Good morning, everybody, and welcome to our business update webcast. I appreciate the ones that are participating in this webcast and for your interest in all the developments around Ultimovacs these days. As usual, I'm here together with our Chief Medical Officer, Jens Bjørheim. And as usual, if you have any questions during the presentation, please send it to us, and we'll try to address these as many as possible at the end of the presentation. If we move to the next slide, I need to show you the disclaimer, as you know, we're a public listed company. So, let's move to the next slide and tell you a little bit of, you know, what is gonna be included in this presentation. I will start by giving you a brief company update.
Jens will then cover the UV1 phase II clinical program, and then I will come back at the end to talk about the way forward. So let's move to the company update. You know, you know, in the next slide that we presented the results from the INITIUM trial, you know, in March, and you know we were all very surprised and disappointed by these results in INITIUM. And the fact that the UV1 didn't show effect you know on top of ipilimumab and nivolumab, as you know, is the standard of care in these advanced melanoma patients. The analysis of the INITIUM data confirms this top-line results and showed no subgroup data of significant relevance, but Jens will cover this topic in more details.
On the other hand, in the NIPU trial, this time in advanced mesothelioma, UV1, on top of the same combination, ipilimumab and nivolumab, demonstrated a near doubling in the objective response rate and the meaningful survival benefits compared with the ipilimumab and nivolumab alone. However, the primary, the progression-free survival that was the endpoint, was not met based on the assessment by the Blinded Independent Central Review. You can see here that the combination, the immunotherapy combinations are the same in the two trials, but the disease characteristics are very different. You know, in, in melanoma, these are, newly diagnosed first-line patients. In melanoma, the NIPU study was in second-line, mesothelioma patients, and also the efficacy expected in these indications, totally different. As I mentioned, in melanoma, ipi/nivo is the standard of care. In second-line mesothelioma, it's not even approved.
So this is to show that, you know, even in with the same combination, you have to expect different results depending on the, the type of cancer, the biology, and the stage of the disease. But these results really underscore the importance of having a broad, data-driven clinical development program, particularly with randomized trials, as trial results are expected to differ across various cancer indications and combinations. If we move to the next slide, you know, this really substantiates and supports the decision taken by Ultimovacs, the management team, and the board years ago, to really have a development program that explores different cancer types and immunotherapy combinations to really investigate in a randomized control program, how and where UV1 can demonstrate a clinical improvement.
This program really has benefits from an extensive collaboration with the various academic research groups and is conducted at hospitals across the U.S., Europe, and Australia, and really supported by top-line medical experts and leading pharmaceutical companies. As I mentioned, you know, includes five different cancer indications and immunotherapy combinations, and these were strategically selected to really make a broad evaluation of UV1's potential. Each trial will bring valuable insights to assess UV1's efficacy in each of these individual indications. But of course, as you can see already for the results, you know, they really don't impact on other trials, because all these cancer types are very diverse, very different characteristics and combinations across the program.
We have, we have studies like NIPU and INITIUM, where we combine with ipi and nivo, and in the other studies, you know, we compare with monotherapy. If we move to the next slide, you know, this is just to emphasize really the importance of having this broad program. And again, I want to emphasize here that this is achieved with a very small team, but very dedicated. You know, if we would have a program with only assessing the impact of UV1 in melanoma, we will be in a very difficult situation at the moment. But we have this broad program that, of course, we will be discussing in more details.
So if we move to the next slide, I really want to emphasize in this slide that, you know, we remain confident in UV1's potential. Really, the team is strongly committed, and the board, to bringing Ultimovacs across the next important data points that are the readout from the FOCUS trial in the Q3 of this year, 2024, and the DOVACC results in the first half of 2025. Why is that? You know that we have had encouraging results from different phase I studies with UV1. In the NIPU trial, UV1 has demonstrated a clinically relevant benefit in really reducing the risk of death, and also having a significant impact in the objective response rate. The data from the NIPU trial received positive feedback, not only from the investigators, but also from regulatory authorities.
