Good afternoon, everybody, Welcome to Ultimovacs Fourth Quarter 2022 results. As usual, I have with me our Chief Medical Officer, Jens Bjørheim, and our Chief Financial Officer, Hans Vassgård Eid. We have received a lot of questions, but feel free to, while we present, to send your questions as usual to the links that you have received with the details of the webcast. With this, let's move to the next slides. We have to show you this, but let's talk about Q4 2022 highlights. Again, a very busy but successful quarter for Ultimovacs and the team.
I think, the news that everybody is waiting is, of course, are we as a company on track and prepared for the readouts that we're gonna have during the first half of 2023 in the first two of our five phase II studies with universal cancer vaccine UV1. I can tell you, yes, we are on track, and we are prepared for these potential key value inflection points that we are expecting during the first half of 2023. The top-line results, we will inform you know, very, very soon after we receive these results from the contract research organizations. You know, just stay with us, and we will continue to keep you informed.
I would like to emphasize again, as previously communicated, that we will not be providing any more details about these studies until we have the data, and we will give you the details at that time. Stay tuned. Overall, we have a very good progress in our clinical program. You know, we are very happy that we completed a patient enrollment also very recently in the NIPU study, but also at the end of the quarter in the TENDU study. We are also very pleased that recruitment continues to progress with the other studies.
As you know, we had some delays that were primarily during the initial phases of these studies where we had this administrative process with the health authorities and the ethical committees, different hospital centers that, for instance, in the DOVACC are quite complex because, as you know, we have more than 40 centers in 10 countries, so that takes a long time. We are very happy that now, as you could see, where the patient enrollment is picking up. LUNGVAC also, you know, due to the changes in the reimbursement of standard of care by the Norwegian authorities that moved from pembrolizumab to cemiplimab, you know, we had to, the centers had to adapt. As a company, the protocol was already basically flexible enough to anticipate this potential change.
Of course, the centers are now to adapt, and they are doing it, and we are pleased hat the first two patients with cemiplimab were also enrolled. Very exciting that has been happening in the last months. One of them, and I will talk a little bit about that, is now the renewed interest and the buzz around cancer vaccines, what we see quite positively. Part of it is because some of the news you saw of the agreement between Moderna and MSD. Also in general, we see and hear a lot more interest for cancer vaccines. What, of course, we believe is very positive for Ultimovacs.
We also extended our runway to the mid of 2024, what is a good place to be for us as a company, being funded during these volatile times while we basically expect all these results to come through. We received a lot of questions, you know, around endpoints. What is the difference between primary endpoints, secondary endpoints? What do they mean? Jens will have a couple of slides on these specific topics.
We also receive a lot of questions about, you know, what is the process, what is the normal process from when companies are informed about the number of endpoints, basically when the database for the clinical study is locked and the sponsor received the data to clean the process, what we call clean the data, until the information is provided to the sponsor. There is a period of time that is very variable, and Jens will also cover this. You know, there is a little bit more of clarity around what does it mean, how long does it take. There are, of course, different periods of time depending on the studies, and Jens will cover that.
You know, we will be talking in more detail about the operations, the financials by Hans, but we will also be addressing some of your questions and then talking a little bit about the next stage and next phase for Ultimovacs. With this, I give the word to Jens, and moving to the next slide.
Thank you, Carlos, and good afternoon to everyone. In this part of the presentation, as Carlos said, we will touch upon some of the questions that have arrived, and there are some background slides for the vaccine, as usual. Then we will also present the data, and some of you at least have seen before, and a short discussion around this cleanup period after you have the endpoints in a study. If you can move to the next slide, Hans. This one is the one you have seen several times before, showing the clinical development program ongoing in Ultimovacs as of today.
The upper three lines represent our sponsored indication, Malignant melanoma, where we have three completed trials as of now, and we are waiting for the readout in the phase II trial first half of this year. As we have said earlier, there has been a lot of interest around the UV1 vaccine to combine that with different checkpoints in different indications. As you know, we are part of four other phase II trials: one in pleural mesothelioma, one in head and neck cancer, one in ovarian cancer, and latest now, one in non-small cell lung cancer. The common denominator for all these trials is that the patients with these indications express Telomerase, which is our antigen for the vaccine.
If you move on to the next slide, we will go into the numbers for recruitment in the different trials. As you know, both the INITIUM and NIPU trials are completed and with expected readout first half of this year. In the FOCUS trial in head and neck cancer, that is metastatic or recurrent head and neck cancer where we combine with pembrolizumab, 50 out of 75 or two-thirds of the patients are now enrolled in the study. Expected readout of this trial is the first half of 2024, changed from 2023 earlier. The DOVACC trial is in ovarian cancer patients, women that are BRCA negative that respond to chemotherapy as second line treatment.
