Nykode Therapeutics ASA

OSE:NYKD

Earnings Call Analysis

Earnings Call Transcript 2024-Q2

[Operator]

Greetings, and welcome to the Nykode Therapeutics Q2 2024 Financial Results Presentation. [Operator Instructions] As a reminder, this conference is being recorded.

It's now my pleasure to introduce your host, CEO, Michael Engsig. Please go ahead, sir.

[Michael Engsig, executive]

Thank you very much, Kevin and also from our side, a very warm welcome to all participants at this webcast to go through the second quarter of Nykodes. Of course, with me today, I'm pleased to have Agnete Fredriksen, Chief Scientific Officer and Head of Business Development. Harald Gurvin, our Chief Finalcial Officer; and Klaus Edvardsen, Head of Research and Development.

We assume your're all familiar with our forward-looking statements. So on that note, we'll just quickly skip forward. So as first quarter has been another eventful quarter. And in addition to that, we have this morning also announced a strategic repositioning, which we'll take you further through. So I'm going to give you a brief run-on of the key highlights, and then I'm going to hand over towards to Klaus to take us into the rationale and thinking behind our repositioning then going to hand over the word to Agnete to take you through some of the exciting updates we have from our technology platform. And finally, Harald will take us through the financial highlights.

This morning, we announced a strategic repositioning of our VB10.16 development plan to refocus the program on 2 key indications, locally advanced cervical cancer and recurrent, or metastatic head and neck cervical cancer. And this decision comes on the back of very positive data and sorry, feedback from our key opinion leaders as well as potential future partners regarding these indications. These 2 indications have been chosen by us because they do represent areas where we see a large unmet medical need as well as a significant commercial potential.

We have consequently decided to discontinue the C-04 trial. And that decision comes on the back of changes in the dynamics related to the standard of care which was impacting the timing of the trial, which in the ends, put some challenges to the whole strategic rationale of our fast-to-market strategy VB10.16 in the recurrent, metastatic cervical cancer, and we, therefore, decided to allocate the funding to the locally advanced cervical cancer and the metastatic head and neck cancer because we think they represent more valuable areas for the company. We have also -- to further emphasize the positive sentiment around the locally advanced cervical cancer area announced during the second quarter, the agreement with MSD to supply KEYTRUDA, our C-05 trial will be our first trial into the locally advanced cervical cancer treatment. I will have Klaus tell us more about the background and the rationale and our enthusiasm for that trial when I hand over the word to him.

Further along the decisions to re-evaluate our allocation of funding, we have decided also to discontinue further activities on the NYK011 preclinical program. And that also comes as a consequence also our focus to really concentrate our both capital and human resources within the oncology segment on our partner and programs and our clinical assets.

We have a key patent issued in the U.S. around our individualized neoantigen-based vaccines, Agnete will tell us about that patent when we hand over the word to her. Then we had -- we presented very exciting data from our APC target neoantigen vaccines in the mRNA [ format ], which shows again a superiority over antigen alone vaccines formulated by mRNA. We've presented advancements in the inverse vaccine platform, which is our use of the technology within the autoimmune disease area which highlights the versatility and effectiveness of Nykode's [ vaccine targeting ] technology in, in this area. And we have revealed plans to form a new subsidiary focused on advancing our immune tolerance platform further.

If we're taking the next slide. Again, a quick look at the pipeline. Which have been modified to reflect to this refocusing. So again, you want to emphasize or bringing the attention to VB10.16, our lead assets. And here again, I want to emphasize, we continue to have a very high level of conviction in VB10.16 to benefit patients across a range of diseases, obviously, now focusing on head and neck and locally advanced, as I said before, update you a little bit more on the programs as they are running when we hand over the word to Klaus.

Also exciting development on our other programs, [ now at least ] the regimen programs that are still moving forward as well as our partnership with Genentech.

With those words, I'll hand over to Klaus to take us through the strategic repositioning of VB10.16.