As you know, we received Fast Track Designation and Orphan Drug Designation. Also because we know that immunotherapies regularly fail in some indications, while succeeding in other ones. That's why it's industry standard, particularly in the big pharmaceutical companies, that when establishing a development program, you know, it's practice to evaluate the compounds in multiple indications simultaneously, particularly when you have a mechanism of action that has broad potential. We will continue so committed to really developing UV1 across these value inflection points, and simultaneously we continue activities supporting the preclinical and CMC development of the TET platform. These activities are ongoing, and we will provide an update during Q4 of this year, 2024. If we move to the next slide.
You know, with this goal of really taking the company across these value inflection points, with DOVACC coming in the first half of 2025, was important that we will be able to extend the financial runway past the readout of the DOVACC trial in 2024-2025. This, of course, requires operational adjustments. We had to adjust our activity level, prioritization of projects, and this will be implemented to really extend the financial runway. Unfortunately, these have to include a workforce reduction of approximately 40%. With this, reprioritization plans and workforce reduction, we are extending the financial runway to the fourth quarter of 2025, well behind the anticipated top-line readout for the phase II DOVACC trial.
Based on the current plans and forecasts, the cash burn rate is estimated to be approximately, by the end of this period, approximately NOK 15 million per quarter. Of course, all this is prior to initiation of potential new activities, of new clinical trials or projects. If we move to the next slide, you know, I give the word now to Jens, so he takes us through the clinical program and the reason why we remain confident in the potential of UV1. Jens?
Thank you, Carlos, and good morning to everybody. This part, as Carlos said, is about the clinical program, the phase II strategy, and the clinical trials in that stage. Going back to 2018, 2019 first, so at that time, we had three phase I trials that we have results from, and from those trials, we did see strong immune responses against telomerase. We know that we induce such immune responses. We also saw a synergy between checkpoint inhibitors and the UV1 vaccine, and further, also efficacy signals in all the trials, and with a beneficial safety profile. Based on this phase I findings, we decided to move the project into phase II.
In the phase II part of the program, we had different things that needs to be in place to be a relevant study to start for us. First of all, it's needed that the telomerase, our target for the T -cells we expand, is expressed in the indications where we do clinical trials. Also, we did all the phase II trials with different endpoints to capture UV1 efficacy and define the best path forward in future phase III trials. We wanted to combine with checkpoint inhibitors. We believe that there is a mutual dependency between the checkpoint inhibitors on one side and the immune system on the other side. Also, in the trials, we have been sampling both liquid and solid tissue to be able to characterize treatment efficacy moving forward. Moving on to the next slide.
So we have combined in our phase II trial with different checkpoint inhibitors. To the left, you can see, ipilimumab and nivolumab or anti-CTLA-4 and PD-1. That combination of CPIs are used in the INITIUM and NIPU trials. This combination of CPIs is regarded as the most effective, checkpoint inhibitor treatment in immunogenic tumors. Adding UV1 on top of this combination was seen as an opportunity to improve on the best-in-class CPIs. Also, mechanistically, ipilimumab or anti-CTLA-4, is hypothesized to generate stronger vaccine-induced T-cell responses for patients. On the other side, it's also important to mention that the combination is very toxic. For the three next phase II trials, the FOCUS trial, the DOVACC trial, and the LUNGVAC trial, we have combined with anti-PD-1 or anti-PD-L1. This is the most commonly used, checkpoint inhibitor with more than 35 indications.
The hypothesis, why should you add a vaccine on top of anti-PD-1 or anti-PD-L1, is that in patients there are patients that have few T-cells that is effective against the tumor. So in those patients, it's a rationale for adding new T-cells that can recognize antigens within the tumor. In several different trials from other companies, it has been shown that adding different medical modalities on top of PD-1, PD-L1 has improved outcome for patients. This is a competitive space, but we are in that space with three different trials. And just to put these two classes of checkpoint inhibitors into context, on the next slide, you can see the immune cycle. This is a very simplified version of the immune cycle, but just to present where the two different classes of checkpoint inhibitors belong.
Down in the middle, the brown, big lump there is representing a cancer tumor. In the tumor, cancer cells will die, and then tumor antigens will leak out and be taken up by so-called antigen-presenting cells. That is presented with the pink or purple cells to the left in the image. The antigens are then presented to the immune system, to the T-cells, and if they recognize the antigen, the T-cells will start to expand, meaning that few T-cells will become hundred thousands, millions of T-cells. These T-cells will then migrate throughout the body, as presented on the right side in this image, and identify their target in the tumor. In real world, when these T-cells are actually identified their target in the tumor, the tumor will start to defend itself by adding molecules on the surface.
