Good afternoon, everybody, and welcome to Ultimovacs' Q3 2022 results. My name is Carlos de Sousa, I'm the CEO of the company, and as usually, I have with me Jens Bjørheim, our Chief Medical Officer, and Hans Vassgård Eid, our Chief Financial Officer. I wanna thank all of the shareholders that have been sending us questions, but as we go through the slides, if you have additional questions we want to handle during the Q&A session, please don't hesitate to use the system and send us your questions, and we will try to answer as many as possible after we go through the presentation. With this, let's move to the next slide that you know I have to show you is the disclaimer.
If we go to the next slide, I think, you know, we have to recognize that Ultimovacs continues on a consistent path of, you know, very successful, quarterly, results and achievements. We are really at an exciting period for the company, as we are moving, you know, very strongly towards key milestones. These key value inflection points to the company are the readouts for the first two UV1 phase II clinical trials, INITIUM in melanoma and NIPU in mesothelioma. That is, you know, are expected around the corner during the H1 of 2023. We have been continuing to have a very overall a good patient enrollment. We have initiated the enrollment in LUNGVAC, and now we have three patients enrolled.
Of course, as you know, we concluded the enrollment in INITIUM, you know, in June. Jens, of course, will cover more details about this enrollment. Also, during this quarter, very encouraging data, not only in terms of the three-year overall survival that we reached 71% in cohort 1. Means that after three years in this cohort, 71% of the patients are still alive. Also very exciting data regarding biomarker in the phase I study, UV1-103, that was presented at a recent congress in our treated patients that really appear to benefit from the addition of UV1 to when they are treated with pembrolizumab or KEYTRUDA. Jens will also cover this. We continue with a very strong cash position.
In these very volatile times, this is a very good place to be. Our expected runway takes us to the H1 of 2024. Hans will cover all these details on the financial part, you know, later in the presentation. I will give the word now to Jens, and then I will come back at the end. Jens?
Thank you, Carlos. Good morning and good afternoon to the listeners. We are moving to the next slide. You can see the pipeline in Ultimovacs as of now. I know you have seen this slide several times before, but just some reflections. The upper three lines in this slide represent our lead indication in malignant melanoma. We have conducted two phase I trials that we have reported results from, and I will come back to that shortly. Also the third line with the INITIUM trial, which is our phase II trial, randomized trial, that we expect readout H1 of 2023. As we have discussed earlier, there has also been a lot of interest around the vaccine from other academic groups and pharma.
We are participating in four different phase II trials in mesothelioma, the kind of cancer you can contract after exposure to asbestos, ovarian cancer, head and neck cancer, and the last one, non-small cell lung cancer. On the next slide, you can see the enrollment in the different trials as of now. As you know, the INITIUM trial was fully recruited June this year. We started recruitment in June 2020, so two years of inclusion during the pandemic. We are very happy that this trial is fully enrolled, and we really look forward to the readout of this trial. Also, in the NIPU trial, there's good enrollment. 108 out of 118 patients are enrolled as of now, compared to 92 patients at last drop report.
In the FOCUS trial in head and neck cancer, enrollment is also progressing well with 41 patients enrolled versus 27 at the latest report. For the DOVAC trial, we have earlier discussed that it has been more work than usual to start up new sites. New sites are now opening in different countries in Europe. We do not see that too much on the enrollment as of now, but we expect this to pick up over the next period of time. Happily, the LUNGVAC trial, the last phase II trial, enrolled the first patients now over the last weeks. Three out of 138 patients enrolled in LUNGVAC as of now.
For the TENDU trial, which is the phase I trial with a different platform, the TET platform, we have enrolled 10 out of 12 patients to date. Moving on to the next slide, you can see here the two trials that will likely report H1 of next year. For both these two trials, they are randomized phase II trials, meaning that there is a control group of patients, and there is an experimental arm where we have put the vaccine on top. In both these phase II trials, they have a so-called endpoint driven design. That means that we are awaiting a predefined number of endpoints to occur before we close the database and look at the results. As I said, this will happen most likely H1 of next year, 2023.
