Greetings, and welcome to the Nykode Therapeutics Q1 2024 financial results presentation. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If any which require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce Chief Executive Officer, Michael Engsig. Thank you. You may begin.
Thank you very much, Daryl, and to all the participants, a very warm welcome to this Q1 report. We assume you're all familiar with our forward-looking statement, and on that note, we'll move forward. I am very pleased to have with me here today Agnete Fredriksen, our Chief Scientific Officer, Head of Business Development and Co-Founder, our Harald Gurvin, our Chief Financial Officer, and Klaus Edvardsen, our Chief Research and Development Officer. And together, we will take you through the highlights of the quarter, as well as the financial results. A quick look as an introduction from my side. First quarter was yet another exciting quarter with very solid progress for Nykode.
We presented the very important top line conclusions from the updated analysis from our phase II VB-C-02 trial in advanced cervical cancer, which affirmed the prolonged benefits and indicating a synergistic treatment effect of VB10.16 in combination with atezolizumab. We also announced the advances in our inverse vaccine platform with a potential use in autoimmune diseases, showing promising results in treating autoimmune diseases and underscoring the platform's potential. We presented additional preclinical data on the inverse vaccine platform towards the end of the quarter, also demonstrating long-term protection against diabetes following treatment withdrawals. Post the first quarter, we had further progress, so we initiated the phase II VB-C-04 trial in second-line HPV16-positive cervical cancer in patients with HPV16-positive, PD-L1-positive, recurrent and metastatic cervical cancer.
We concluded the enrollment of the 6 mg cohort in the VB-C-03 trial in patients with first-line head and neck cancer. We presented new preclinical data from our collaboration with Genentech, focusing on the differentiation of our proprietary vaccine technology. And we announced today the clinical collaboration with MSD to evaluate VB10.16 in combination with Keytruda in patients with HPV16-positive, high-risk, locally advanced cervical cancer. Before I hand over the word to Klaus, just want to remind you all of our pipeline, which is building up and expanding, showing, being a testament to our technology's breadth and flexible modality. Now building a long range of projects addressing a high number of patient groups with a significant unmet need and a large commercial potential.
In particular, I want to draw your attention to VB10.16, our wholly owned lead assets, for which we've now further expanded the scope with the VB-C-04 trial that was initiated, and of course, progressing the planning for VB-C-05. And Klaus will tell you more about these projects here. Also, again, drawing the attention to VB10.NEO, our individualized program that we're running together with Genentech and Roche. And later, we'll tell you a little bit of update on some of the interesting data we presented here. And of course, on the autoimmune disease area, where we're also continuing to progress establishing a solid proof of concept for what we think will be a first-in-class and best-in-class autoimmune disease approach to treat also a very large group of patients with an unmet need.
With those words, I'll hand over to you, Klaus. Take us-
Thank you, Michael. Good morning, good afternoon. As Michael told you, so one of the highlights of the Q1 was that we released a qualitative statement that our trial, VB-C-02, at what is the final analysis, meaning the analysis conducted when all patients had at least been observed for 24 months after last vaccination, in comparison to the data that we released in 2023, in the spring there, that was with 12 months follow-up on all patients after last vaccination.
The reason we issued it as a qualitative statement, stating that we closely mirrored the result we saw at the interim analysis, was that we, at this stage, find it very important that we can publish that data in the scientific literature, and most of the highly prestigious journals for that would not accept that you have released any quantitative data ahead of a potential publication. But obviously, closely mirror means closely mirror. And just to remind you, as also depicted on the slide, that in the relevant PD-L1 positive patient population in VB-C-02, we did see an overall response rate of 29%. We did see a median PFS of 6.3 months, and from the median overall survival at the time of analysis for the interim analysis, it was not reached, but it was at that time, 25 months.