One of these molecules is this PD-1, PD-L1 axis. That gives a signal to the immune system that you should not attack me. And by adding drugs like nivolumab or pembrolizumab, this checkpoint is taken away so that the T-cell can have efficacy in the tumor and draining lymph nodes. The other class of checkpoint inhibitors and the CTLA-4 or ipilimumab, is working in a different place in this circle. If you look up to the left under number one, there is an antigen-presenting cell there in purple, presenting antigens from the tumor to the immune system. In biological circumstances, when the immune system recognize its target, it will start to proliferate, as I said earlier, but after a while, this expansion of the T-cells will wear off. It will stop.
If you add checkpoint inhibitors like ipilimumab, this process is allowed to continue so that you have a stronger immune response. Moving on to the next slide. So here you can see the phase II program in Ultimovacs. To the left, two trials, the NIPU trial and the INITIUM trial, where we have combined with ipilimumab and nivolumab. To the right, three trials where we combined with monotherapy checkpoint inhibitors, pembrolizumab, durvalumab, and cemiplimab. The common denominator for all these five trials is that they express telomerase, so the target for the T-cells we expand is in the tumor. There are different combinations, and there are different biologies. Looking at the first two trials, which have reported results. So on the next slide, you can see the design of the NIPU trial. We have also been through this earlier.
The milestones here is that results was presented at ESMO Congress last autumn, and updated overall survival data will be presented at the medical congress during 2024. For the results from the NIPU trial on the next slide, we did not see added toxicity for patients when you added UV1 on top of ipi/nivo in this trial. The primary endpoint, as judged by a central review of the images, was negative PFS primary endpoint. It was also a pre-planned sensitivity analysis defined in the protocol, where the images were through local assessment. In this analysis, the PFS gave a clinically different result clinical relevant result for the patients.
When it comes to other endpoints in this study, we did see, as Carlos mentioned, a reduced risk of death by 27%, and also an improved response rate in the UV1 arm, 31% versus 16%. The data was sent off to U.S. and European authorities, and we received back different designations. We have discussed the trials with the regulatory authorities and investigators, and the feedback is that the findings in this trial warrant further development of UV1 in mesothelioma. Moving on to the next slide, the INITIUM trial design. So the milestones here was that the top line results were reported in March, and the trial results is to presented at the medical conference during 2024.
Looking at the results in this trial, also here, we did not see any—on the next slide, we did not see any difference in the safety profile between arms. Ipi and nivo performed much better than expected in the population included in this trial, if we compare with historical data. We do not have a good answer for this, why it happened in this trial, but that the distribution of patients with different characteristics was equal between the two arms, so no difference between the arms. The primary and secondary endpoints results doesn't warrant any further development of UV1 in combination with ipi and nivo in this indication, unresectable advanced melanoma. We do not have an answer why UV1 didn't work in this indication.
In a highly immunogenic tumor type like malignant melanoma, there is a lot of antigens. And when these antigens are presented to the immune system, with also, ipilimumab being a part of the combination, it might be generated enough T-cell responses with that combination alone. Moving on to the next slide. We have started our phase II program, and it's important to emphasize that this program has been designed to cover different biologies, different combinations of drugs, for patients. And this is the strategy that you go out broad, so that you hopefully will find indications where UV1 show efficacy on top of the standard of care. In most programs where drugs are developed, there will be trials that fail, and hopefully some of the trials will succeed.
We have now gone been through two readouts, where we have combined with ipi/nivo. For the next three trials, there will be results from PD-1, PD-L1, and UV1 combinations. Moving on to the next slide, the focus. Now. The next part of the program. So in this part of the program, there are three different indications: first line, head and neck cancer, second line, ovarian cancer, and first line, non-small cell lung cancer. In these three trials, we combine with monotherapy CPIs. Looking closer at these trials, first, the FOCUS trial on the next slide. The update here or the milestone here is that the top line results from this trial is expected in third quarter this year.
