Greetings and welcome to the Nykode Therapeutics Second Quarter 2025 Strategy Update and Results Webcast. At this time, all participants are in a listen-only mode. A question and answer session will follow a 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, Michael.
Thank you very much, Kevin, and also from my side, a very warm welcome to everybody to this Q2 webcast and not least our long-anticipated strategy update from Nykode Therapeutics. Before moving on, I just want to remind every one of you of our forward-looking statements. We assume you are familiar with those, and on that basis, I'll quickly move on. As usual, I am very pleased to have with me here today Agnete Fredriksen, our Co-Founder and CSO, and Harald Gurvin, our CFO. Before moving into the strategy update, which I believe you've all been waiting for at this time point here, we'll just very quickly or briefly review the key highlights from our Q2 report, which was also announced or issued this morning here. Because we are focusing most of this call today on the strategy, we'll be reviewing the Q2 a little bit briefer than usual.
Still, we did have a couple of very important events during the quarter from the VB10.NEO program. We did announce the key data from our VB-NO-2 trial at ASCO in 2025 in Chicago. These data, once again, highlight our VB10.NEO program's ability to induce robust and durable immune responses across multiple tumor types in a heavily pretreated patient population. Just to remind you here that the number of biotech companies that do have an established manufacturing platform, an AI-driven epitope selection algorithm, and actually clinical data to boost is very small. We'll be reviewing more on that one later today. For our VB1016 program, we are conducting the part one of the VB-C-03 trial, which is in essence a dose escalation program. We have enrolled all the patients there, so 13 patients spread along three different dose levels.
One patient in three milligrams, six patients in six milligrams, and six patients in nine milligram doses. During the quarter, the so-called trial safety group did what we call a safety clear all of the doses for that program, which again underlines VB10.16's very favorable safety profile. Nykode Therapeutics has entered discussions with Regeneron regarding the future of the collaboration programs, and these programs are no longer included in Nykode Therapeutics' updated strategy or our financial forecasts. Finally, from my side, Susanne Stuffers was also elected as Chair of the Board at the extraordinary General Assembly on the 23rd of April this year. I'm going to hand over to Harald for a quick review of the Q2 financials.
Thank you, Michael. Looking at the key financials for the second quarter, total revenue and other income came in at $200,000 compared to $600,000 in the second quarter of 2024, which was driven by less revenue from Genentech and Regeneron. Total operating expenses reduced from $12.4 million in the second quarter of 2024 to $600,000, reflecting the reduced organization following the organizational streamlining finalized in the first quarter of 2025 with full effect expected in the third quarter, and also reduced clinical activities. We recorded a net profit of $900,000 in the second quarter of 2025 compared to a net loss of $7.3 million in the second quarter of 2024, mainly due to reduced operating expenses and also unrealized currency gains relating to our cash held in Norwegian kroner and the non-current receivable relating to the tax gains denominated in the same.
A cash dividend of NOK 1 per share was approved at the Annual General Meeting held on 26th of May 2025, and the dividend totaling $32.3 million was paid on 12th of June. We are still well capitalized with a cash position of $70 million at the end of the second quarter. With that, I will give the word back to Michael, who will take us through the updated strategy.
Thank you very much, Harald. That concludes the Q2 part of this webcast. We'll then move into the updated strategy part, which is no secret. We've been really looking forward to taking you through these thinkings here. It's no secret also that it has been a tough last 12 months for the Nykode Therapeutics company and the team. On the one hand, we were left with great technology, good data, and a strong cash position. On the other hand, we had a disconnect between plans, inflection points, and our cash runway. The first thing we did in that light was to bring down or bring control of our cash burn through a series of significant restructurings and prioritization efforts. This was a very painful but necessary process, and I cannot emphasize enough how grateful I am to the employees and all the shareholders who stuck with us through those times.
Secondly, and in particular since April, since the April events, we have, together with the new board, carefully assessed the strategy and the options in front of us. As I mentioned before, the management team is really looking forward to take you through what we think is a very exciting new strategy for the company. We looked at how we could most optimally deploy our capital on our pipeline to achieve meaningful data inflection points within our cash runway while building as much value for patients and shareholders as possible. That plan, which we will present today, includes a robust phase II randomized controlled trial for VB10.16 verified head and neck, which is expected to lead to significant data within our cash runway. Furthermore, we have also, we think, compelling strategies for VP10.NEO and VP10 or our tolerance program. We'll just quickly take you through the key highlights here.