That's obviously as depicted also on the slide, without going into too many details on it today, setting VB-C-02 out in a very favorable fashion to what you will directly compare with, which would obviously be monotherapy checkpoint inhibitor, whether that is atezolizumab, whether it's pembrolizumab, or whether it is cemiplimab. You can see the numbers as well as I can see them, but what clearly is depicted here is that the VB-C-02 was an add-on design, meaning that you added the vaccine on top of checkpoint inhibitor monotherapy or atezolizumab specific. And obviously, with the results that you are obtaining, both on a response rate but also on duration endpoint, you can say that you have shown that there is a vaccination effect without obviously having proven it, because it is a single arm trial. But I think it is important to then link that-...
To the information that Michael alluded to as a post-period highlight, that we this morning announced the continued clinical collaboration with Merck MSD for our next step in cervical cancer. And if you go to the next slide, Michael. Thank you. We have prior guided that we would on the basis of the VB-C-02 result move one step up in the treatment paradigm in cervical cancer, moving it into locally advanced in an adjuvant setting. We have also earlier said that it was important for us to get the results of the KEYNOTE-A18 data before we could plan for that trial.
As you all know, those data were released last year, and we have then obviously planned together with Merck MSD the design for subsequent VB-C-05 trial in exactly the same setting as KEYNOTE-A18 was conducted. We have not, at this stage, guided the exact initiation time point, kept it to 2025. But as you can allude, an uptake as a message here, that we would obviously not have entered into a supply agreement with Merck MSD without having firm plans of getting this trial initiated as fast as it is possible. I am just reminding you on what is also depicted on the slide shown, that the VB-C-04 trial, as Michael also alluded to, has now been initiated.
We expect to be on track with having the patients recruited by end of this year. We will meet a six-month follow-up on all patients or, meaning that if last patient will be recruited end of this year, we will be in a position to do the interim analysis for the VB-C-04 trial in recurrent metastatic cervical cancer, summer 2025. That will drive the decision, whether we have an accelerated path for a potential registration with FDA as soon as we have the availability of those results. I'll also just put a few words on the VB-C-03 trial, the recurrent metastatic head and neck cancer trial.
We are now at the last dose level, 9 mg in the dose escalation part of the trial, and will imminently be in a position to decide what the expansion part of the trial should be. Meaning, what are the doses that will be compared in the head and neck cancer setting, recurrent metastatic. As you all know, this trial is aiming of giving us a possibility to position also VB10.16 in recurrent metastatic head and neck cancer, but in the first line setting and not in the second line setting, as we are doing in cervical cancer.
So good to say progress on all elements, and obviously, based on the VB-C-02 data and the magnitude of the VB-C-02 data, we are very much looking forward to get further into the treatment paradigm in locally advanced cervical cancer. And by that, I will hand it over to Agnete.
Thank you, Klaus. So then we move forward to VB10.NEO, which is our fully individualized cancer neoantigen immunotherapy. And we've shown before that we have some inherent strengths and the key differentiators when we work with fully individualized cancer vaccines compared to other players out there. One is importantly, the solid manufacturing chain, plasmid DNA manufacturing, has also been shown to be a robust supply chain, but also can have some very interesting benefits when it comes to cost of goods and the turnaround time. We also see in the currently ongoing clinical trials and also completed N-of-one trial, we see a nice safety profile with our vaccines. We see a broad and strong T-cell response. So we do believe we have some competitive angles for our individualized cancer vaccines.
And that includes then, obviously, that we have a strong partnership with Genentech, Roche, to push this forward. And if you go to the next slide, the collaboration with Genentech is progressing nicely. And in addition to the collaboration on the clinical development of our individualized VB10.NEO vaccine, we continue to learn a lot about the features of our platform through the collaboration with Genentech. So this quarter, we were able to show some interesting preclinical data again, supporting that Nykode's APC-targeted DNA vaccine induces a broader and stronger T-cell response than peptide-based vaccines, including the exact same neoantigens. Here, also with peptide, with an adjuvant, and also in addition, with an anti-CD40 antibody.