This includes a readout of all endpoints up to 12 months, and primary endpoint at six months, which was the predefined primary endpoint in this trial. On the next slide, you can see that head and neck cancer is arising from the linings in the cavity in the throat in the nose, and in the sinuses in the face. It's the seventh most common cancer globally. In this cancer, telomerase is highly expressed, and pembrolizumab is considered a standard care for patients with PD-L1 positive tumors. So there are three different treatment regimens for these patients. You can either treat with pembrolizumab or pembrolizumab plus chemotherapy if you are PD-L1 positive. If you are PD-L1 negative, you are treated with chemotherapy only. Moving on to the next slide, the DOVACC trial.
The milestones for this trial is that top line results are expected first half of 2025. A few words about the background for this indication on the next slide. So it's arising from the epithelium surface in the ovaries. It's the second most common gynecological cancer, and it's the leading cause of death from gynecological cancers in the world. Ovarian cancer is the eighteenth most common cancer overall. Standard treatment for these patients includes surgery, chemotherapy, PARP inhibitors like olaparib and bevacizumab. Several studies have shown the added efficacy when PARP inhibitor and checkpoint inhibitors are combined in these patients. And also in this indication, telomerase is highly expressed. Moving on to the next slide, the LUNGVAC trial. The top line results for this one is expected in first half of 2026.
On the next slide, a few words about the LUNGVAC indication. So it's arising from the tissues in the lung, it's the most frequently diagnosed cancer and a leading cause of cancer death worldwide. PD-1, which we combine with, is considered standard care for the first-line treatment of these patients if they are PD-L1 positive. And also in this indication, telomerase is expressed. Moving on to the next slide, I give the word back to Carlos for the way forward. Thank you.
Thank you, Jens. So if we move to the next slide, you know, just, you know, a familiar slide for all the investors that follow us. You know, we continue to expect data from the 103 study in terms of survival. But of course, now the key drivers in terms of data are gonna be the FOCUS trial and the DOVACC trial. You know, the NIPU trial, you know, we have the data supporting the further development of the UV1 in the mesothelioma indication. But of course, as usual, we continue to wait for the investigators to update part of this data and present at medical conferences.
So if we move to the next slide, you know, again, and to, as a takeaway message, you know, I want to assure everybody that we remain confident really in the UV1 potential and the, the team, and particularly the, the ones that will remain in the company, are strongly committed to bringing Ultimovacs across these next important milestones, the readout of the FOCUS and the DOVACC trials. It's important also to emphasize that the investigators in these, in ongoing trials are fully dedicated of bringing UV1 across these important data points. They spontaneously, you know, call us and, and saying that how committed they are to, to really running these trials. The strategy of developing UV1, focusing on a randomized control program, exploring different cancer types and immunotherapies, remains unchanged.
You know, Jens mentioned, you know, this is not unusual to have same combination, same treatments, succeeding some indications, you know, and failing in other ones. You know, and just recently, ipilimumab and nivolumab combination didn't show in a different cancer type, didn't show a benefit over nivolumab alone. So again, this is additional proof that this is a natural finding in the development of different therapies. So really the, you know, these results and substantiate and support the decision of the company, taken some years ago, of really implement a broad program despite, you know, being a small team, and particularly in the light of different results as seen in the standard clinical development. We are on course with our phase two program.
You know, we expect, of course, the data from the FOCUS trial now in the Q3, and according to the investigator in the DOVACC trial, you know, his expectation is to deliver us data in the first half of 2025. The reprioritization, the operation and the plans enables really to extend the financial runway to the fourth quarter of 2025, well beyond the anticipated top-line readout for the phase II DOVACC trial. So, I want to thank everybody, particularly the ones that continue supportive of Ultimovacs and our goal of bringing really UV1 across these extended timelines for the FOCUS and the DOVACC trial. And with this, I would ask Hans if we have had any questions. Hans?
Yes, Carlos, thank you. We have received some questions, and I can start with two questions to probably be answered by Jens, related to further data from the INITIUM trial. The first one, I can read both of them. When can we expect to get more high-level data, like a couple of major plots, including results from assessment or subgroups from INITIUM? And a similar question, the top line from INITIUM has a ratio with a confidence interval and a P value. You have still not communicated the confidence interval or the P value. Why do you still believe attendance at medical conferences is important enough to withhold the top-line data?