No surprise for you that we do consider VB10.16 our lead asset with the potential to deliver meaningful clinical data within 24 months. We have very strong confidence in this program supported by data from two completed and one ongoing clinical trial. Therefore, the key activity for us is to initiate a phase II randomized clinical trial aimed at demonstrating proof of concept in first-line head and neck cancer. VP10.NEO is our individualized neoantigen therapy, and that field or the concept of INTs are looking at very exciting peer readouts over the next 18 months, which we think can increase the conviction in the concept of individualized neoantigen therapies. Our job, meanwhile, is to strengthen our position as the most attractive unencumbered INT asset through a selected range of activities, which we'll review with you in a minute.
Tolerance platform, the concept of tolerance induction could transform autoimmune disease treatment in the future. We continue to see data generated in our laboratories, which supports the versatility of our platform and the differentiated perspective. We will continue to invest in really pursuing a best-in-class tolerance induction platform with our technology. All this we'll be doing while keeping a very diligent cost discipline, which on the top of our well-capitalized position allows us to reach key inflection points within our cash runway. We have streamlined our cost base through a series of restructuring and prioritization efforts. The current plan that we have in front of us does not foresee any significant growth in the organization or in the underlying cost base. We'll do a bit of double-click on each of the programs to take you through the rationale and the plans before we open up for questions in the end.
VB10.16 does represent our lead asset, as we said, and that is based on the number of clinical data that we have previously reported from the two trials, CO-1 and CO-2, which if we just highlight the key conclusions from that, did show that our objective response rate in the PL-1 positive patient populations of patients, pretreated patients with advanced cervical cancer, came out double what you would see with the historical trials for checkpoint inhibitor monotherapy. We saw more or less the same effect on median overall survival, so a doubling of what you typically see with checkpoint inhibitor monotherapies from historical trials. We have also with VB10.16 shown a monotherapy effect in the premalignant setting in the CO-1. What we consider extremely important, we have shown that the clinical effects we observe in both the CO-1 and CO-2 are associated with an antigen-specific immune response.
We do consider that a very important part of any cancer vaccine's combined or collected clinical data setting. In addition to the data we have published, we have obviously also been looking into the ongoing CO-3 trial. I remind you all, this is a very limited number of patients, but the preliminary data that we see from the CO-3 does support our investment into this program in the first-line head and neck setting. Based on our conclusion that this is our lead asset where we'll be able to drive the majority of shareholder value in the near term, our next step was to design a randomized phase II trial, which will show VB10.16's contribution on top of the current standard of care, which in this case is Keytruda monotherapy in a head-to-head comparison, which will have the ability to generate clinical data within the next 24 months.
We chose the indication first-line head and neck based on both the unmet need in this market, the combined market potential, and of course also again with the ability to have readouts within our cash runway. In addition to generating very important proof of principle or proof of concept data within the program, we also do believe that this activity will be de-risking the entire Nykode Therapeutics platform as randomized clinical data will have a validating spillover effect on all other APC-targeted cancer vaccines we may deliver in the future, including VP10.NEO. As a very natural step for the development stage, which VB10.16 is, we have also now had approval or acceptance for our INN name for VB10.16, which is abipapogene suvaplasmid or short for abi-suva. Henceforward, we will be calling VB10.16 abi-suva in our continued communication.
First-line head and neck or head and neck in total does represent a significant market potential for abi-suva. The total estimated market size for HPV16-driven cancer types in head and neck is estimated to be $1.1 billion with a predicted CAGR of 9.2%. Patients, the HPV16-driven head and neck patients are younger than the rest of head and neck patients, and therefore does call for more unmet need and stronger investments into this segment. We do see a remaining unmet need since the current standard of care does leave room for improvement, and the majority of other head and neck-focused development programs seem to be focusing mainly on HPV-negative patient populations.