To the right from this figure, interestingly here, when we also understand more about how to dose both in preclinical studies and in the clinical studies, we see an importance of the vaccination interval. Here comparing giving our vaccine with weekly compared to tri-weekly intervals. We do in the clinical trials today start with an induction phase that is tri-weekly, which is supported by this data. If you go to the next slide, we have also now together with Genentech, in Genentech's lab, been looking in detail into what the CD8 T cells that are elicited in response to our individualized cancer vaccine actually look like.
And even though we with here three different vaccine formats have vaccinated mice with the identical neoantigens, we see that the CD8 T cells that are generated in response to these vaccines are vastly different. We see that the VB10.NEO here, where you see the yellow dots, indicates high expression of some of these effector molecules that we can characterize in detail on the CD8 T cells. And as you see here, we believe that this T cell profile that we've seen here is supporting a differentiation towards more effector, effector memory phenotypes that should promote a stronger, more effective immune response. So we are very happy to understand more about the platform and to the quality of the CD8 T cells that we are generating.
Again, here, a difference when we compare different vaccination regimens, which gives us a nice tool to further support the platform and to deploy it as effectively as possible moving forward. Go to the next slide. So, today, we can say that VB10.NEO is able to induce a broad CD8 dominating T cell response, and we see that as pDNA, both in preclinical studies as well in the clinical studies, and recently also shown that in the mRNA vaccine format, where we also say updated that we will provide further data on our mRNA-based vaccines later this quarter. Go to the next slide.
So as we move to our autoimmunity platform to date, we moved into this, feeling that it was a very nice platform fit for us to take advantage of where we are with our APC-targeted platform, and move that into induction of tolerogenic immune responses to specific antigens. So that's a new treatment potential modality for autoimmune diseases, potential also for allergies, potential for organ transplantation, if we are able to skew the immune response in an antigen-specific manner from an unwanted immune response to a tolerogenic immune response. We can go to the next. And so, you...
If you have seen the mechanism of action of our cancer vaccine, you will see that we do take advantage of the platform as a totality, but we make obviously some changes when we want to induce a tolerogenic response that is antigen-specific compared to a stimulatory response that we do with our cancer vaccine. So we change the targeting unit so that our vaccine molecules will bind to different subsets of antigen-presenting cells, can be tolerogenic antigen-presenting cells, and these molecules will be internalized and presented to regulatory CD4 regulatory T cells, which can then have a benefit in order to modulate effector B cells, T cells in different manners.
If you go to the next slide, earlier in March this year, we were very happy to present further details on the APC-targeted contribution in a disease model. This is an EAE model, which is a preclinical model that mimics the multiple sclerosis disease. If you compare the black lines and the purple lines on these figures, you can see that mice treated with a fully functional Nykode vaccine that has the appropriate targeting unit provides a much better disease-modulating response than the exact same vaccine with a non-functional targeting unit. It really shows the contribution of the targeting unit in the ability to affect the disease in this model system. Next, we go to the next slide.
We have then also looked into the contribution and whether this is actually antigen-specific. So if we incorporate an irrelevant antigen instead of the disease specific antigen here in green, if we see no response if we are using a irrelevant antigen. So we can see that both the targeting unit and the antigenic unit is important to generate the optimal response. So a very nice data supporting the three modular structures that we are working with here at Nykode. We go to the next slide. And I don't see the next slide. Yeah. Then we see that all the data we have presented before was done in a prophylactic setting, so we were treating the mice before onset of disease.
We're very happy to see that we could also see the same efficacy, actually, when we started to treat practically at the same time point that we started to see the disease symptoms in this model, which will be important obviously in the clinical setting as well. Then we go to the next slide. These were all data done with the multiple sclerosis model, and here just to repeat earlier data we presented in J P Morgan in first quarter. In January, we have data in the diabetes model, where we use the plasmid DNA format of our vaccine. The targeted version provides also here a benefit in the disease model for type 1 diabetes.