[Klaus Edvardsen, executive]

Thank you, Michael. Klaus here. Good afternoon. Good morning to everyone. Obviously, the R&D update today will focus primarily o the announcement that was made this morning to discontinue the VB-C-04 trial. Let me just state upfront that this decision is not based on any data that is indicating that we should [ use ] sales in VB10.16 nor any safety data. It is a strategic decision that is purely made for feasibility reasons. And let me try to give you a bit of context for what those feasibility situation is. We have every confidence that we would have been capable of recruiting this trial to completion, but we have to accept that we will be faced with significant delays and therefore, have made the strategic decision that those delays are not acceptable for a strategy that was set out as the fastest to market authorization possibility. And therefore, we decided to stop at this stage and reallocate resources, as Michael mentioned, to the locally advanced cervical cancer as well as the recurrent, metastatic head and neck cancer.

But let me just stay honest to the slide and say that what we have been faced with that has been taking us with a bit of surprise is that the recruitment numbers at this stage are not where they need to be. And that is primarily based on the reason that we are seeing the consequences of a full approval of TIVDAK, Obviously, a compound that we were fully aware was present and has not changed the number of prescriptions necessarily filled for TIVDAK or change the dynamic of the patient flow understood in that fashion that patients with recurrent, metastatic cervical cancer is very often entering into the health care system in community hospitals. And then used to be referred to tertiary cancer centers that are obviously GOG centers and data centers where our partners would see the patients. What seems to have happened now with an element of this judgment, obviously, from our side is that, that referral is not happening to the degree that we would have expected it to happen. And that's obviously a dynamic of patient flow that Nykode and for that matter, GOG would have difficult in changing and therefore, we came up with the strategic reposition of the program because the fast of -- the fastest to market strategy has somewhat disappeared.

If I can have the next slide. I just want to remind everyone that we have always been guiding the market to say that obviously, we built a strategy with a fast-to-market strategy, that's the CFO strategy that I just described. But very intimately linked into that strategy was also to capture a patient population with an equally high unmet need locally advanced cervical cancer, which is a patient population is larger than the recurrent metastatic. And if we really look at the data that we have available from the C-02 trial, that we have shared interim data with you and also guided you that when the final results from that trial was made out that we closely mirrored the interim data we decided not to give you any numbers from the actual trial. I will, although for this call, allude to why the C-02 results were not only important for C-04 but actually more important than reality for the strategy in locally advanced. If you look at the very simple data set or maybe not that simple because it is [indiscernible], if you like. It is, in essence, showing in color blue, patients that did not have what's called an objective response, meaning they would have had a tumor reduction of at least 25%.

On the other side of the [indiscernible] shown in red patients that actually did have an objective response in the C-02 filing trial, meaning that they would have had a reduction of their originally tumor sites of more than 25%.

What you also would see on this slide is that obviously, the reds are being a much deeper fall down of the curve. That's because of the response on the tumor. On the blue, you would not see as deep adoption of the tumor, but you would -- in essence, for a majority of patients see a flat curve meaning that adding the vaccine to standard of care and that experiment led to maintaining of the clinical effect irrespectively of whether that clinical effect was a response or a stabilization.

If you think about locally advanced disease in an adjuvant setting, where you in essence treat patients with the definitive treatment. And then you have preselected patients for effects and then you vaccinate them if I can use that terminology. And therefore, the C-02 data very, very nicely support we would go into the C-05 trial with an expectation that the vaccine will add a significant more effect than we would have obtained by standard of care.

Next slide, please. So as Michael alluded, and I also alluded to the growth will stop C-04 with the aim of focusing on primarily locally advanced cervical cancer. We have already communicated to the market that this is not something that we are in the early planning stages of. We have announced that we did signed a supply agreement with our team for partner Merck MSD. And we are imminently ready to release the final design of that locally advanced C-05 trial. And would obviously advance that through the fast possible degree based on the decision of not continuing C-04.

And by that, I hand it over to Agnete.

[Agnete Fredriksen, executive]

Thank you, Klaus. Then we move forward to the VB10.NEO program and program and the update [indiscernible] loss update. A reminder here briefly, the VB10.NEO in our individualized cancer vaccine. This is where we define 1 vaccine per patient by using through sequencing or [indiscernible] much each patient manufacturing [indiscernible] in the patients. This program, as you are aware of, is exclusively out-licensed to Genentech.

