the activation of sites across the uh countries and the engagement we see from from uh investigators.
Also, we've not seen anything concerning in terms of screening failures. Um so uh as I said, and I'm repeating myself here, uh to to to date, we are quite happy with uh with the start of progress of of the Ability um trial, and it has also been uh the full focus of the organization, so as I said before, this is prior- priority number one, two, and three, and it's has all hands on deck for for this trial here um in in the team, um very happy with what we're seeing so far.
I'll hand over to Agnete for for the second part of this question here.
Agnete Fredriksen
Yeah. Um And thank you, Georg.
Uh we can't comment on details on uh on uh what's happening uh directly with the dialogue with potential partners, of course. Uh What I can say is that we should I would be surprised if would be surprised if uh the partner interest in cancer vaccines, including individualized cancer vaccines, uh would not increase on the back of these news.
Um Importantly, I think you should know that this comes on the back of the first ever trial of any cancer vaccine tested in a Phase 3 setting in adjuvant, in the adjuvant setting, where you have removed uh the the bulk of the tumor, and then you vaccinate, and you prevent recurrence. It does not come on the back of other technologies failing, or it does not and it does not come on the back of other cancer vaccines um failing in other uh cancer indications in the adjuvant setting.
That should, in my mind, lead to a lot of curiosity for pharma partners uh as to explore the potential of uh additional cancer vaccines, both off-the-shelf and individualized, in a range of other indications, and and see which ones is the best. Um as these others have just simply not been tested yet uh in that setting.
Um And then, we've seen this happen before with the GLPs, and with antibodies, with checkpoint inhibitors, et cetera. On the back of the first success, uh usually uh there is an uh increased uh change in the strategy of on multiple uh comp- pharma companies wanting to be part of the the new wave of a new uh modality.
Moderator
Thank you. Next question.
Certainly. Our next question is coming from Eirik Hafskjold from Eirik Investments AS.
You have previously shown that NeoSelect's ranking correlates with actual immunogenicity in patients. How do you feel feed clinical data back into NeoSelect to improve future vaccine designs?
Does this mean that NeoSelect could potentially become better as you accumulate clinical data for more patients in vaccine designs?
Agnete Fredriksen
Yes, this is both a technical question and a regulatory question, um or an answer, at least, to your question. Uh So, yes, uh everything we learn uh currently, uh we assess whether that can uh be used in order to further improve uh NeoSelect.
Um So, we take that very seriously, and and we're the amount of clinical data and the established high-quality uh competence that we have um gene- uh have in this company, uh is something uh that I feel is a competitive edge. Um And then, um as we know, part of a clinical development program within certain indications, et cetera, uh at a certain time point, you need to lock down uh the neoantigen selection methods.
Um So, that we will also, obviously, keep in mind, and do that uh at the right time point. Next question.
Moderator
Thank you. Our next question is a follow-up from Eirik Hafskjold from Eirik Investments AS.
Following the positive Phase 3 results from Merck and Moderna, what do you now see as the key characteristics that differentiate VB10.NEO from other individualized neoantigen vaccines?
Agnete Fredriksen
That's a long list that I went through in the in the webcast. Uh So, we do think there are multiple uh multiple features that are key differentiators.
If I were to select one um from now on, I do think the uh less complex manufacturing is uh going to be extremely important, um as uh we don't see so far that the immunogenicity data uh generated by the quite limited uh clinical re- um uh reports from Moderna is not um it's not scary for us, uh but we also don't know at this stage what the immune responses uh are needed, and across different indications. The manufacturing process is the key, and then it's all the uh technology's um abilities to be applied in additional uh indications and provide efficacy in those as well, in addition to what we've now seen in in melanoma adjuvant setting, um will be uh interesting.
Moderator
Thank you. Our next Next question.
Certainly. Our next question is coming from Eirik Hafskjold from Eirik Investments AS.
The Regeneron agreement already demonstrated in 2021 the value of combining large amounts of patient data and antigen selection with Nykode's platform. How important do you believe data and machine learning will be as a competitive advantage for Nykode over the next five years?
Agnete Fredriksen
I think we have just uh seen uh an increasing um a applicability of AI and ML in the last few years. Um The longer we've been around as a company, and the more data we generate, both preclinically and clinically, and obviously, the entire field of AI and ML uh from also the outside of the world, um when you combine all of those, um there is quite impactful uh improvements uh that we can take advantage of on the drug design.
Importantly, I think since we started with individualized neoantigen therapies very early, we have built that experience earlier than most other companies, and we have also now generated clinical data, but also, importantly, preclinical data with our construct with a very high number, I wouldn't say the number, uh of constructs. Uh can use all this data in order to learn um what would be the optimal cancer vaccine design, and also obviously, intolerance.
Um So, for future potential um of additional cancer vaccines, and obviously, for the individualized um and the tolerance program, we will make sure to to take advantage of what we built.
Moderator
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 or closing comments.
Michael Engsig
Thank you very much, Kevin. Thank you very much to everyone uh dialing in to to this uh results presentation and for your uh engaged questions.
We feel you are as enthusiastic as we are for the uh coming period for for cancer vaccines. Uh And look forward to keep you updated on our future efforts and achievements.
With those words, wish you all a good day. Um And um talk to you soon.
Moderator
Thank you. That does conclude today's webcast.
You may disconnect your line at this time, and have a wonderful day. We thank you for your participation today.
Already premium?