The primary endpoint in these two trials are progression-free survival, meaning that the tumor is growing or if the patient die. On the next slide, you can see the results from the second of our two phase I trials in our lead indication, malignant melanoma. As you know, we have reported on most of these results already at ASCO 2021, where we saw a complete response in 10 patients and a partial response in 7, a stable disease in 2 patients, and progressive disease in 11 of the patients. Also, the median progression-free survival has read out in this trial at 18.9 months. New information were given back in August this year, where we reported on the overall survival for the first cohort of patients in this study, three years overall survival at 71%.
To the right in this slide, we have compared the results with the KEYNOTE-006 trial. There are some difference between the KEYNOTE trial and our trial. In the KEYNOTE trial, all patients are stage 4, a little bit above 60% are stage 4 in our trial. Most of the patients that are not will be stage 3C patients. With pembrolizumab alone, it has been seen a complete response rate between 5% and 12%. When we added UV-1 on top in our study, we saw 33% complete response rate. For the objective response rate between 33% and 37% for pembrolizumab alone, versus 57% in our trial. I would also like to emphasize that in this study, as in the other phase I trial for malignant melanoma, it has been a very good safety profile.
Most safety that has been reported is as expected for the CPI, the checkpoint inhibitor alone, except for injection site reactions. This is very good news for further development of the drug, as it doesn't seem to add very much safety on top of the safety you expect from the checkpoint inhibitors. On the next slide, you can see a picture from a conference that was conducted in Edinburgh a few weeks back, the SMR conference, Society for Melanoma Research. This conference is a specialist conference for doctors and academic people working within the field of malignant melanoma. We were very happy that we were allowed to present our phase I data in the plenary session there. The presentation were done by Yousef Zakaria.
That was very good for us, and I do hope that it was a good performance also for the audience. We have received a lot of good feedback on that. On the next slide, some of the results from the earlier slide is repeated. This is the progression-free survival to the left with reading out at 18.9 months and the overall survival curve in the middle. One thing that is important with this, Kaplan-Meier curves is that you would like to understand how the endpoints develop over time. As you know, for checkpoint inhibitors, after a certain period of time, the curve is flattening out, reaching this so-called plateau, where patients are in a stable condition for a long time.
That is one of the things that characterize checkpoint inhibitors and treatment towards the immune system, that there is a higher frequency of patients with long-term survival and response as compared to earlier treatment regimes like chemotherapy and small molecules. If you go to the next slide, we can see some information on these patients in a more granular version. To the left is so-called waterfall plot. In this plot, you can see the change in tumor size from baseline, meaning prior to treatment, until the best achieved response for the individual patient. Each column represent one patient, and you can also see two stippled lines here, one at 20%. If the tumor grows more than 20%, that means that the patient has a progression, that the tumor is growing.
If you are below the -30 line or in stippled line, that means that you have a response. If it's not 100%, it's a partial response. If it goes all the way down to 100%, it's called a complete response. This is the best response for each of the 30 patients in our study. Up to the right, you can see a spider plot. You also here you start at zero. That will be the volume of your tumor prior to treatment. Then you can follow the volume of the tumors in the patient's body over time.
Each point here represent a new picture of each patient, and every line represent one patient. You can see all those patients that are below - 30% are those patients that are in a partial or complete response. In malignant melanoma, it's allowed to treat all patients with different checkpoint inhibitors. We do not do any biomarker analysis prior to inclusion or treatment of patients. Nevertheless, in the large studies that has been conducted, the scientists have tried to understand if there are groups of patients that respond better to checkpoint inhibitors than others. It has been seen that if you have high levels of PD-L1 expression, one of these biomarkers, you can expect in a group of patients to have better response than in those patients with a lower PD-L1.