Thank you for those questions, Hans. So, the INITIUM trial, as all the other trials, involves patients, and it involves investigators that are using their time to try to improve on the treatment for their patients. So this trial has an interest, of course, from UV1 and Ultimovacs side, if UV1 works or not. The trial as such, also has an interest in a broader sense. For example, in the INITIUM trial, there are 156 patients that are reviewed with a central review. So we have a lot of information on ipi/nivo. I guess the results from this trial will go into the debate between the different- how to use the different CPIs moving forward, for example, ipi/nivo versus LAG-3/nivo.
So the findings, even if UV1 didn't show an efficacy on top here, it's very important that these results are discussed by the community. Another thing is that combination in the INITIUM trial, so as I said, we combined with ipi and nivo. We did not see UV1 efficacy on top of that combination in these indications. We do hope that presenting these results will start a debate, what kind of CPIs you should combine with in different indications. As a tentative hypothesis, it could be that ipi/nivo is enough in the melanoma patients to generate good T-cell responses for the patients. So therefore, then the data will be presented at the medical conference in full and also presented in a journal as soon as possible.
Thank you, Jens. Then we have two questions also to you related to the further progress in the INITIUM trial. The first, if any breakthroughs come in related to INITIUM data assessment, will they be published right away or later in connection to ASCO/ESMO or a paper in a medical journal? And I would like to then add another question. Does the INITIUM study continue until 2026, as indicated in ClinicalTrials.gov?
I can answer the first part of the question, at least. So, we have looked through the data in the INITIUM trial, looked at different subgroups, for example, and then there is no difference in any subgroups in the INITIUM trial. Also, just to be clear on that, in the INITIUM trial, we did not take biopsies from the patients, so we do not know the PD-L1 status of patients, in the INITIUM trial. That is something that is done in the single-arm cohort, connected with the study. Yeah, I don't know if you want to answer the second part of the question, Carlos, regarding end of study.
Yeah, you know, so, of course, part of the, as you know, the analysis of and follow-up of these patients will be primarily for survival, you know, as it's the normal. And, you know, looking at the results and seeing how, you know, majority of these patients are really in this kind of a flat line of response and survival. Part of our assessment in this reprioritization of projects, we have decided that, in the INITIUM trial, we will stop analyzing survival with this data, as we don't see a benefit in continue.
As for instance, in the historical studies with ipi/nivo, you can expect that, you know, this follow-up will need to go for by seven to 10 years for you to see a difference. So we don't think that this is productive, and we of course want to now utilize the resources, financial, and in terms of manpower behind the studies that are ongoing.
Okay, another question related to the INITIUM trial. I'm not sure which, who of you will answer this. In any trial result, there is a theoretical possibility of having conducted a type two error. In a relatively small trial like INITIUM, this is not negligible at all. Why do you, why do you not mention this possibility at all?
When the trial is presented, I totally agree with that. There is risk for both type one and type two errors, and the statistics is weaker in a phase II than in a phase III trial. This is, of course, something that will be discussed in a presentation and publication. This is a part of the standard reporting of clinical trials and will, of course, also be included in such presentations and publications for the INITIUM trial.
Okay. Another question for you, Jens. How many events were there in each arm in the INITIUM study?
So this will be presented at the ASCO conference, hopefully, or in a presentation at the later stage, or and also in the publication of this study. But the conclusion from this study is that the primary endpoint was not met, and none of the secondary endpoints were met, and there were no results in the subgroups in this study that warrant optimism for the further development of the INITIUM trial with the ipi/nivo combination in that patient population. But we move on to new indications with different biologies and different combinations of drugs now over the next year.
Thank you, Jens. Then a question related to the FOCUS trial. The primary endpoint for the FOCUS study is PFS after six months, which already has passed. How many people have this information already, and why is the market not informed of the result for this primary endpoint?
In the head and neck trial, we combined with pembrolizumab, UV1 plus pembro versus pembrolizumab. The primary endpoint is a landmark endpoint, PFS at six months. Phase II trials, they are performed to understand what kind of efficacy signals you can expect when you add something new on top of already standard of care. It's important to evaluate the different endpoints. So we decided to wait for 12 months follow-up of overall survival to be able to put the PFS results. We will have it now in quarter three, in association with the overall survival seen in the study and also other endpoints. So nobody knows about this today. The database is not clean. So there's nobody sitting on this information, but it will be available in quarter three.