And if you go to the next slide, very important factor of partnership deals as the one we have built, Genentech is the basis of our patent protection for the product. And we are very happy to see we could obtain a grant of this patent for VB10. NEO also now in the U.S. We mentioned this particularly because U.S. is then the biggest market for these kind of treatments and obviously also the country where our partner Genentech is situated.

This is also a patent that is not necessarily straightforward, but is one of the pioneers in this field and to get the ground for a products that is also based on the process of how to design and manufacture these vaccines for each patient, is a challenge and is then also very good to see we have now obtained a grant in these important countries. And this gives us also an expiration for -- the patent will last until January 2037. Important for also the terms in the deal with our partner, Genentech.

Think we can move forward to update on the mRNA oncology vaccine. As you know, Michael has so far focused in the clinical programs based on the plasmid DNA format. We are a technology company, which is based on using a targeted delivery to antigen presenting cells, which, in principle, is broader than the use of the plasmid DNA format for constructing and manufacturing and delivering this kind of vaccine. So we have recently been shown as demonstrated before, then we can also make the APC targeted vaccines that are proprietary to micro as mRNA. And we've also seen that we can improve the number of immunogenic antigens versus the standard antigen alone approaches, which is what we normally see with the mRNA vaccines that you see from other competitors in the field.

A New data now from second quarter, which I will go into in a bit more detail in the subsequent slides, is further substantiating this improved immunogenicity and now across a range of different doses. We still see the superiority and also different time frames. We can also show that the buyers of the Nykode's APC targeted technology versus antigen alone is focusing on a bias to [ T cell in terms of ] responses. And we now also can see that this translates into superior tumor control. So very important data to substantiate the opportunity for Nykode also to be a strong competitor to other mRNA general approaches.

If you go to the next slide, this is one of the data sets that we presented in Q2 where we can see here, at the bottom, you can see across different dose levels. So we see an enhanced response actually a response is significant even after single vaccination and low doses. And you can see that increasing the doses, we continue to see a strong benefit of the strength of the T cell response. This is what you see on the y-axis here across all doses, and you never see these dose -- these 2 curves cross meaning we have maintained the benefit across all doses.

That's also true for the panel to the right, where we have then vaccinated twice. And you can see that we can see a very strong efficacy increase with the Vaccibody versus the antigen alone, particularly with very low doses, so relevant for the clinic moving forward.

When we go to the next slide, we have shown before that we see an increased breadth, meaning that there are for instance, individualized cancer vaccine settings is where we predicted and include normally up to, for instance, 20 NEO epitopes into 1 vaccine. And we always wish to have as many of these NEO epitopes actually translating into a antigen-specific immune response in the patients and here, we show that we can up to double the number of NEO epitopes that are immunogenic compared to the antigen alone vaccines. Again, we see the antigen alone vaccine is not catching up to the same level of breadth with high doses.

To the right, you can see this skewing. So you see the immune response is highly focused on CD8 T cell responses versus the CD4 help with T cell responses, but obviously, we also find it important that we do see some CD4 responses. The number of the colors on the column indicates the same breadth that you see on the other slide, so you can see more color, meaning that there are more targets for the CD8 T cells to recognize on the tumor cells.

And then finally, in the slide, we can see that the -- this enhanced immune responses that we've looked into in detail actually translates into superior tumor control, where we see a statistically significant difference between the ability [indiscernible] vaccines with exactly the same set of antigens and translates into a tumor efficacy, while we don't see a statistically significant protection here with the antigen alone vaccine.

So this is always a question whether we are moving into being an mRNA vaccine company. For us, this is about taking a basis and knowing that our technology works across different formats and formulations. It is super helpful for us to show the direct efficacy of the antigen presenting cell technology, the targeting, the antigen presenting cell here also across different formats and formulations. And importantly, it provides a basis for a much broader set of potential partner discussions.

[Operator]

Please hold, experiencing technical difficulties. Please hold, we will connect you in one moment. Please continue to hold everyone, do not disconnect. We'll connect our speakers back momentarily.

[Technical Difficulty]

[Agnete Fredriksen, executive]

Yes. I'm sorry for that. We lost connection here from the office, and now we're back. I think you heard through the mRNA session. So let's move on to the autommunity platform update. I think you can go to the next slide.

