Nykode Therapeutics ASA

OSE:NYKD

Earnings Call Transcript 2024-Q1

[Operator]

Greetings, and welcome to the Nykode Therapeutics Q1 2024 Financial Results Presentation. [Operator Instructions] 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.

[Michael Engsig, executive]

Thank you very much, Darryl, and to all the participants. A very warm welcome to this Q1 report. We assume you're all familiar with our forward-looking statements. And on that note, we'll move forward. I am very pleased to have with me here today are Agnete Fredriksen, our Chief Scientific Officer, Head of Business Development and Co-Founder. 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 benefit and indicating a synergistic treatment effect of VB10.16 in combination with atezolizumab. We also announced the advances in our inverse vaccine platform with the 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 withdrawal. 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, metastatic cervical cancer. We concluded the enrollment of the 6-milligram 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 chemical 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, I just want to remind you all of our pipeline, which is building up and expanding showing -- being a testament to our technologies 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'll now further expanded the scope with the C-04 trial that was initiated and of course, progressing the planning for 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 are running together with Genentech, Roche. Agnete will give you a little bit of update on some of the interesting data we presented here.

And of course, on the alternative 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. Treat also a very large group of patients with an unmet need. With those words, I'll hand over to you Klaus.

[Klaus Edvardsen, executive]

Thank you, Michael, good morning, good afternoon. as Michael told you, one of the highlights of the Q1 was that we released a qualitative statement that our trial C-02 at what is the final analysis, meaning the analysis conducted when all patients have at least being 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 the last vaccination. The reason we issued it as a qualitative statement stating that we closely mirrored the results we saw at the interim analysis. Was that we, at this stage, find it's very important that we can publish that data in the scientific literature. And most of the highly prestigious journal for that would not accept that you have released any quantitative data ahead of a potential publication.

But obviously, closely mirrored means closely mirrored, and just to remind you, as also depicted on the slide, that in the relevant PD-L1 positive patient population in C-02, we did see an overall response rate of 29%. We did see a medium PFS of 6.3 months. And from the medium 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 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 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 deep results that you're 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's important to then link that to the information that Michael alluded to as a post-period highlights. 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 C-02 results 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 the subsequent 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 all 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 C-04 trial, as Michael also alluded to has now been initiated. We expect to be on track with having patients recruited by end of this year. We will meet a 6-month follow-up on all patients and 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 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 C-03 trial, the recurrent metastatic head and neck cancer trial. We are now at the last dose level, 9-milligram 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 possibility to position also VB10.16 in recurrent metastatic head and neck cancer, but in the first-line setting and not in the second it setting as we are doing in cervical cancer.

So good to say, progress on all elements. And obviously, based on the C-02 data and the magnitude of the 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.

[Agnete Fredriksen, executive]

Thank you, Klaus. So then we move forward to VB10.NEO, which is our fully individualized cancer [ in the oxygen ] immunotherapy. And we've shown before. But 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 and also shown to be robust supply chain when all that 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-01 trial. We see a nice safety profile with our vaccines with 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 a Genentech, Roche to push it 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 vaccines, including the exact same neoantigens, here also with peptide with adjuvant and also in addition with the 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 install here comparing giving our vaccine [ mid ] weekly compared to triweekly interval. We do in the clinical trials today and start with an induction phase, but it's triweekly, which is supported by these data.

If you go to the next slide, we have also now together with Genentech, Internet tech 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 would hear 3 different vaccine formats, have vaccinated mice with the identical neoantigens, we see that the CD8 T cells that are generated in response to this vaccine are basically different. We see that VB10.NEO here where you see the yellow but indicate high expression of some of these effector molecules that we can characterize indeed 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. [ chemokines ] that should promote a stronger and 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 regimen, which gives us a nice tool to further support the platform and to employ us effectively as possible moving forward. Go to the next slide. So today, we can say that VB10.NEO is able to use a broad and CD8 dominating T cell response. And we see that at pDNA both in preclinical studies as well as the clinical studies and recently also shown in the mRNA vaccine format where we also updated that we will provide further data on our mRNA-based vaccine later this quarter. Next slide. So if we move to our Autoimmunity platform to date, we move 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, potentially 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 tolerogenic response that is antigen specific compared to a simulator response that we do it in power with our cancer vaccine. So we changed the targeting units so that our vaccine molecule 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 Treg regulatory T cells which can then have a benefit in order to modulate effector B Cells or T cells in different manners.

If you go to the next slide, the earlier in March this year, we -- we're very happy to present further details on the APC targeted contribution in the disease models. And this is an EAE model, which is preclinical model that mimics the multiple sclerosis disease. And if you compare the black clients and the purple lines on these figures, you can see that mice treated with a fully functional Nykode vaccine and has the appropriate targeting unit provides so much better disease modulating response then the exact same vaccine with a nonfunctional targeting unit.