When we look at the direct competitors in the HPV16-specific treatments, we do find strength in comparing our data to what has been reported to our competitors, which again gives us conviction that abi-suva has a role to play in this segment here. Quick look at the trial, which we will be calling Ability. It is going to be a randomized controlled trial enrolling up to 100 patients, randomized one-to-one into two arms. One arm will combine abi-suva with pembrolizumab, the other one will be giving pembrolizumab alone. We will, of course, be enrolling HPV16-positive head and neck patients, first-line PD-L1 positive, and we will be analyzing the usual battery of endpoints with ORR and PFS, and of course also median survival as some of the key ones to look at for this trial here.
We will be planning a series of interim analyses, and very importantly, the first interim analysis, which will encompass approximately one-third of the patients, is expected during 2027, which is within our estimated cash runway. In summary, we consider abi-suva our key asset and key value driver. We do see a large remaining unmet need, which needs to be addressed. We have high conviction in our program based on two finalized and one ongoing trial showing strong and durable efficacy correlated with immune response, a very favorable safety profile. We've shown this both in advanced cancer and in premalignant setting. In addition to the two finalized trials, the preliminary data from the ongoing trial also does indicate support and does indicate the same level of benefit on top of the standard of care, which gives us the conviction to move forward with this plan here.
Our strategic approach is to start a randomized controlled trial and is designed both to show effect on top of standard of care and to deliver the first interim analysis well within our cash runway. I'm going to hand over the mic to Agnete, who will take us through the program for VB10.NEO.
Thank you, Michael. There is no doubt that we are entering a defining period for individualized neoantigen therapies. We know that this space has a huge market potential. It's possible to treat basically all tumor types with an individualized neoantigen therapy. These days, we are actually looking at ongoing phase II and phase III randomized controlled trials using this concept from our peers. There's a strong focus these days on doing these trials in the adjuvant setting, meaning in patients that have gone through a definitive treatment where the tumor mass is low and where these therapies are now actively being pursued. We've never seen higher investments in the space before than what we see now. These key readouts from these peers are expected within the next 18 months, which we consider shortly. It's an emerging space.
We see a huge potential market, and there are currently, as Michael alluded to, a few players that are in position to move into this market. There is also definitely room for technologies with improved efficacy, also with improved cost of goods and turnaround time, which is essential for succeeding with individualized therapies. We do believe Nykode Therapeutics is now well positioned as the most attractive unencumbered individualized neoantigen therapy. We intend to further strengthen this position as the most attractive unencumbered INT through selected activities, ready then to leverage peer readouts. Going through some of the key data points that we feel are putting us in a good space in this field, we have our own in-house proprietary AI-driven epitope selection algorithm able to select individualized neoantigens from each patient based on their biopsies and identification of tumor-specific mutations.
We have even seen that within the 20 neoantigens that we select per patient, our algorithm is ranking the top 10 higher than the top 20 of the 10 to 20 neoepitopes. There is even a correlation between the epitopes that we select to be predicted to be highly immunogenic and those that are actually proven to be immunogenic in our patients so far. In general, we can say that we have seen strong immune responses in our clinical trials. We have clinical data showing that these selected neoepitopes are able to elicit immune responses in patients. These are even in heavily pretreated late-stage patients. Some of these, particularly in NO2, also receive few vaccinations, which increases our confidence in the platform's ability to induce immune responses. We expect to see this even further strengthened if we, in the future, move into adjuvant testing.
We see the majority of the patients having epitopes are able to induce de novo responses, meaning eliciting an immune response to epitopes that were not able to see an immune response before vaccinations. Up to 100% of the patients do see an immune response to the vaccine-induced neoantigens. We are in a good space here. Importantly, and more importantly than off-the-shelf vaccines, our manufacturing is essential to succeed in this space. We do have a robust supply chain. We have, over time, significantly improved the turnaround time. As you can see here today, the current setup allows us a robust seven-week turnaround time in clinical setting. We do also look into potential for further improvements that are tangible within a short time frame. We have an established supply chain with all vendors involved in the full turnaround time here.