So just a short reminder of our immune tolerance platform, our inverse vaccine is building on the years of experience with the APC targeted technology, but we've been an important twist. So we changed certain parts of the technology to make sure that the antigens in this case is directed to a different subsets of antigen presenting cells in order to then control that the immune response goes in the direction of -- in using tolerance against the specific antigens, including the vaccine and not stimulating immune response that we focused on in this call up until now.

I think we can go to the next slide. And Michael has also in Q2, been at the conference and presented some updated data, which continue to highlight the benefit of using the APC targeted technology for this -- in these preclinical models for autoimmune diseases, we have now tested here two different targeting units. So as you know, we have the opportunity to use different targeting units, which will make sure that the antigens are directed to different receptors on different subsets of antigen presenting cells. And by that, we can see the end result being different immune responses against the antigen included. So here using 2 different targeting units that we believe could be [ immune ] tolerance, and we see that it is possible to do this and then we can go to the next slide.

This is where we see these 2 different targeting units. And we can also see -- actually, I have to go back. One I think here is actually the focus on how this separates from the antigen alone vaccine so we can see here in a pretty late stage disease where the [indiscernible] have actually developed signs of disease with an EAE score here of 1. We can see that antigen alone here in black is not able to show any therapeutic efficacy, but we do see therapeutic efficacy with a high dose of our vaccine.

So it's showing, we can induce this effect in [ mind ] or even 1 step, figure than what we've shown before.

And in the next slide [ 10 ], we have been repeated this experiment with 2 vaccidbodies that have different targeting and is as I alluded to before and see a strategically significant durable, long-lasting effects in an early therapeutic setting.

So we go to the next slide. The new data, I think highlight the versatility and the effectiveness of our APC targeted technology which we believe has broad applicability across the [indiscernible] intolerance. This is a preclinical models, but the mechanisms of actions, we believe, can be incorporated, again for autoimmune diseases, potentially allergy, organ transplant rejections, et cetera in the future. So these are models that we believe is very important for the future of a broad set of potential product development.

We have also announced in this quarter that we have taken a step and establishing a subsidiary that is focusing on immune tolerance in order to put our efforts into advancing this showing then we believe that this subset of our technology has a lot of value by itself and get enough attention and visibility out there for using to -- continue to benefit patients as well as providing shareholder value.

I think we can go to the next, I think I will then hand over to you, Harald.

[Harald Gurvin, executive]

Thank you, Agnete. Looking at the income statement. We reported total revenue of close to $600,000 in the second quarter, of which $540,000 related to R&D activities delivered under agreements with Genentech and Regeneron. Employee benefit expenses were $5.7 million in the second quarter, up from $5.1 million in the previous quarter [indiscernible] for the same period in '23, reflecting the growth in the organization.

Other operating expenses, [ we used $0.6 million ], down from $11.4 million in the same period in 2023. Mainly reflecting reduced costs following finalization of enrollment under [ VB-C-03 ] trial.

Finance income was $2.9 million in the quarter, which mainly relates to interest income while finance cost of $0.6 million, mainly related to unrealized currency losses on Norwegian kroner exposure. So overall, we recorded a net loss of $7.4 million for the second quarter.

Then moving on to the balance sheet. We had a strong cash position of $136.5 million at the quarter end. As previously communicated, we received a decision from the Norwegian tax authorities in the fourth quarter of '23, where they reiterated a position other from payments received on our license agreement entered into in 2020, should be recognized as taxable income in full in 2020 rather than the user taxable gain/loss account.

The decision generated a payable of approximately $30 million in the fourth of '23, and Nykode is confident that the use of flexible gain/loss account is the correct treatment of that from payment. And we view this also being confirmed by third-party tax experts. Nykode has appealed the decision and the payment has been booked as a receivable by await the outcome of the appeal.

Next slide, please. Then moving on to equity and liabilities. We had total equity of $152 million, which represents a strong equity ratio, 85%. And with that, I will give the word back to Michael.