When we added the vaccine on top of pembrolizumab in our study, we did not see this difference. Actually, in those patients with a low PD-L1 expression, we saw an even higher response rate compared to those patients with a high PD-L1 expression. This is also something we did with other biomarkers like tumor mutation burden, interferon gamma signature, et cetera, and we saw the same pattern with all the biomarkers used by the scientist to have some kind of view on checkpoint treatment alone. On the next slide, you will see a comparison between overall survival with pembrolizumab alone and pembro plus UV1 in our trial. Also here, we have used the KEYNOTE-006 data at one and two years. The overall survival with pembro was between 72%-75% and 58% respectively.
In our trial, 87% after one year and 73% after two years. We will follow these patients over the next years to see how this curve, this Kaplan-Meier curve, develop over time. Also for the median progression-free survival, as reported earlier, pembrolizumab has read out between 5.5 months and 11.6 months. Adding UV1 on top, we saw a readout at 18.9 months. Moving on to the next slide, we here have a short presentation of the TET platform. The TET platform is our new adjuvant strategy. An adjuvant strategy where we can combine the adjuvant with the peptides, with different peptides in one molecule. What we do here is that for patients or people that are vaccinated against tetanus, those patients will develop antibodies that recognize a sequence in the tetanus toxin.
They will have antibodies that can bind to this sequence. We have made a molecule consisting of these sequences, and attached to that molecule you can bind different peptides. The thinking here is that when you inject this in patients, there will already be antibodies present in the body that will bind to the molecule, and the molecule will be actively taken up into antigen-presenting cells, those cells that present foreign material to the immune system. To this tetanus toxin molecule, we can add different molecules, different peptides, in different setups. This gives us a huge opportunity to develop different cancer vaccines in the future. Right now we're in a phase I with this project. We have a small trial called the TENDU study.
In that study, we include patients with prostate cancer and attached to the tetanus part, we have prostate cancer antigens. The ambition with that study is to understand the immune responses that develops when we vaccinate, also the safety profile with the drug, and to understand more around the dosing, how much of this drug we should give to the patients in the future. This will give us a lot of valuable information moving forward with this interesting platform technology. On the next slide, we will move into the financial part of the presentation. I give the word to Hans. Thank you.
Thank you, Jens. Moving on to the key financials for this quarter and year- to- date. The most interesting parameter here is the total operating expenses. If we look at the total operating expenses for the last quarter, we see, and compared to the last year, we see that there is a slight increase. If we look at the year-to-date number, or NOK 111 million, it's a slight decrease or more or less the same as the previous year. Behind these numbers, there is a general increase in R&D expenses.
When we look at the personnel expenses, we'll come back to the details in a second. We see that there is a reversal of some accruals that brings the total cost down. We'll go through the details here. Starting with payroll expenses, the total payroll expense in the last quarter and year- to- date were lower than the previous year. This has sort of two explanations. Looking at the regular salary costs, we had a slight increase in both the last quarter and year- to- date compared to the previous year as we had two more FTEs this year. However, the fact that we have a decrease in total payroll expenses is mainly due to share option costs.
The last quarter and this year, we have had a reversal of some previous expenses. Because these share option costs fluctuates with the company share price, and with the decrease in the share price earlier this year, this implied a reduction in the costs. That's the explanation. Moving on to the R&D expenses. The R&D expenses, both in the Q3 and year- to- date, were higher compared to the same periods in 2021, and this is primarily due to milestone payments in clinical trials, as well as higher manufacturing or CMC costs this quarter. Looking at other operating expenses, we have an increase from the previous year. This is primarily driven by higher activity level in areas like business development and travel expenses.
Travel expenses is naturally picking up after the pandemic. Looking at the financial items, we had the last quarter net gain of NOK 4 million related to the currency positions. We have some funds in a Euro account and also some Euro-NOK future contracts to hedge the currency risk. Year- to- date, we had a net gain of close to NOK 10 million from these positions. These are positive contributions to the total P&L. By the end of the Q3, we had a total cash, as Carlos mentioned, of NOK 469 million or roughly $43 million. This gives fairly comfortable funding position, and we have an expected financial runway to the H1 of 2024.