So it really shows the contribution of the targeting unit in the ability to affect here disease in this model system. If we go to the next slide. We have then also looked into the contribution and whether this is actually antigen-specific. So we fully incorporate in relevant antigen instead of the disease-specific antigen here, in green, it's -- we've seen no response if we are in using 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 3 modular structures that we are working with here at Nykode. If we go to the next slide. 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 symptoms in this model, which will be important, obviously, in the clinical setting as well.

Then we go to the next slide. And these were all data done with the multiple sclerosis model. And here, just to repeat earlier the data we presented in [indiscernible] in first quarter. In January, we have data in diabetes model, where we use DNA format of our vaccine targeted cell version provides also here a benefit in the disease model for type 1 diabetes and interestingly enough, as we add our second-generation technology. Where the DNA plasmid also secretes 3 additional 4th module. Cytokines, we actually did not see any sign of receiving any of these mice until we withdraw [ liter ] treatment. And then also after withdrawing treatment, we could see a long-lasting effect in what good.

Next slide. So in totality, we have reached a stage where we have a lot of supportive data for the SEC targeted format, both in the diabetes model and EAE model also additional data supporting the contribution of our second-generation 4th module technology. And so 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.

[Harald Gurvin, executive]

Thank you, Agnete. Looking at the income statement. We reported total revenue of $1 million in the first quarter of which $800,000 related to R&D activities delivered under the agreement with Genentech and Regeneron. Employee benefit expenses were $8.8 million in the first quarter up from $6.7 million for the same period in 2023, protecting the growth in the organization. Finance income was $2.2 million, which mainly relates to interest income, while finance costs of $3.1 million mainly related to unrealized currency losses on Norwegian [ craft ] exposure. So overall, we recorded a net loss of $14.9 million for the first quarter. Then moving on to the balance sheet. We had a strong cash position of $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 decision other from payments received under a license agreement entered into in 2020, should we recognize a taxable income in full in 2020 rather than the use of taxable gain of account whatever part of the taxable income will be deferred to subsequent years based on a 20% decline on guidance. The decision generated a table of approximately $30 million in the fourth quarter of 2023. Nykode is confident that the use of taxable gain of account is the correct treatment of upfront payment, a view which has also been confirmed by third-party tax experts.

Nykode has appealed to the decision and the payment has been booked as a receivable while we await outcome of appeal. Moving on to equity and liabilities. We had total equity of $159 million, which represents a strong equity ratio of 83%. And with that, I will give the word back to Michael.

[Michael Engsig, executive]

Thank you very much, Harald. And as you can all appreciate, it's been an eventful quarter, first start of the year with all important data or conclusions announced from our 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. But 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 C-02 trial, which will put us in a position, as Klaus said, to decide which doses will push forward into the second part of the C-03 trial. We plan to finalize enrollment for the Part 1, the randomized part of the C0-4 trial within the year.

Although -- sorry, and we also are looking forward to update you on the 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. Darryl, if you will take us through.

[Operator]

[Operator Instructions] Our first question coming from Alexander Kramer 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 Gynaecological 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, the speed in trial site start-up?

[Klaus Edvardsen, executive]

Last efforts in here, let me just for the audience, Brad Malt is the Vice President of the Gynecological Oncology Group 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 will talk about the 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. That was obviously a reason for us engaging with the Gynecological 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.

And 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 Gynecological 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.

[Operator]

And the follow-up. Question 2 on head and neck C-03 trial. Could you share your view on how you see future opportunities in head and neck cancer evolving beyond the C-03 patient population? Considering also the background of lessons learned from Tecentriq IMvoke010 trial disappointment recently.

[Klaus Edvardsen, executive]

Yes. As I said when I gave the update, the 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 C-03. But although you cannot directly say that HPV-driven head and neck cancer is the same as in 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 both be decided at the time point where we see the outcome of C-03. But 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 ceramic cancer readout 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 into that setting. And you could also turn it around and say that an add-on design in a strictly adjuvant setting and what going -- I mean by that is that, in essence, IMvoke010 was given definitive treatment. There was a rash out 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 ad on design to atezolizumab, 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 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.

[Operator]

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 mechanism of action?

[Agnete Fredriksen, executive]

Thanks, Alexander. First of all, it's a pleasure to interact with an analyst that has so much expertise and interest in the silo post immunity 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 exact.

[Operator]

Our next questions are coming from Geir Holom with DNB Markets.

Question one is, could you please elaborate around how you envision the time line for your planned C-05 trial in adjuvant setting and how many patients you plan to include in the trial?

[Klaus Edvardsen, executive]

It's Klaus here again, Geir. We have not been guiding on any exact time point for initiation. And as I also said in my introduction to the highlights of this quarter that a specific time line 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 time lines will be. To the question on the number of patients in there, that will be in the range of a definitive Phase II program, which would be at the ballpark of 180 to 200 patients.

[Operator]

And the follow-up question is, could you please elaborate on when you envision NYK011 entering the clinical stage?