[Michael Engsig, executive]

Thank you very much, Harald. Just to finish off with the outlook for the period. as i said at the beginning, it has been a period, I think 2024, very important year for VB10.16. We reported the very encouraging final conclusion from the C-02 trial, which as Klaus told you earlier today, closely mirrors the conclusions we have seen from the interim, which again points to very strong clinical effect, a very strong immune responses, which translates to durable responses. We are, despite the decision to discontinue C-04, very committed to advancing VB10.16 as our lead asset into the areas of locally advanced cervical cancer as well as head and neck within the latter. We have already started the C-03 trial, and we expect to be able to select the recommended Phase II dose in the [ P-01 ] positive patients from first line [indiscernible] direct head and neck towards the end of the year. And this, of course, will be an important data point information for us as we design the next phase or next part of the head and neck program.

In the autoimmune disease field, we have already this year been reporting quite a number of very encouraging data that speaks to the concept and feasibility, and we continue to push forward, generating more information and data around that technology, and look forward to keep you all posted as we progress forward towards selecting both indication and the plan and the path forward.

Also, in the mRNA space, we continue to see exciting data and are still investing resources and exploring and on what we can do in that area. And we'll, of course, also take this into context for a partnering strategy, and we also here look forward to be updating you with further news and data towards the same part of this year.

So exciting times ahead of us. And despite the news around the discontinuation of C-04 today, I hope you appreciate our own conviction and enthusiasm for VB10.16. We believe we have a unique product here that has the potential to provide benefits for patients across a range of indications and are as committed as ever taking this asset forward in the very attractive areas of locally advanced cervical cancer as well as head and neck, not least based on the positive feedback and input we've had from the external community, both the medical environment and potential future partners.

And with those words, I think we are at the end of the formal presentation and can open up for questions, Kevin.

[Operator]

[Operator Instructions]. Our first question is coming from Geir Holom from DNB.

In light of the discontinuation of the C-04 trial, has your partnership strategy for the VB10.16 asset change in any way? More specifically, is the company more willing to end commercial partnership earlier than before? Is it likely that a partnership can materialize before the C-05 trial initiation?

[Michael Engsig, executive]

Thank you very much for that question, Geir. And just to confirm and to a extent, it's a change, I'm not sure. But we do consider partnership a very important strategic element of our VB10.16 program and are definitely exploring every opportunity of getting a partner on board, both because we think the partner will contribute with competencies, but also more specifically to offload the development costs. So yes, we are looking for a strategic partner for VB10.16, at least, I can say, not unlikely, then we can define likely that a partnership could materialize before a C-05 trial will be initiated by [ Regeneron ] speculative likelihood of that happening. Then will take the next question.

[Operator]

A follow-up from Gier is going to be regarding the Genentech partnership, following the reorganization, you said that you have not received any indications of the partnership being affected, that's a quote. But have you received any reassurance or confirmation that the partnership is unaffected and still prioritized? Could you make any more comment to reassure investors that are concerned following the news?

[Michael Engsig, executive]

Yes. Again, also thanks, Gier. And I'm always a little bit mindful speaking on behalf of other companies, still for those of you who have not followed the news which are relevant for Nykode. I'll just remind everybody that it was announced that Ira Mellman will be leaving Genentech and there will be some reorganization in Genentech. I fully appreciate that has caused some concern, especially in the capital market. So let me see if I can put that to rest. We did receive upfront notice that Ira Mellman was leaving Genentech. We also informed that this was happening as part of a reorganization, but we have further been informed by our partners Genentech is that the reorganization does not reflect a strategic change from Genentech when it comes to autoimmune therapy. They remain committed to the area and they remain committed to cancer vaccines and what we have told relating to our own program is that it is business as usual. And I think this is as much as you can expect, a partnership, a partner to communicate in this kind situations. We are set on a personal level to see our Ira Mellman leave, Ira have been a very, very good partner for us for all the years. But at this time point, a partnership with Genentech of this nature is much broader than hinged on 1 person. So we look forward to continue the very fruitful collaboration we've had with Genentech with a range of people including senior executives that we have built up over the last couple of years. So from our perspective, we do not see this in any way changing the collaboration or the conviction from Genentech. We have the next question?

[Operator]

Sure, a follow-up from Gier from DNB, is going to be regarding the Regeneron partnership, could you please comment on the status and progress of this partnership?

[Michael Engsig, executive]

Klaus, I don't want to add more because again, we're not in control. But I think from our perspective, we can say...