This is the same guidance as we have been giving for quite some time, now. Looking ahead, we do expect the operating expenses and the negative operating cash flow to increase somewhat, and this is consistent with the guidance we're giving on the financial runway. We can move to the next slide. We are here sharing a picture of how the operating cash flow has fluctuated quarter- by- quarter, and we will expect to see quarterly variations also going forward. It's the R&D expenses that really drives these changes.
With further initiation of sites and patient recruitment in clinical trials, with the milestones reached in larger projects, with some changes in the CMC development, the manufacturing costs, and also other R&D expenses, there will be- w e will continue to see variations. Largely speaking, we expect a somewhat higher level of costs going forward. Yes. We have on the next slide just a quarterly breakdown of the operating expenses. This is more as a support to analysts who would like to dig into the numbers. We will not spend more time on that in this presentation. With that, we move on to the next section, and I leave the word back to Carlos.
Thank you, Hans. If we move to the next slide, we always like to also cover what has been some of the developments in the immuno-oncology space. I think we would like to highlight two recent developments. You know, one is, you know, and this was very, very public during the ESMO Cancer Conference, you know, in September. The increased focus from oncologists and pharma companies on moving to earlier stages of treatment of these patients, what is called a neoadjuvant treatment across different cancer indications. At the conference, there were different results.
You know, probably one of the most you know became very public and visible was in the study, the NICHE-2 in colorectal cancer that was presented by the specialist that you see in the image where you know picking up on this waterfall graph you can see that basically there was a response in 95% of the patients in this specific study. This, of course, is creating more and more excitement around treating patients earlier particularly in melanoma for instance is to start treating patients before the primary tumor is removed.
This is also an area that we are, as a company, you know, exploring more and discussing more internally because we see also that this is a stage of the treatment that will benefit more also from the entering of a cancer vaccine like UV1. The other part, the other news, you know, that we believe are positive for the overall space of the cancer vaccines. As everybody knows, the cancer vaccines have not been, you know, very popular for many years. I think that is changing. You know, it start changing with the COVID vaccines, you know, raising the awareness of the vaccines in general.
The big developments with Moderna and BioNTech that, you know, although they produced COVID vaccines, or they could do it in a fast way because they have, you know, more than 10 years of experience of working with cancer vaccines using a similar technology. This became now even more coming to the mainstream and more public with the recent deal that Merck exercised the option that they had with Moderna. With BioNTech coming more to the market, says that they expect their cancer vaccine to be, you know, out, you know, by 2030. You know, we see this as positive in the sense of raising awareness of cancer vaccines. It's not a direct competitor to Ultimovacs.
These are what we call personalized vaccines. Of course, it's always a good development, and we expect if the data is positive to even be out on the market before they do. Anyway, very positive developments that we see in the overall space that are also supportive of the work we are doing. Let's talk about, you know, the month ahead. If we move to the next slide, you know, yes, we have been, as a company, delivering on our promises very consistently.
Of course, it's in the top of everybody's mind, you know, the next six to nine months, you know, when we are gonna have the initial readout with NIPU that we expect is already several times mentioned during the H1 of 2023. Of course, these are, you know, very exciting times. We, of course, you know, if the data is positive, this will be revolutionary, and for us as a company but also for the space overall because this will be, you know, a universal cancer vaccine. You know, really, if the data positive showing in a comparative randomized study that cancer vaccines have a role in treating cancer patients.
If the data is positive, as you can imagine, and we have been very public about that, you know, on one hand, we will be meeting with the authorities, presenting the data, discussing the next steps. If the data is very positive, you know, consider with them if there is room for a conditional or accelerated approval. On the other hand, you know, we have, as you know, we have been told that we continuing in regular communication with big pharma companies that could be strategic partners in licensing UV1. Of course, these contacts in the back of positive data will accelerate.