We do have a clear path to also competitive cost of goods. If you can go up to next. In summary, VB10.NEO is well positioned as a best unencumbered individualized therapy. There's a huge unmet medical need. We know we can potentially treat all tumor types with this treatment, so there will be space for multiple players. We do see a readout from these multiple large randomized trials from peers expected in the next 18 months that will be definitively impacting the interest in the field of individualized therapies and also have spillover effect for off-the-shelf T-cell therapies. We do have competitive strengths. Both we have clinical data strongly in genetically and heavily pretreated patients. We do have a proprietary algorithm proven to identify the most immunogenic epitopes.
The fact that we are focusing on a plasmid DNA technology is providing us with a competitive manufacturing time as well as cost of goods, which will be essential in the future. Our robust manufacturing process is able to take proven to be able to go through this entire process from tumor sample to drug manufacturing in a robust manner. Our strategic approach now is to further strengthen this position with timely and streamlined investments aimed to further improve our competitive advantage and follow the field tightly as we move forward. We go to the next. Our tolerance program. First of all, a little background on the antigen-specific immune tolerance. What we're aiming for here is really a new way of thinking about autoimmune disease treatments. The current problem is that the treatments that are available for patients today, even the latest advancements, still focus on treating the symptoms.
They do not address the underlying root cause of the disease. That also means that there are side effects that are frequently impairing the quality of life of these patients, and it's not offering a potential cure. We have 1 out of 10 in the global population is actually affected by autoimmune diseases, meaning that the market size is huge, and there's a huge need and a huge potential for novel treatments in this space. The future, we believe, and the field believes, could be antigen-specific immune tolerance, which is a new way of addressing these diseases, addressing really the underlying cause of the autoimmune disease, which can offer the prospects of a cure. That will obviously increase the number of patients that can get a meaningful treatment and significantly improve the quality of life. We go to the next.
The approach that we are taking here is to induce fully antigen-specific immune tolerance, and that's by targeting these epitopes that are causing the disease. We do that by using our technology and making sure that these disease-causing epitopes are presented to the immune system through our APC-targeted technology in a manner that can lead to the upregulation of regulatory T cells that are focusing on down-regulating these antigen-specific disease-causing effective T cells and effective B cells. If you go to the next. This field is new. We are still looking for potential first approvals of any therapies in this space. We are seeing quite a few phase one trials, but it's still new and holds a lot of promise. What we consider the best approach here is to aim for generating the best-in-class antigen-specific immune tolerance platform.
The ideal platform in this space should aim at generating long-lasting efficacy, ideally at the late onset in the disease caused by therapy. We can see that we need this in preclinical models, and it should be with convenient dosing. So far, we have also recently presented long-lasting efficacy in the late onset model in this MS model that we are working with, with only two doses long-term efficacy. This is something we are now focusing on expanding and looking into a range of disease models to support this strong ability to change the course of the disease. Another important criteria is to generate specific regulation of not only one of the disease-causing immune cells, but all major autoreactive disease-causing cells. We have actually, in the last year, demonstrated regulation of all major autoreactive cells.
That means we have seen down-regulation of autoreactive B cells that are secreting autoreactive antibodies, as well as down-regulation of disease-causing effector T cells and upregulation of regulatory T cells. This provides us with a unique ability to further look into the versatility of our technology. We are the only company harboring a technology that can really fine-tune these immune responses by working with our APC-targeted approach and really understand what would be the optimal way of generating the perfect immune response that is leading to the most effective therapy for a range of autoimmune diseases. Another aspect in this field is that we are still working on what would be the optimal antigens across multiple of these diseases.
The ability to incorporate multiple antigens into one vaccine module and also using AI solutions in order to identify and select and combine these antigens is going to be a huge benefit for the field. We have recently shown that we can use our AI-driven epitope selection algorithm to generate these multi-antigen vaccines. We have validated that these lead into vaccine constructs that are functional in vitro, and we are now looking into demonstrating their in vivo translatability. We will continue to invest to demonstrate best-in-class technology and substantiate Nykode Therapeutics' position in this novel therapeutic area in the next period. To summarize, we are actually increasing our investments based on the latest achievements in order to develop the best-in-class antigen-specific immune tolerance platform. There's a huge unmet need. The current treatments are not optimal for the patients.