[Klaus Edvardsen, executive]

Thank you for the question, Gier. Again, I mean, I can say that from the Nycode perspective and what Nycode is and has been supposed to deliver into that partnership is all taken care of. And I have every indication that Regeneron is moving the programs forward with the speeds that they have also indicated to us. But on the exact status programs. I cannot comment that is a Regeneron element. What I can say is that the [ deliverables ] agreed in contract and in partnership discussions from micro to Regeneron has been delivered fully that time.

[Michael Engsig, executive]

So we remain very happy with the partnership.

[Operator]

Final follow-up is going to be from Gier will be, would you consider downsizing the organization to preserve cash and extend runway?

[Michael Engsig, executive]

I appreciate the question, Gier. And I hope you will also appreciate that for us, this is a very new position that we are communicating fresh out of the press. So we are still assessing what should be the consequences of the decision to discontinue C-04. And we'll, of course, communicate to the organization, first and foremost, if anything should materialize on that. So I am not in a position to comment on that further at this call here.

[Operator]

Our next question today is coming from Lucy Codrington from Jefferies.

Given the C-04 interim readout mid-2025 had been flagged as a potential trigger for partnership discussions. What could be the next key clinical readout for VB10.16 since my understanding is that the efficacy data for C-05 are unlikely before 2026.

[Klaus Edvardsen, executive]

Thank you, Lucy, for the question. I will not, at this time comment on when the locally advanced cervical cancer data will be available as I indicated under my presentation we will have the final design done right after the ESMO meeting, there is some important elements that we do need to have released at the ESMO meeting, which is in mid-September in Barcelona. What I can say is, obviously, that we are fully aware that we will take into account when we do that final design of the trial that we would have a meaningful interim analysis as fast as we possibly can in that trial concept without jeopardizing the final read for the trial so that we can guide that we are where we think we need to be with regard to a positive outcome in locally advanced cervical cancer.

Next clinical readout will be near end of this year or slightly in the beginning of the new when we read out dose finding and final dose recommendation in the head and neck cancer and trial C-03.

[Operator]

And a follow-up from Lucy is, could the C-05 trial design include a potential interim look to derisk the trial as was planned for the C-04?

[Michael Engsig, executive]

I didn't have a magical booth. I think I answered that question before, it will have an interim analysis. But I cannot comment on the details at this meeting, as I alluded to, we are in the final stages of settling the design. But we'll obviously guide on that as soon as we communicate the final decide together with Merck.

[Operator]

And a follow-up, Lucy from Jefferies is, what is the status of the VB10.NEO patent in Europe?

[Agnete Fredriksen, executive]

Yes. So the update in this quarter was that we received a grant in U.S., and you can also see in the slides that this patent is approved in few other countries, including Russia, India and Australia out by now. We have filed in Europe. So we are then going through the office actions and will inform you once it will be granted.

[Operator]

And a further follow-up, Lucy Codrington from Jefferies. Has the experience in cervical cancer changing development plans for H&N cancer? For example, whether to also prioritize locally advanced over recurrent metastatic?

[Michael Engsig, executive]

Sorry, is the question whether the change in cervical cancer is our strategy in head and neck cancer? No, that -- I mean the change in strategy in cervical cancer is, as I said, purely driven by a feasibility aspect that was not expected upfront. And let me be very clear that, obviously, we were fully aware of TIVDAK as I also tried to say patients and the uptake of TIVDAK, I'm not having any evidence that has changed what has changed and was not really foreseen based on all of the available feasibility data we had and our partner GOG, that is recruiting on our behalf and was not indicating that patient dynamic and patient flow should have changed meaning that the patients are not referred to the centers that we are engaged with GOG, they are staying in community practice and being treated with TIVDAK. That dynamic is maybe not unprecedented, but something that was not foreseeable, obviously, became foreseeable as soon as we open sites that we're able to have those patients. The patients are simply not referred into the center that we have the trial C-04 ongoing with -- so we are not having any other driver for the strategic change. We are fully committed, fully believing in VB10.16. We are fully engaged in making sure that we make this medicine available potentially, of course, I have to say, because it will have to go as a trial and approval process. Our strategy in cervical cancer will change a bit, I have talked enough about that. Our head and neck cancer strategy is not going to change. But obviously, we have to do this in the right order. We will, as also communicated this morning, advance our efforts in recurrent, metastatic head and neck cancer. And as we have guided on earlier, we will, at the right time, also advance into locally advanced head and neck cancer, but that's not in the plan immediately.