You know, we see a big number of companies that with positive data could be interested in taking on UV1, and we see this as positive not only for our investors, but also for our patients. You know, as a company, we are totally prepared to with positive data to move into one or two phase III studies. But a large pharma company, of course, will have all the pieces in place for them to initiate multiple phase III indications in different cancer types. You know, that will be, of course, of great value also for patients.
Very exciting times and we are also now, you know, in preparation also for this data, you know, continue to putting a lot of emphasis on raising awareness of the company. In medical conferences was extremely rewarding to get a presentation at the SMR conference in the main plenary session. In addition to the medical community, we continue talking with pharma companies, and we are also increasing substantially the contact and raising awareness among investors and particularly specialist investors, you know, in the rest of Europe and also in the U.S.
That is gonna be really a lot of the focus of part of the team is in expanding those contacts and bring awareness of Ultimovacs and what we do and the forthcoming data to these specialist investors. Of course, then, you know, we will have the other studies coming later on. We will be providing you with an updated guidance with the Q4 2022 report. If we move to the next slide before we move to the Q&A. Basically, you know, I just want to take the opportunity to thank the team.
They have been doing a great job of making sure that we continue enrolling patients, really working on the data and getting this exposure medical conferences, very actively working in the background, you know, doing a lot of these other activities that are not so visible, like developing a commercial process for the product, preclinical studies, all these mechanistic studies that the data is very positive and also the emphasis in raising awareness of the company. A big thanks to the team, but also of course to all of you that continue to support us. We hopefully can show t hat we have been delivering .
Continue to support us . We have these exciting period of time coming just around the corner. We continue to have a good overall good patient enrollment. The positive data that we have been showing so far in the 103 study is very encouraging. Of course, you know, the more I talk with colleagues, other CEOs in other biotech companies and with advisors, we see that we are in this very good place in terms of our cash position that allows us to be focusing on the business without having to face the big hurdles of trying to finance a company in these very volatile times. With this, I want to thank you, all of you, for the time you gave us to present the company and for all your support. We will move now to the Q&A.
Okay. Thank you, Carlos. We have received quite a few questions, and we may start with a couple of questions related to the UV1-103 trial, and I think Jens will be the one to answer those. The first one, what is the reason for eight patients in UV1-103 missing PD-L1 status?
The reason for that is that when you try to collect tissue or biopsies from the patients, sometimes it's not possible or the quality of such specimens are not good enough. We actually do have information from 22 patients, and the last 8 are missing due to this.
Thanks, Jens. Another question related to comparative data. The question is, considering the differences in patient populations in UV1-103 and KEYNOTE-006 that you talked about, wouldn't it be more accurate to compare KEYNOTE-006 results to the stage four patients from UV1-103?
Well, it's never very good science to compare different trials. As long as they are not conducted head to head, you will always just get an indication. The reason why we are presenting data from the KEYNOTE-006 trial is that this is the registration trial for pembrolizumab, and we think it's valuable that the audience see the results for pembrolizumab alone. There are no trials that cover the same patient population as we do. Since this is not strong science from the start, we do not want to go into subgroups and try to identify patients in our trial and compare them with specific patients in other trials. This is just to give an indication of the safety signals in our trial.
I just also want to emphasize that, we do think one of the most interesting, efficacy, signals in our trial is the number of, complete responders. We see really a push from stable disease and partial responses toward, complete responses, which we saw in 33% of the patients. Now there's only a few months or a half a year until, we will have, results from a randomized trial. In that position we can discuss further, the efficacy, with UV1 on top of, CPIs.
Thank you, Jens. Another question to you. You have done nice work with the PDL-1 biomarker to support the efficacy and overall universal approach. Does this translate outside of this trial and have a broader implication?