Thank you, Jens. Another question related to mesothelioma. Can you comment on any update for your plans in mesothelioma? For instance, looking for partnership, planning phase III, or waiting for further phase II results in other indications.
Well, yeah, I can take on that one. You know, we have the data, we have the support from investigators and authorities. But of course, as I believe everyone will understand, you know, running a phase three requires money, and it's important that now we get the results from the next studies in order to make an assessment. So, the interest is there, the execution will need to wait a little bit longer.
Okay. Thanks, Carlos. Two questions related to further enrollment in other trials. I'll ask both of them. After the failure of the initial study, are we afraid of the further recruitment for the remaining trials? A similar question, what are the plans for the LUNGVAC trial, which is only approximately 15% enrolled? Do you anticipate a slowdown or a halt in the trial?
You know, I can cover that. You know, when we will, of course, provide as usual, an update on the enrollment with the next quarterly report. I can confirm, and Jens already mentioned that, you know, the DOVACC trial is moving quite nicely. We know that there are more challenges with the LUNGVAC study, and the investigators are looking at ways of accelerating that enrollment. It is something that we need to, you know, as everybody knows, these studies are not our studies, are investigator-initiated studies.
So in the LUNGVAC, the investigators will need to assess the situation and at a certain point in time, discuss with us how they see the further development of the study, if it makes sense to continue or not. You know, that will have to be, in the first instance, a decision from the investigators that will be shared with us. At the moment, both of those studies continue enrolling patients, and as everybody knows, the DOVACC, you know, more successfully.
Thank you, Carlos. Then another question, I guess to Jens regarding dosing. Why haven't you tried with higher doses of UV1 in combination with the checkpoint inhibitors?
So when we are trying to optimize the dose, for a vaccine, as we did in the early trials, you do different dose levels, and you look at the immune responses, and you look at safety for patients. The results we had from the phase I program, and after discussion with the authorities, we decided to go for a middle dose. We had 100, 300, and 700 micrograms. So it was agreed to proceed development of the vaccine with the middle dose, based on the benefit-risk assessment, of the drug or the vaccine.
Thank you, Jens. One question that has been at least partly addressed already in the presentation, but I'll ask it for sake of completeness. In parallel to the phase two program, Ultimovacs has presented encouraging long-term survival data from a phase one study assessing UV1 in combination with the CPI pembrolizumab. Do you think the choice of checkpoint inhibitor has a potential role to play in the results, or could there be other reasons for this disparity?
Very difficult to answer. So, that is a single-arm trial, so we can not attribute efficacy to UV1 alone, or the combination, or if pembrolizumab is performing better than expected. But, I think it's very interesting results in the 103 trial. Three different things. First, the good long time overall survival with a flat line around 70%. And the next part is that there was a lot of complete responses. It was more complete responses than partial responses, which is uncommon to see, if you have a checkpoint inhibitor trial. It's more usual or always more partial responders than complete responders. Also, we did see in that trial that the response in PD-L1-negative patients were the same as in the whole group of patients.
So, it seems like if UV1 has clinical efficacy in that, in the indication and that combination, so it seems like UV1 then have added on the effect of pembrolizumab. But to be sure about that, it needs to be done in a randomized trial.
Yeah, and just if I can complete there, and that, and that is the benefit of the, for instance, the FOCUS trial, you know, where we have a randomized trial in with pembrolizumab alone, and the other arm adding UV1. A totally different indication, of course, head and neck. For instance, pembrolizumab has a poor efficacy. Around 18%-20% of the patients respond to pembrolizumab alone, so a very high medical need, and that will also give us a lot more information.
All those patients, you know, have biopsies, so we will get different type of data and then we see again if maybe, as Jens mentioned, the hypothesis that in less immunogenic cancers, you know, like mesothelioma or head and neck, you know, then we can provide a added benefit even if it ipi, the ipi is not added to that combination. So this is the part that we, you know, both Jens and I mentioned that the importance of having all these trials and collecting as much information from each of them to really support us in our decisions to move forward.