[Agnete Fredriksen, executive]

So I can just add to that answer from Klaus that, we should not forget that the C-02 data has been performed and the C-02 trial was performed in recurrent, metastatic cervical cancer patients, second line and beyond. And we do see signs of clinical ubiquity and also the safety profile there. So the change as Klaus alluded to moving from the second line to locally advanced cervical cancer. So it does not reflect that we believe that we will not be able to provide a meaningful clinical efficacy also in recurrent, metastatic settings, we remain confident that we have a broader potential.

[Operator]

Our next few questions today are coming from Sebastian [ Van Der Schulz ] from Kempen.

The first 2 are going to focus on the dose escalation data for 1L R/M HNSCC. Could you provide some insight into what to expect -- I'm sorry, into what the expected data set for the dose escalation part will exactly contain around YE '24 interested whether you will also be able to share efficacy data at that time point.

[Michael Engsig, executive]

Obviously, dose escalation is, in essence, 3 -- potentially 3 plus 3 patients at each of the dose levels tested out. So that it is primarily to establish whether any of the doses that we are testing 3, 6 and 9-milligram would be safe to give. But obviously, you will have what responses the patient eventually may obtain or not obtain that I cannot speculate on now because I do not know the data. But there will not be data in the sense that you can say anything meaningful. It will be on a smaller patient number, but will obviously be an important guidance internally for which those you eventually would like to move forward.

[Operator]

And again, referring to a dose escalation data for 1L R/M HNSCC. How do the recent results from other vaccine companies in 1L R/M HNSCC [indiscernible] I believe it's called at ASCO, change thinking about how to strategically position the program in 1L HNSCC.

[Michael Engsig, executive]

It's not changing our speculations, and let me qualify that. I mean, first and foremost, any element that indicate that cancer vaccine basin is the right approach is the validation of what we're doing. We have confidence in our vaccine. I think one of the elements that needs to be fully understood in head and neck cancer is that you have 2 options. You either position your third compound in the very high PD-L1 expressions there you can do monotherapy setting with atezolizumab or another checkpoint inhibitor and add your vaccine to that design or you can try to take more into account lesser PD-L1 expression levels and combine that chemotherapy. I am not to comment on development programs for other companies but I think there could be a distinction in direct comparison with the company that question here, whether the PD-L1 expression cutoff label would be the right cutoff level. So we are not hesitating in believing that we can position our compound in the head and neck cancer space irrespectively of the competitive field.

[Operator]

And our next question is a follow-up from Sebastian. Regarding the collaboration with Genentech on VB10.NEO. I understand that you're restricted in communication, but would you be great to get some color on how to program -- how the program has been progressing clinically? Also, do you have insight into the data that has been generated in the clinical trial? Or what is the extent of your knowledge on the clinical trial results? And also although, there is no sign of discontinuation of the Genentech ship, we wonder whether you would share the Phase I data generated, if it were to be returned?

[Michael Engsig, executive]

Let me not speculate about any discontinuation because that is not in scope. We have already, as Michael indicated, no indication that anything is changing, except Ira Mellman is leaving, which we regret but it is business as usual. We have an exclusive partnership with Genentech on personalized DNA-based vaccine, and it continues. So I will not speculate about any situation after discontinuation because that's not what we are discussing. I can say, and that is a known that recruitment in the N-02 NEO program with Genentech has completed. I am not aware of the data because the analysis is ongoing, and it is Genentech's sole discretion whether that -- on when that data set will be released. I cannot get it any closer and that's not to sound as a broken record. But it is the way the partnership is structured. This is the ownership of Genentech. But the progress is as expected and as I said, recruitment finalized.

[Operator]

We have another follow-up from Sebastian [ Van Der Schulz ] from Kempen. Can you provide some insight into how easy it is to recruit 1L R/M HNSCC patients relative to 2L R/M cervical patients. Do you expect this to change given the number of agents that are expected to enter larger Phase III studies within the near term?