Yeah. I also am curious about that. The interesting thing here is that remember when you are using the CPIs, you are in a way, even if that is very, not, maybe not very scientific to say it that way, but you're in a way opening the tumor for the preexisting, immune system. In some patients, they will have a sufficient T-cell repertoire to kill off the tumor to push the patient into a complete response. In other patients, they do not have the sufficient number and quality of T-cells that can help them, into a complete response. Our thinking is that when you add a T-cell that can be, recognized tumors in all patients in the indication, telomerase is expressed, in all melanoma patients, for example.
We expect that the immune system will be relevant for more patients. Also in those patients with a low PDL-1 indicating to some extent that they have fewer relevant T-cells because then the tumor doesn't need to protect itself with PDL-1. Also in those patients, we see good efficacy when we add the vaccine on top. Remember that this is only a few patients, but we will follow up on this. In this indication and also in other indications. It would be very good if we could add a general vaccine on top of CPIs also have a possibility to treat this hard-to-treat patients in the future.
If I can just make an additional comment, you know. We, as we, you know, we inform all of you, we have this extension study to the INITIUM where, you know, we are going to be in a more controlled way, really make all these collection of samples to do a further examination. Of course, one of them is gonna be the PD-L1 expression. You know, as that study part, that extension study progresses and later in next year, you know, we will have a additional more data. We believe this is a very exciting finding.
You know, it's a small group of patients, but as Jens mentions, you know, shows that maybe patients that normally wouldn't respond to pembrolizumab, you know, would respond with the addition of UV1. This is more relevant in some other indications where the PD-L1 expression in reality defines which treatment the patients are gonna receive. Like, for instance, you know, in non-small cell lung cancer, if the patients are low expressers of PD-L1, they cannot just receive pembrolizumab alone. They have to add chemotherapy. This is, you know, areas where we see that as we collect more information, it can be very exciting to see if we can expand the pool of patients that will benefit of adding UV1 to the checkpoint inhibitor.
Thanks, Carlos and Jens. Next question. We have seen very good survival data. How long do you anticipate you will track this and how long do you believe the vaccine lasts in patients?
Well, as you know, we have conducted three phase I trials in the early days of the company's history. We follow those patients for the immune responses we induced in those patients, and we see immune responses after seven years. It doesn't mean that it stops at seven years, but we will continue to follow these patients. After seven years, the immune response T cells that can recognize telomerase are still there in the patients. We also follow these patients for overall survival up until 10 years, and we also follow long-time overall survival in the other clinical trials we are part of or conducting.
This is the most important endpoint, of course, that you can give the patients a long life, and this plateau, as we have discussed earlier in this presentation, is very important, and we would like to understand how this develops over the next years, in our trials.
Thanks, Jens. Moving on, we have a couple of questions related to the INITIUM trial. There are two quite similar questions, so you can probably cover both, Jens. The first one, INITIUM is often compared to CheckMate 067. Are there other and more recent studies that have come up with data for the nivo/ipi combination? Another slightly broader question, do you know of other comparable studies we should know of that can be of relevance to INITIUM?
The reason when you want to plan to start a randomized trial, you need to have some kind of idea how the drugs will work in patients. At the time we started to plan for the INITIUM trial, the CheckMate 067 trial was the relevant trial and still is for the combination of ipi/nivo treatment. This trial it was necessary to plan for the statistics in the INITIUM trial. Other than that, when the INITIUM trial has started, of course, treatment with the ipi and nivo may have developed over the last years. When doctors get more experience with the drugs, they become more aware of side effects that can occur, other treatment of patients can improve, et cetera.
We are not dependent on the results from the CheckMate 067 trial, where the median PFS is 11.5 months. We have, as we have discussed earlier, this so-called hazard ratio endpoint, so it's not important if the control arm is identical to what was seen in the CheckMate 067. It's the ratio between those two curves in the Kaplan-Meier plot that will be the endpoint in the INITIUM trial. When it comes to other trial, I guess the CheckMate 511 trial is very interesting, where they have flipped the dose with a lower dose of ipi and a high dose of nivolumab.