Interestingly enough, if we add our second generation technology, where the DNA plasmid also secretes three additional fourth module cytokines, we actually did not see any sign of disease in any of these mice until we withdrew treatment. And then also after withdrawing treatment, we could see a long-lasting effect in what groups. Next slide. In totality, we have reached a stage where we have a lot of supportive data for the APC-targeted format, both in the diabetes model and EAE model, and also additional data supporting the contribution of our second generation fourth module technology. We have now reached a different stage on this platform, and are looking forward to further update you also actually later this quarter with even more data from our programs.
And then I hand over to our CFO, Harald.
Thank you, Agnete. Looking at the income statement, we reported total revenue of NOK 1 million in the first quarter, of which NOK 800,000 relates to R&D activities delivered under the agreements with Genentech and Regeneron. Employee benefit expenses were NOK 8.8 million in the first quarter, up from the NOK 6.7 million for the same period in 2023, reflecting the growth in the organization. Finance income was two point two million, which mainly relates to interest income, while finance costs of NOK 3.1 million mainly relate to unrealized currency losses on a NOK 1 million exposure. So overall, we recorded a net loss of NOK 14.9 million for the first quarter.
Then moving on to the balance sheet, we had a strong cash position of NOK 147.3 million at the end of the quarter, meaning we are well positioned to execute our strategy. As previously communicated, we received a decision from the Norwegian tax authorities in the fourth quarter of 2023, where they reiterated their position that are from payments received under a license agreement entering into 2020, should be recognized as taxable income in full in 2020, rather than the use of taxable gain loss account, where a part of the taxable income will be deferred to subsequent years based on a 20% decline. The decision generated a payable of approximately NOK 30 million in the fourth quarter of 2023.
Nykode is confident that the use of taxable gain loss account is the correct treatment of the upfront payment, a view which has also been confirmed by third-party tax experts. Nykode has appealed the decision, and the payment has been booked as a receivable while we await the outcome of the appeal. Next, please. Moving on to equity and liabilities, we have total equity of NOK 159 million, which represents a strong equity ratio of 83%. And with that, I will give the word back to Michael.
Thank you very much, Harald. As you can all appreciate, it's been an eventful quarter, first quarter of the year, with all important data or conclusions announced from our VB-C-02 trial, as well as progress on our other trials. Good progress on our autoimmune disease platform, our collaboration with Genentech, as well as the mRNA modality also. We are pushing hard with a high sense of urgency to further progress our assets. We will work very hard to finalize the enrollment for the first part of the VB-C-02 trial, which will put us in a position, as Klaus said, to decide which doses we'll push forward into the second part of the VB-C-03 trial.
We plan to finalize enrollment for the part one, the randomized part of the VB-C-04 trial, within the year, and we also are looking forward to update you on progress of NYK011, our preclinical oncology program targeting colorectal cancer. Although we did already provide updates on the autoimmune disease platform, as Agnete mentioned, we are planning to further update you within this first half of 2024, so in second quarter. And we also plan to provide further updates on our mRNA modality in this second quarter. So looking forward to keep you updated on the progress, both of our technology platform as well as our clinical assets. And with those words, we are ready to open up for questions. Daryl, if you'll take us through.
Thank you. We will now be conducting a question and answer session. If you would like to ask a question, please refer to the Ask a Question text box on your webcast player. Simply type in your question and click Send to submit. One moment, please, while we poll for your question. All right, our first question are coming from Alexander Krämer with ABG Sundal Collier. Question one, on cervical cancer, your expert speaker at your last CMD, Brad Monk, will have a presentation about immunotherapy and cervical cancer at the upcoming ESMO gynecological cancers. Do you expect this to have a positive impact on awareness about your cervical program? Do you believe it could spark the C-04 trial to speed in trial site startup?