[Michael Engsig, executive]

I mean, yes, there is a competition on patients for any trial concept. I would just address it in a way that I don't think you in general terms, can make a cross indication comparison. It is very individual. Let me see if the background for the question is that we have not landed where we would like to land on C-04 that we have been clearly transparent, communicating to you, we have also been giving you the reason for it. That is a very unprecedented reason with a compound that has been around for 2 years on an accelerated approval and obtained in April a full approval. The patient dynamic element of community practices to cervical cancer center is not something that we expected nor our partner expected. So I won't make any equalization about whether that will repeat in head and neck cancer. It will not because that situation is non-existing in head and make cancer. It doesn't mean that there is no competition but again, we are behind VB10.16, we think based on the data that we have released. We are still awaiting the full data set release, but that will be released in a scientific publication. But as we have also indicated, you have in essence seen the data based on the interim data because we have communicated that we closely mirror that interim data. That we are well positioned to compete about patients and recruitment in the settings where we strategically have placed in VB10.16.

[Operator]

Your next question today is coming from Alexander Krämer from ABGSC.

Could you elaborate on a potential time line to market for the locally advanced cervical cancer setting. Also thinking about potential to accelerated approval, how do you see the commercial opportunity patient population in locally advanced cervical cancer compared to the C-04 setting?

[Michael Engsig, executive]

I can start answering the question bottom up. It is a larger patient population. I do not have the exact number on top of my head. But it is a significantly larger patient population in the locally advanced. That is obviously a driver. The driver is primarily patient need and as I said, we regret that we are not capable of positioning our vaccine in recurrent metastatic cervical cancer because the patients there have an unmet need. As patients do have an unmet need in locally advanced cervical cancer. But if the question directly on the commercial opportunity, then yes, it is a bigger opportunity in the locally advanced setting, I am not going to give you a date for when we expect to have definitive data in locally advanced. I did allude to the fact that we are 99% ready with the design. We need the last elements. And I also alluded to the fact that we are obviously bluntly aware that an interim analysis that can give a meaningful guidance is needed. Without jeopardizing the final results. I will be happy to guide on exact time lines when we have announced the final design with this imminently.

[Operator]

Our next question today is coming from Arvid Necander from Carnegie.

Can you explain how the different factors were ranked in the decision to discontinue VB-C-04 ? Was the main reason the commercial potential or did scientific evidence showing better results in earlier stage disease carry more weight? And there is a subset. How far our ongoing programs sprung out of the autoimmune platform from being partnership, partnering ready?

[Michael Engsig, executive]

Yes. I will deal with the first part of the question and make sure Agnete deals with the second part. I think I already answered it. The commercial element did not pay any part in the decision making. As I said, we are driven by the unmet need. And the unmet need is existing is recurrent. It is existing in locally advanced. So yes, the local advance will be a bigger commercial opportunity, but that was not the factor that was involved in making the decision. It was purely feasibility decision that we did not feel that it was the right way of spending Nykode resources and money on something where the fast-to-market elements lost fast. And that was #1 driver and, in essence, only the driver for the decision making.

[Agnete Fredriksen, executive]

And then I can add on the autoimmune platform program. So they are, as you see, with [indiscernible] updates moving forward. I could speak -- as we are speaking, there are multiple experiments running. We are in contact with a lot of potential partners here already. This is a field that is of interest for big pharma, and we've also seen a deal at a preclinical stage in the same space coming in the last 6 months. So this -- whether or not, this partnering, that is always a definition as to what we want to see and what a potential partner wants to see that is not unlikely that there would be an opportunity to partner some autoimmune disease programs at an early stage. And I think we have alluded to already a year ago that this is a platform, and we will continuously evaluate the best partnering strategy for this system also in the past with the oncology platform.

[Operator]

We reached the end of our question-and-answer session. I'd like to turn the floor back over to Michael for any further or closing comments.

[Michael Engsig, executive]

Thank you very much, Kevin. I'd like also to thank my colleagues here and all the participants dialing in to this call this afternoon. We look forward to give you update on the progress on all our programs. And with those words, I wish you a very good day.

[Operator]

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.