[Klaus Edvardsen, executive]

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. And that is a continuum for spontaneous polyps that are benign in nature. Some of them turn into the malignant and 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 through beginning of preclinical development with the aim of ending up with a clinical development path.

And what do I mean by that? There are 2 options here. You can either go spontaneous polyps or you can look into more family genetic-driven polyps, the benefit of going into what's called FAP, family adeno polyposis, is that there is a much higher likelihood that those products 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 time line guidance until we will have selected the construct for 1 of the 2 indications.

[Operator]

Our next questions are coming from Patrick Trucchio with H.C. Wainwright.

On April 29, the FDA granted traditional approval to TIVDAK for recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Tisotumab , 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?

[Klaus Edvardsen, executive]

Let's start from the bottom. The TIVDAK data, [ INNOVAF01 ] is the trial that confirms the TIVDAK accelerated approval as the second line treatment option in recurrent metastatic cervical cancer came out with media mobile survival in the TIVDAK arm of 11.5 months compared to chemotherapy alone, which ended at 9.5 months. They also did look as a secondary endpoint on response rate, which came out as 18% in the TIVDAK arm compared to 5% in the chemo therapy arm. On the basis of that, as you can likely see -- it is a relatively low hanging fruit to beat chemotherapy in that setting with a response rate of 5% and a medium 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 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 of prescribing information that FDA gave CM genetics and generic is specifying not exactly the same patient population as we are doing in the C-04 trial. The TIVDAK tag label reads that we need to be -- or you have the potential to be treated with TIVDAK if you have been treated with no more than 2 prior therapies and that one of those therapies needs to be [ do with ] chemotherapy. The patient population that Lear in with C-04 is strictly patients that fail standard of care first-line cervical cancer, pembrolizumab plus [ minus ] plus chemotherapy plus minus bevacizumab or Avastin plus we have a biomarker defined patient population as we are only treating patients that are HPV16-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 and we know from C-02 that we can achieve significant prolongation of 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 somewhat 2025 with the interim analysis of 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.

[Operator]

Our next question is coming from Lucy Codrington with Jefferies.

Lucy wrote for the newly announced [indiscernible] -- how involved will Merck be? Or is it just a supply agreement?

[Klaus Edvardsen, executive]

This is a supply agreements, 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 a more significant information experience out of the KEYNOTE-A18 trial. But certainly, also in Merck's interest, because it's very obvious based on KEYNOTE-A18, there's still room for improvement, adding even more treatment modalities on top of the checkpoint inhibitor. But in strict terms, it is a supply agreement.

[Operator]

Our next questions are coming from Sebastiaan van der Schoot with Van Lanschot Kempen.

And for the adjuvant setting in cervical cancer, can you provide some insight on how your current thinking is on constructing the protocol? Will it be randomized?

[Klaus Edvardsen, executive]

Yes, it will be randomized, and 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 chemo radiation 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 1 year, it could be for 2 years. That though you will see when we release the final design. And then the last thing that you could also add in here be a concept that is getting more and more headwinds, and that is having an induction phase or if you like, a new adjuvant part. You have likely seen that that's an approach that's being 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 to date, but it will be imminently.

[Operator]

And the follow-up from [indiscernible].

Can you provide some insight on what the data readout for HNSBC will look like in terms of the number of patients and amounts of follow-up by Ye?

[Klaus Edvardsen, executive]

I'm not sure that I fully understand that -- is that a question related to the C-03 trial. Then, as I said, there is a dose escalation phase that is testing out 3 milligrams, 6-milligram and 9-milligram with 3 patients in each of those dose levels. And that has been cleared. It will move into the expansion phase where the decision will be with the comparator in that trial be 3-milligram towards 6 milligram, 3-milligram towards 9 milligram, and that will then drive when the trial readout 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 3 patients in the 9-milligram cohort, when that is done, we can move into the expansion phase, which will total around 40 patients. If that's the question, then that's the numbers.

[Operator]

[Operator Instructions] Our next questions are coming from the line of Kristen Norsat with Starship AS.

And Kristen wrote, if possible, could you comment on cash flow and your estimates with the base case scenario, do you see the need for more capital over the coming years? And once again, thank you for your presentation.

[Harald Gurvin, executive]

Yes. Thank you. We are well capitalized, and our guiding has been that the runway based on our current commitment extends into 2026. That's not taking into account the $30 million tax issue, which, of course, we are confident that we will win the deal. Is also on the other side of the important interim data from the C-04 trial, which we, of course, could seek a partner. So we do not have any specific plans to raise any additional capital at the current time.

[Operator]

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.

[Michael Engsig, executive]

Thanks a lot, Darren. Thanks to the entire team here. And thanks to all the participants for dialing in and for your engaged questions. Looking forward to keep all of you updated on our continued progress in the future. Have a good day.

[Operator]

Thank you. This does conclude today's teleconference. We appreciate your participation. You may disconnect at this time. Enjoy the rest of your day.