If we succeed with this field, this can be considered the holy grail of treatment in autoimmune disease therapies. We do have a range of competitive strengths in this field. Overpromising data in the preclinical models do show this long-lasting efficacy. Also in late-stage disease, we have the potential of providing the unique best-in-class modulation of the immune responses through our APC-targeted approach that we don't see with any other players in the field. Our strategic approach is to focus now really on substantiating and increasing the confidence in the platform's ability to be best-in-class, ready to then enter into drug development in the future with or without partners and establish this antigen-specific immune tolerance across a range of diseases. I think we'll hand over to Harald again.
Thank you, Agnete. We are well positioned to execute the updated strategy with a cash position of $70 million at the end of the second quarter. With disciplined execution and strong financial focus, we will reach key inflection points within the estimated cash runway into 2028. This does not include the pending tax case where we have booked a non-current receivable amounting to $32.2 million at the end of the second quarter, as described in the quarterly report. As communicated in the first quarter, we have received a letter from the tax authorities that we can expect a draft of the recommendation from the secretariat in the first quarter of 2026. Nykode is confident that we will receive a positive ruling in the tax case, also based on advice from third-party tax experts. A positive outcome would push the cash runway even further into 2029.
I will give the word back to Michael for some closing remarks.
Thank you very much. I'll just close this down before we open up for questions. I really hope you can all sense our excitement and enthusiasm with this new strategy for Nykode Therapeutics. For VB10.16, we will be initiating the randomized controlled trial, which we think this platform needs now. We'll be doing it in a large patient population with a very sizable market opportunity, and we'll be doing it with a timeline that allows us to reach meaningful interim analysis within our cash runway. For VP10.NEO, our individualized neoantigen therapy, we continue to see that market as an extremely interesting concept with several key peer readouts within the next 18 months. Some of them could come very soon.
We believe our technology is very well positioned to be one of the most attractive unencumbered assets at this time point, and we want to be in a position to leverage any shifts in the deal activity should that come. For tolerance, we continue to believe we have potential best-in-class and we will invest to strengthen that position. All of this we'll be doing on the best platform of being very well capitalized and a cost discipline that allows us to reach several meaningful inflection points within our cash runway. I think at this time point, Kevin, we are ready to close down and open up for questions from the audience.
Certainly. We'll now be conducting a question and answer session. If you'd like to ask a question at this time, please type it into the Ask a Question feature on your screen. One moment, please, while we poll for questions. Our first question today is coming from Geir Holom from DNB Carnegie. The first one is, I understand that the details of the trial design have not yet been finalized, but in broader terms, how would you define a successful outcome for this study?
Thank you very much, Geir, for these questions. As with all trials in our field, it is going to be a little bit of a collection of endpoints that we will be looking at. As you know, with these trials, the first data point that we can read out is typical objective response rate. We do see from the CO-2 trial, as well as the preliminary insights we have to the ongoing CO-3 trial, that VB10.16 or abi-suva does tend to lift the ORR compared to the standard of care alone. That is going to be a meaningful parameter to look at. As we have reported earlier, we are at least as excited, if not more excited, by the durability parameters that we see from the CO-2 trial.
We will, of course, also be looking forward to see how abi-suva on top of pembrolizumab lifts both the progression-free survival, the duration of response, and the median overall survival. The benchmark that we will need to beat in this case here is the respective data points from Keytruda alone, since that is what we will be comparing with.
Thank you. A follow-up from Geir Holom.
Geir Holom from.
This will be a follow-up from Geir Holom from DNB Carnegie. Could you please elaborate on your considerations for selecting the geographical territory or territories in which to pursue the trial, for example Europe and the U.S., and what key steps remain before initiation?
Yes. Also, very good question, Geir. We are still in the phase of planning the operational execution of this one here. We do have some optionality in terms of selecting the regions. I would advise everybody to consider Europe a key region for us to run this trial in. That's not least based on the very good experience we have from the ongoing VB-C-03 trial, which is in the same indication, first-line head and neck patients. We've had a very good experience with several of the sites across a number of countries in this trial here. It is natural to expect that we'll continue leveraging that relationship and those experiences here. We may decide to add further countries, and I'm in the process of deciding that, analyzing and deciding that right now.