This is not an indication, and we do not have any knowledge that this will be an approved indication for the combination of ipi/nivo. Nevertheless, it's interesting results because the safety is lower when you have a lower dose of ipilimumab in that study.
Thanks, Jens. Another question related to INITIUM. Who registers relapses in melanoma slash in each, and how long does it take from patients have a relapse until this is registered in relevant systems?
I would not like to disclose the name, but it is a professional third party company that is working with this so-called independent re-review. What happens is that when the images are taken at the hospital, they will be sent to this third party, and they will be evaluated by radiologists in that company and scored. All the pictures from the hospitals will be sent, and the results obtained by this company are the numbers that will be used in the primary endpoint of the study. There is a third party collaborator that are looking at the pictures from the study, and they will score all of the pictures.
When 70 endpoints is reached, data and these pictures taken together, there will be a readout of the study. Of course, there is some lag in the system, meaning that it takes some time to transfer pictures from the local hospitals to the central institution. This is lag period that usually is very small. Also towards the end of a study, there are little difference between picture taken and a readout of the pictures by this third party collaborator.
I would like just to comment here because we get several times this question. I think there is some misunderstanding, you know. I would like to make it clear that we as a company, you know, it doesn't matter for the results, you know, how many events are so far. When the 70 events are reached, the contract research organization needs to clean up the data. We, you know, are not exposed to the results. When the CRO is ready and cleaned all the data, then they will say, Okay, we are ready to present the data to the company. That is the time where the company is exposed to the data.
We know at that time how many progressions are on each, in each arm. That's the time when shortly after this we will inform the market. Again, the important part is the number of progressions after we reach the 70 events. Again, only when the CRO has completed the cleanup of the data and all the images, then they inform the company about the results. To be clear, we don't know what the results are. Quite honestly, at the moment, no one knows because they have to collect the data, and this is only measured after the 70 events. It's just to be clear that the company will be exposed to the data, what were the results. Then at that time, you know, soon after that, we will inform the market.
Okay. Thanks. Moving on to DOVAC enrollment. We have had some different questions that are more or less the same, so I think it will be captured in the following, all of these. What is the primary reason for DOVAC involving patients at a slower pace than the rest of the phase II trials? You also mentioned that new centers have been activated during the Q3. Could we expect these centers starting to recruit patients during Q4? And related to this, we also have a questions: Have you implemented any initiatives to improve recruitment in DOVAC?
So during the pan-
Yes.
Yes. During the pandemic, we saw that, recruiting patients in already open trials, maybe I shouldn't use the word easy, but it was good. It was, we are happy with the enrollment of patients. It was more difficult to open new trials and open new sites, and this is due to negotiation around contracts, discussion about setup of the study at different hospitals, etc. Different hospitals had some different prioritizations during the COVID epidemic. This has changed over the summer and, during autumn. Several new sites are now open in this trial.
We have discussed this trial in different meetings with all the parties that participate in the study, and there is no competing standard of care that makes this study less attractive, even if it has recruited slower than we expected from the start. We do not see any issues related to that. We expect the enrollment of patients to increase over the next months. Also, maybe a bit technical, but when patients are in screening in this trial as of now. As you might remember from the inclusion in this study, the patients are on chemotherapy, and if they respond to that chemotherapy, they can be included in the study. When they are finished with the chemotherapy
Quite a few patients might have a response as of now, but they need to complete their chemotherapy treatment before they can be enrolled in the study. Therefore, it could take some time between screening of patients and actually enrollment in the study. We are on the ball here and discuss this with the investigators and all the parties in the study and expect this to go faster over the next period of time.