You know, of course, if we have a positive FOCUS data, then, you know, we will be, you know, proceeding with all the activities expected, you know, then discussing with the authorities, you know, discuss with partners, but we need to wait for that data.
Thank you, Carlos. One question on vaccine technology, I guess that goes to Jens. Your patents cover the use of your peptides and coded by nucleic acid molecules. If you still believe the peptides in UV1 to be especially relevant, when hTERT is the target, but maybe too little immunogenic by themselves, could an mRNA version or UV1 be interesting for someone else? Is it possible that you explore this business development opportunity in the coming months?
Well, we have to look at all the different opportunities going forward. Just to comment on the immune responses with peptides. So, using the peptides in the UV1 vaccine, we know that T -cells that recognize sequences or epitopes within those peptides are proliferating in the body. So we know that we make good immune responses. We also know that the immune responses or the T -cells that is expanded, they have the right features. They express the right cytokines, which is needed for T -cells that want to attack something that is within the cell. So it's Th1 derived, and they express the right cytokines. Also, other technologies can be used to expand such T -cells, like DNA and RNA.
There is, of course, no decision on that now, but we discuss every opportunity we have moving forward.
One question for Carlos: The management says through the presentation that they remain confident. Why does the management then sell shares in Ultimovacs more than invest in the company at current levels?
You know, I think, any transactions done by members of the management are individual decisions. Everybody has different needs and situations in life that are to be assessed on an individual basis. You know, what is important here is, you know, I'm, you know, I, as an insider, you know, continue invested in the company. You know, the major owners, Gjelsten Holding, you know, and Radforsk Investeringsstiftelse, even to remain committed to the company. And, more than transactions is the team committed and being still connected with the company to bring it across these value inflection points. Any transactions done by the team members are an individual decision and are dependent on situations in each of these lives that are private.
Thank you, Carlos. Another question: What is your take on the company situation if both the overall survival update in NIPU and the top line results from FOCUS do not show significant benefits from UV1? And on the other hand, what if there are shown clinical benefits?
I think we need to separate the data. You know, in NIPU, you know, we already have data supporting, as mentioned, the continued development. You know, it's more of a strategic decision at the moment in terms of financing of that. So additional data from NIPU is, you know, is just going to potentially complement that. But let's not forget that you know, these are patients in second line that are seriously sick and die very fast. So, you know, we need to take that in consideration, but the data is already positive, supporting further development. FOCUS is a different story. You know, we don't know the data. We don't have the data.
But if the data in FOCUS is positive, basically, we triggers a renunciation of a lot of the pivot activities that were planned to be done, you know, with a positive INITIUM study. You know, discussion with the authorities, talking with partners, and discussing the next development phase. If FOCUS is also negative, you know, we, the company, and I think that was mentioned, you know, that and supported by the major owners and the board. You know, we still think that, you know, it makes sense to wait for the DOVACC data, and the company is prepared to do that, even if the FOCUS data is negative. So this is really we see, we see that this is not unusual.
You know, Jens could probably talk about this, but, you know, there are major companies that, for instance, the first seven studies were negative, and the only the eighth study was positive. So of course, we don't have the luxury of it being a big pharma, but, but there is all rationale and history in terms of development of immunotherapies that make sense that, you know, to, to also wait for the DOVACC results. Again, a totally different, totally different indication, a total different combination, so it's, for what, hopefully we were able to, to really, talk, during this webcast.
There is a rationale to wait for these different data because these diseases are totally different, and they are treated differently, and the efficacies are expected efficacies of the current treatment are also very different from one to the other.
Thank you, Carlos, and then we receive one last question here that is a financial follow-up on what you just discussed. Does the new runway outlook change timing or potential issue on new shares?
Well, you know, what we can communicate is that we have an extended runway. You know, any capital raise and financial decision will have to be discussed by the board, and assessed at that time. You know, we have no comments at the moment. You know, all the work was done to really with the current cash situation in the company to extend the runway across both FOCUS and DOVACC trial.
Okay. Thank you, Carlos and Jens. That was all the questions.
Okay. Thanks, Jens, thanks, Hans, and thank you, everybody, for listening to us and for all the questions that you asked. You know, we will give you further updates, the next one with the quarterly report. Thank you, and have a great day!