We'll be able to give you more insight to that as we take those decisions over the course of the next couple of months. You also asked what the next key steps in the initiation is. First of all, we have now finalized the design of the trial here. We are discussing that with our potential partners, MSD, and have, of course, had a very good discussion with them. Also had very, very good input to the design from MSD. Next step is to submit the protocol along with supportive documentation to the authorities in Europe, as well as additional regions we might want to include into the study. We expect to be doing that over the course of the coming month through the rest of 2025.
As long as we haven't had feedback to that process, we can't give you a very precise timing for when we expect to see the first patient in. I would again here advise you to think in terms of mid-next year.
Thank you. Our next question is a follow-up from Geir. Could you also share your perspective on the competitive landscape within the relevant patient population, as well as your assessment of potentially competing assets currently in clinical development?
Yes. I would divide that question into two different types of competing assets. There are other assets in development for head and neck, including some that actually have been showing encouraging data. Our assessment and the assessments we also get from the external advisors we talk to is those assets will mainly be focusing on the HPV-negative head and neck segment for very natural reasons when you consider their mechanisms of action. We do not see those assets as the key competitors or the direct competitors in the field of HPV16-driven head and neck cancer. If you look at the field of direct competitors, that means HPV16-specific therapies, over the last couple of years, we have seen the number of competitors decrease significantly, with several of the assets failing their clinical trials and some of the companies actually no longer in operations.
We do see a few competitors that we consider our main competitors in the field here. When we compare to the data, the sparse data that have been reported from those competitors, we do think our immune responses come out on top of that one. We think we have an edge, a competitive edge in the dose regimens when comparing to what the competitors are seeing. There's so far been no data that gives us any indication that we would be coming out with inferior data, neither on immune responses, objective responses, or durability responses.
Thank you. Our next question today is coming from Elvin Haugen from Abraxis. With the current leadership in the U.S. Health Department that is pretty carefully very anti-modern vaccine technology, are you looking to run future trials in Europe instead of the U.S.?
Yes. Thank you very much, Ivan, for that question. This obviously is on my own account. I would encourage everybody to be a little bit careful putting an equal between the messages you've seen towards prophylactic vaccines directed to infectious diseases in the U.S., where I do agree there's been some very strong messages coming out from the administration. On the one hand, and on the other hand, oncology immune therapies directed towards treating advanced or locally advanced cancer types like Nykode Therapeutics is doing. I have not sensed the same level of messages from the administration directed towards immunotherapies that Nykode Therapeutics is engaged in. I do not feel that level of concern. Still, as I mentioned before to the other question, our plan right now is to conduct the next phase II trial with Europe as the core area.
We're not taking a firm decision not to include the U.S. at this time point here. As I said, based on our very good experience conducting the trial in Europe, you should see Europe as the core area for the Ability trial with abi-suva.
Thank you. Next question today is coming from Georg Tigalonov-Bjerke from ABGSC. Thank you for taking our questions. They say, can you provide any further flavor to when you expect to initiate the new randomized phase II trial? We'll stop there. There are two follow-ups.
Yes. I think we covered some of those aspects in the questions from Geir. Right now, the next step in front of us is to finalize the so-called submission package to the authorities in the countries where we want to run the trial. This is ongoing, and we expect to continue that process and submit the packages over the course of 2025 with an estimated first patient first dose around mid-2026. These timelines may change both forward and backward depending on the feedback we have from the authorities. I think that's a good estimate to be counting with at this time point, given the information we have at hand.
You elaborated on the positive on pursuing head and neck, but can you please also give some insights to potential negatives that you have within cervical cancer that may have influenced your decision?
Yes. Very good question. I want to really make sure nobody misunderstands this. We have not had any potential feedback or input regarding pursuing further development in cervical cancer. We have had both a long strategic process and, of course, also a lot of interaction with external advisors and potential future partners regarding the future development program for abi-suva. I think the combined impression that we have is that in the area or in the indication of cervical cancer, we have already very strong data from the CO-2 trial, which provides very strong support and indication of effect and very meaningful effect on top of standard of care in that patient segment. On top of that, we have very strong indications from the CO-1 trial in the premalignant setting, also as monotherapy.