You know, again, I would like to make a comment here for clarification. You know, these studies, the DUVAC study and then some of the other studies, are what is called investigator-initiated studies. So we are not the ones responsible for running the clinical trial. We support, we provide UV1, but the coordination is done by these centers. This is totally different than the situation we had with INITIUM. In INITIUM, you know, and the team did a great job because, you know, we as a company could be in touch with investigators. You know, for instance, Jens and the clinical operations team, you know, a lot of times were on the phone with these centers, you know, at midnight because these were in the West Coast in the U.S.
As a company, that we are allowed to be in touch with the centers because it's our run study. In these type of studies like DUVAC, NIPU, you know, LUNGVAC, we as a company are not even allowed to be in touch with the investigators. As a company, we have a much limited scope of activities we can do to support. The only thing we do is, you know, we are in touch with the investigators, we offer our support, but in reality, we cannot be, we are not even allowed to be involved in the operations, the running of the study. This is the responsibility of the lead investigators and the lead centers. That we are clear in terms of the difference between these type of studies.
Yeah. Thanks. We have a question related to TET, and I guess this goes to you, Carlos. When will you inform more about the TET platform in the future? Will there be an UV2 in combination with the TET platform?
Well, you know, thanks for the question. You know, we get this several times, you know. Let me start by saying, you know, we have different projects going with TET, you know, in terms of CMC, preclinical is absolutely natural. But as I mentioned several times, we also have several patents, you know, being reviewed. We expect to be able to be more public and more, you know, tell more details about this during next year. This is gonna be dependent when the patents are granted, you know, when we have results from some of these studies that we are running at the moment. You know, we will definitely keep you informed, but will be some time during 2023.
you know, in terms of the question about which product, you know, at the moment, you know, we are collecting this data. Of course, we also have the TENDU study running. I think the great excitement, the potential is for TET, that the TET platform is that we can derive different products from this technology for our own pipeline, but also to enter into collaborations with other companies that require, you know, a quite innovative adjuvant technology. that is what TET is. It is a very innovative adjuvant technology, a very important component of any vaccine, you know.
Thanks, Carlos. I think this may be the last question today. Does your cash runway include a potential initiation of a phase III in melanoma and/or mesothelioma after INITIUM and NIPU? I'm happy to give a part of this answer, and then we should probably also put this into a strategic perspective. What are sort of the plans following phase II readouts? I can
Yeah.
Quickly address very specifically the cash runway. When we have the readout of the phase II trials, it will of course be important for the development UV1 to move quickly into preparing the next phase, activities such as assuming positive data, dialogue with regulatory authorities, preparing for a phase III trial. Of course, we have anticipated such activities in the cash runway we have guided on. There will be some significant activities related to that. It's very different though doing some preparatory activities compared to running the full trial because the cost is of course very different. Phase III trials, they have a significantly higher number of patients.
It's a very different story, a full funding of a phase II trial. That will need separate funding if that should be made, but this should be put into sort of a strategic context of how do we think about proceeding after the phase II readout. Maybe you, Carlos, would like to elaborate on that.
Sure. You know, again, to reinforce what Hans just said, you know, no. You know, the funding of a full phase III study, it's not. You know, these are totally different values, and I think we were clear about that. As Hans says, you know, what we will do is starting this preparation in terms of regulatory, CMC, and of course all the interactions with potential partners. You know, that also will value all these preparations that we'll be doing. You know, we will do as much as we can, and we'll be prepared, but no, you know, truly running a phase III study will require additional funding.
This will be, of course, if we need to raise capital to run a phase III, it's because we had positive phase II. You know, what is a totally different place to be, and this means of course that we had positive studies and will be a lot of excitement around the data.
Thank you, Carlos. There are no more questions today. Thanks for all the questions.
Okay. If that is the case, you know, I want again to thank Jens and Hans for being here presenting and of course to all of you for your support and for taking the time to listen to us. Again, you know, you can send any questions to Anne, our investor relations director, that will be then happy to answer as many as possible. Again, thank you everybody, and have a good rest of the day.