Klaus Edvardsen here. Let me just for the audience, Brad Monk is the vice president of the GOG Foundation in the United States. I obviously do not know what Brad intends to present at ESMO Gynecology, but it can certainly not harm us, but I cannot answer whether it benefits us. I would not reckon that Brad would talk about the VB-C-04 trial because this trial is, as we alluded to, just initiated, and it would be more interesting to talk on that trial when we will have the results. But let me address the question in a different manner.
There was obviously a reason for us engaging with the Gynecologic Oncology Group, and thereby also Brad Monk, because they are the ones that are setting the treatment paradigm for how you treat, among others, cervical cancer in the United States. As we have told you a number of times, we are confident on our vaccine concept in HPV-driven cervical cancer, by engaging with the Gynecologic Oncology Group. We also believe that that is a firm validation by that group of the scientific question that we are asking, and by that would certainly benefit the recruitment and interpretation of the eventual trial results.
Thank you. The follow-up, question two on head and neck VB-C-03 trial. Could you share your view on how you see future opportunities in head and neck cancer evolving beyond the VB-C-03 patient population, considering also the background of lessons learned from Tecentriq's IMvoke010 trial disappointment recently?
Yeah, as I said, when I gave the update, the VB-C-03 trial in head and neck cancer is in the first line, recurrent metastatic head and neck cancer setting. And when we have done the dose finding part that we are currently conducting, we would eventually then be in a position to decide whether we would seek a trial in first line recurrent metastatic head and neck cancer. That would all be dependent on the outcome of VB-C-03. But although you cannot directly say that an HPV-driven head and neck cancer is the same as an HPV-driven cervical cancer, but intuitively, you would like to believe that the mode of action for the vaccine would obviously give you similar effects, irrespectively of indication.
But that will have to be proven, and that will be decided at the time point where we see the outcome of VB-C-03. But VB-C-03 will give us, as I said, the option to go into first line recurrent head and neck cancer, and that's the plan. We have also earlier guided without any specificity on timing, that one could also consider locally advanced in head and neck cancer. It is very correct that the data from the IMvoke010 trial, which is testing atezolizumab or Tecentriq out in a strict adjuvant setting in locally advanced head and neck cancer, read out negative, which was not expected, but that is what happens in research.
Does not immediately impact our plans, because as I said, we have not been specifying any exact timing for going in, into that setting. And you could also turn it around and say that, an add-on design in a strictly adjuvant setting, and what do I mean by that is that in essence, IMvoke010 was given definitive treatment. There was a washout period, and then you were randomized to either atezolizumab or watch and wait. You could obviously also envision a trial design that would be trying to capture also the more concurrent phase of the treatment, like we are doing in cervical cancer.
So one should not disregard that the vaccine could also play a role in locally advanced head and neck cancer, and you could even envision an add-on design to atezolizumab, where the vaccine potentially could give that effect that atezo by itself could not manage. Let me make it very clear that it's not an atezo issue as such, because none of the other checkpoint inhibitors have actually shown any benefit of adding that to the definitive treatment in head and neck cancer, but should not prelude us for speculating about whether the vaccine could do that last part of it.
... Thank you. And the third question from Alexander is on autoimmunity platform. In your next autoimmunity update, are you going to show data on later therapeutic delivery at disease peak severity, or is it more focused on characterization of the mechanism of action?
Thanks, Alexander. First of all, it's a pleasure to interact with an analyst that has so much expertise and interest in the field of autoimmunity and inverse vaccines. When it comes to the exact answer to your question, I think you will have to wait another month or so in order to get the exact answer.
Thank you. Our next questions are coming from Geir Hiller Holom with DNB Markets. Question one is, could you please elaborate around how you envision the timeline for your planned VB-C-05 trial in adjuvant setting, and how many patients you plan to include in the trial?