The gaps we had for the development programs for abi-suva was to basically show effect in the head and neck segment, which is a larger segment when you look at the number of patients, both in advanced as well as in the locally advanced. The other gap we clearly had was randomized controlled data. That's why we, with this new phase II trial Ability, closed those two remaining gaps. We provide randomized clinical data showing the effect of abi-suva on top of standard of care in a direct head-to-head comparison against standard of care. We do it in head and neck, which is the largest segment or the largest potential for this treatment or this therapy here for abi-suva. That's why we've chosen this indication. It is not because we do not consider cervical cancer as an important indication going forward.
We just feel we have provided enough data there, and it's more important for us to close the gap on the head and neck.
A further follow-up from Georg from ABGSC. Can you give any insight into which limits remain and what kind of decisions you are currently having with Regeneron in relation to the termination of the collaboration?
Thank you very much, Georg, for that. I'm going to hand over to Agnete for answering that question.
At the current stage, we can't say much more than that we have ended the discussions with Regeneron and advised to take it off the balance sheet of Nykode. It is not terminated. That's important. Today, we are in discussions with Regeneron about the future of the program.
Further follow-up. How do you assess VP10.NEO in the individualized cancer therapy landscape?
Yeah. That's a good question. I'll try to be brief. The field is today dominated by a couple of players, which are the two companies that have received a high cash income during the COVID period with the sales of prophylactic COVID vaccines. They have moved forward. They're both partnered, and they have moved forward with great confidence investing in multiple large phase II and phase III trials. Actually, on the back of quite limited data as of today, Moderna has presented a randomized phase II trial in melanoma in an adjuvant setting that is promising. BioNTech basically based their future investments on a small investigator-initiated trial in PDAC with 16 patients. The upcoming period is going to be extremely interesting to see if those early signs will pan out. We will see readouts from so many big randomized trials.
This will give us proof on whether the concept works, but importantly also whether the concept works with mRNA-based vaccines. Two different kinds of mRNA-based vaccines, they are quite different in their mode of action, Moderna and BioNTech. When it comes to our position compared to those, these vaccines have also been tested in a later stage advanced disease without being convincing clinical improvement and have moved to adjuvant setting. That is one important aspect. Another aspect is the importance of the turnaround time and the cost of goods, where plasmid DNA-based vaccines, per definition, have a quite strong edge compared to mRNA-based vaccines. There are also a few other players, but as we've also seen in the HPV field, there's been a reduction in the number of players that are active in the field of individualized cancer vaccines as well over the last few years.
We have also seen these companies focusing on viral vectors, including Gritstone. They are no longer in operation. We do believe we have a nice edge here. Very few companies have their own proprietary algorithm to select the antigens as well as a proven supply chain with an already proven effective turnaround time and with the prospects of being very competitive on cost of goods, in addition to having clinical data. Even in the advanced setting, NO-2, you may have seen at a median line of prior therapy of five. At the very other range of the disease progression compared to adjuvant settings, where they focus on treating patients after basically having reduced the tumor mass to close to nothing. We believe we are one of very few players that will be there.
Based on historically how the pharma world operates, if we see positive outcomes from the readouts that will come in the next few months, we would expect increased interest in alternative players with improved technologies and improved patent comps from other potential pharma partners out there. We hope we're in good shape, depending on the outcome of the peer readout.
Thank you. Our next question is coming from Alexandra Eckelson from Superstar AS. They would like an update on Genentech.
Yeah. Genentech is no longer a collaboration partner of us. They have basically reduced their investments in cancer immunotherapy dramatically over the years that you've seen. They also closed down other collaborations. We do, as you saw also in June, have still a good collaboration with the Genentech team. We have now presented the key data from the NO2 trial that we did in collaboration with Genentech, which was very important for us. We don't foresee any future payments in any directions from Genentech and Nykode. You can basically see that you can consider this as a more or less finalized breakup where we have the right to the product and we have been able to release the core data of importance for us.
Thank you. We reached the end of our question and answer session. I'd like to turn the floor back over for any further or closing comments.
Thank you very much, Kevin. Thank you very much for listening in, and thank you for the questions. Once again, we're very happy to announce this strategy today, which we believe is a very exciting new path forward for the company. We look forward to get to work, start executing, and also re-engage with all of you over the coming period. Wish you all a good day.
Bye.
Thank you. That does conclude today's webcast. We disconnect from the line at this time and have a wonderful day. We thank you for your participation today.