Yeah, it's Klaus here again. Hi, Geir. We have not been guiding on any exact time point for initiation. As I also said in my introduction to the highlights of this quarter, that a specific timeline will not be guided today, but the trial will be initiated in 2025, and we will guide at the time when we have a firm understanding on what those timelines will be. To the question on the number of patients in there, that it will be in the range of a definitive phase II program, which would be at the ballpark of 180 patients -200 patients.
Thank you. The follow-up question is, could you please elaborate on when you envision NYK011 entering the clinical stage?
I think it's too early to say exactly a time point for when, the NYK011, for the ones that do not really know what NYK011 means, that is, the program that we guided on December last year, that is trying to look into, colorectal polyps or colon polyps, I should rather say. That is a continuum for spontaneous polyps that are benign in nature. Some of them turn into being malignant. We are trying in this program to look into can we actually capture the full continuum of, spontaneous polyps, and all the way up to something that would look more like a full-blown malignant colorectal cancer.
What we said was that we were going to guide in the second half of this year on what concepts would we bring in to beginning of preclinical development, with the aim of ending up with a clinical development path. And what do I mean by that? There are two options here. You can either go spontaneous polyps, or you can look into more familiar genetic-driven polyps. The benefit of going into what's called FAP, Familial Adenomatous Polyposis, is that there is a much higher likelihood that those polyps will turn into malignancy, and therefore, the trial concept would likely be easier to conduct. But those decisions will all be dependent on the quality of the constructs that we are currently working on.
So you will have to wait for the final clinical timeline guidance, until we will have selected the construct for one or the two indications.
Thank you. Our next questions are coming from Patrick Trucchio with H.C. Wainwright. Patrick wrote: On 29th April , the FDA granted traditional approval to Tivdak for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. This innovaTV 301, uh, sorry, I don't know how to pronounce that. Tivdak previously received accelerated approval for this indication. First, can you discuss any read-through from this program to the VB10.16 program? And secondly, is there a scenario under which Nykode may seek accelerated approval for VB10.16? And lastly, what data would support accelerated path to approval for VB10.16?
Let's start from the bottom. The Tivdak data, innovaTV 301, is the trial that confirms the Tivdak accelerated approval as the second-line treatment option in recurrent metastatic cervical cancer. It came out with median overall survival in the Tivdak arm of 11.5 months, compared to chemotherapy alone, which ended at 9.5 months. They also did look at a secondary endpoint on response rate, which came out as 18% in the Tivdak arm, compared to 5% in the chemotherapy arm.
On the basis of that, as you can likely see here, it is a relatively low-hanging fruit to beat chemotherapy in that setting, with a response rate of 5% and a median overall survival of 9.5 months. I'm not by that saying that Tivdak is not relevant, but it will address kind of the data that we would need to be capable of also achieving in our VB-C-04 trial. To the question about whether the accelerated approval for Tivdak that turned into now a full approval, I think it is important to bear in mind that the label or prescribing information that FDA gave Seagen and Genmab for Tivdak is specifying not exactly the same patient population as we are doing in the VB-C-04 trial.
The Tivdak label reads that you need to have been, or you have the potential to be treated with Tivdak if you have been treated with no more than two prior therapies, and that one of those therapies needs to be platinum-doublet chemotherapy. The patient population that we are in, with VB-C-04 is strictly patients that fail standard of care, first-line cervical cancer, pembrolizumab ± chemotherapy ± bevacizumab or Avastin. Plus, we have a biomarker-defined patient population as we are only treating patients that are HPV-16 positive. So I think we have, an opening with FDA. Of course, all dependent, as we have also guided earlier, that the results will have to be a magnitude that I alluded to when I gave the Tivdak results, or potentially, especially on the duration part of the endpoint.
We know from VB-C-02 that we can achieve significant prolongation of the duration endpoint by adding the vaccine. So in Nykode's view, the label that Tivdak ended up with has not put any higher barrier into us going to FDA in sometime 2025, with the interim analysis of VB-C-04, and have a discussion on a potential accelerated path. It will totally depend on the magnitude of the results that we are seeing at that time point.
Thank you. Our next question is coming from Lucy Codrington with Jefferies. Lucy wrote, "For the newly announced work collaboration for VB-C-05, how involved will Merck be, or is it just a supply agreement?
This is a supply agreement, but also a clinical collaboration in the sense that we have been in close interaction with Merck in the design and the expected outcome of that trial, which has obviously been in our interest because we have then learned more significant information experience out of the KEYNOTE-A18 trial. But certainly also in Merck's interest because as it's very obvious, based on KEYNOTE-A18, there's still room for improvement adding even more treatment modalities on top of a checkpoint inhibitor. But in strict terms, it is a supply agreement.
Thank you. Our next questions are coming from Sebastian van der Schoot with Van Lanschot Kempen, said, "Thank you for taking my questions first off, and for the adjuvant setting and cervical cancer, can you provide some insight on how your current thinking is on constructing the protocol? Will it be randomized?
Yes, it will be randomized. We have not yet been telling the exact design, but the parameters that you can test out here is you can obviously add the vaccine VB10.16 on top of pembrolizumab to the chemoradiation that used to be standard of care. That's called the concurrent setting. That's one option. You can also follow in a more adjuvant maintenance type setting, where you, after that chemoradiation, plus pembrolizumab, plus vaccine, is following up with pembrolizumab and the vaccine for a period. That could be for one year, it could be for two years. That you will see when we release the final design.
Then the last thing that you could also add in here would be a concept that is getting more and more tailwind, and that is having an induction phase, or if you like, a neoadjuvant part. You have likely seen that that's an approach that's been utilized recently by nivolumab in non-small cell lung cancer in a locally advanced setting, indicating that that is giving a better benefit total outcome for patients. So all of those questions are currently being assessed and discussed, and in due time, we will obviously release the final design. I cannot give you a time for that today, but it will be imminently.
Thank you. The follow-up from Sebastian is: Can you provide some insight on what the data readout for HNSCC will look like in terms of the number of patients and amount of follow-up by YE?
I'm not sure that I fully understand the... Is that a question related to the VB-C-03 trial? Then, as I said, there is a dose escalation phase that is testing out 3 mg, 6 mg, and 9 mg with three patients on each of those dose level. When that has been cleared, it will move into the expansion phase, where the decision will be, would the comparator in that trial be 3 mg towards 6 mg, 3 mg towards 9 mg? And that will then drive when the trial read out what is the final recommended dose. So right now, obviously, as I said, we have opened up now for the possibility of including the last three patients in the 9-mg cohort.
When that is done, we can move in to the expansion phase, which it will total around 40 patients. If that's the question, then that's the numbers.
Thank you. As a reminder, if you would like to ask a question, please refer to the Ask a Question text box on your webcast player. Our next questions are coming from the line of Kristin Nyberg with Starship AS. And Kristin wrote: If possible, could you comment on cash flow and your estimates with a base case scenario? Do you see the need for more capital over the coming years? And once again, thank you, for your presentation, Kristin said.
Yeah, thank you. You know, we are well capitalized, and our guiding has been that the, the runway, based on our current commitment, extends into 2026. That's not taking into account the, the NOK 30 million tax issue, which, of course, we are confident that we, we, we will win the appeal. It's also on the other side of the important interim data from the VB-C-04 trial, which we, of course, could seek a partner. No, we do not have any specific plans for, to raise any additional capital at the current time.
Thank you. So there are no further questions at this time. I'd now like to hand the call back over to Michael Engsig for closing comments.
Thanks a lot, Daryl. Thanks to the entire team here, and, thanks to all the participants for dialing in and for your engaged questions. Looking forward to keep, you, all of you updated on our continued progress in the future. Have a good day.
Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect at this time. Enjoy the rest of your day.