In this trial, inclusion has gained some speed lately, and we have now 17 out of 184 patients included in study versus seven at last report. Expected readout in this trial is second half of 2024. The LUNGVAC study in non-small cell lung cancer patients with PD-L1 expression 50% or above and without the mutations. In this trial, two patients have been included with cemiplimab. Earlier, we included three patients with pembrolizumab before the change of reimbursed drug to this patient group in Norway happened last autumn. Expected readout, second half of 2025. For the other program we are developing, the TET platform, the TENDU trial in prostate cancer patients.
All patients have been recruited to the study. We expect a readout in this study second half of this year. If you move on to the next slide, I will say a few words regarding the vaccine as such, because discussing the antigen is important to get also the understanding of the general aspects of this, of the UV1 vaccine. For normal tissue to develop into cancer tissue, there need to be different changes or mutations in place that leads to the development of a tumor cell. One of these features is that cell need to have the opportunity to have eternal cell division. It can continue to divide in theory forever.
One of the strategies cells use to come into this position is to activate an enzyme called Telomerase. Telomerase is activated in 85% to 90% of all cancer indications, and it's something that happens early on in the development of the cancer. You can see it from early stage one and throughout the course of the cancer. The Telomerase activation is also an essential thing to the tumor. It's something that happens early and followed all parts of the tumor. If you look at the different parts of the tumor, like the primary and the metastasis, you will see expression of the Telomerase. By this, you can say that the Telomerase antigen is a general and relevant antigen in all parts of the tumor and through the different stages of a tumor development.
Moving on to the results from the second phase I trial that was presented at the SMR Congress in Edinburgh last autumn in November. This study is a study with the UV1 vaccine in combination with pembrolizumab in first-line treatment of patients with a Metastatic melanoma. As you know from earlier, the median PFS has read out in this trial at 18.9 months, and we have followed the patients for two years. After one year, the overall survival was 86% versus 73% after two years of observation. On the next slide, you can also see how the responses in these patients developed through the course of this study. Each line here represent a patient, and each box represent an image of the patient.
There is also two stippled lines, and the lower one, -30%, represent the level where you say that the patient has a partial response, meaning that parts of the tumor is gone. A complete response is when all signs of the tumor has disappeared. We followed these patients for two years, as I said, and we see that after one year, 94% of all the patients that had a partial or complete response, they remain in such response after one year. Moving on to the next slide, the same patients presented in a waterfall plot. Here you can see that each column represent a patient, and you can also see the stage of the cancer in each patient. Also there is information about different biomarkers that are used when you treat or not used.
You don't need to use them in melanoma, but they are investigated by the researchers because if you have different levels of different biomarkers, it might indicate that you have a different response to treatment. In our study with 30 patients, 10 of the patients had a complete response, and seven had a partial response. We also did this biomarker analysis of the patients, like tumor mutation burden and PD-L1 status. What we saw in this trial was that when patients were PD-L1 negative and the same observation complete response rate and response rate was observed in that group. In the box below the waterfall plot, you can see historical data from the KEYNOTE-006 trial.
The numbers to the left represent the whole group of patients with a response rate between 34% and 42% and a complete response rate between 5% and 14%. To the right, you can see the response rate in those patients that are PD-L1 negative, 24.3%, and complete responders, 5.8%. In our small trial with 30 patients, we did not see this difference. Also in the patients with a PD-L1 negative status, the frequency of response was the same as in the whole study altogether. Moving on to the next slide is a picture of the two trials that are now fully enrolled. The INITIUM trial to the left where we have combined Nivo/Ipi plus/ minus the vaccine on top. In this trial, 156 patients are included.
The NIPU trial to the right, this is second-line pleural metastatic mesothelioma patients. Nivolumab, Ipilimumab plus/ minus the vaccine on top, and 118 patients are recruited. As we have discussed earlier, both this trial has a so-called endpoint driven design, meaning that we are waiting for 70 endpoints. What we are waiting for is this progression-free survival. Progression-free survival as such is an endpoint that have two components. The one component is progression of the tumor, meaning that the tumor is growing, and the other component is death. The combination of these two events make up the progression-free survival endpoint. The whole statistics in such trials like this are designed around the primary endpoint.
There is a connection between the number of patients that needs to be included, the number of endpoints you need to reach, and the statistics in the study that gives you an answer to the progression-free survival, if that is different between the two arms or identical. Then we have something called secondary endpoints, like overall survival, objective response rate, duration of response, and safety. For the secondary endpoints in a trial like this, the trial is not designed statistically to give the same kind of statistics as you have with the primary endpoint. Upon, for example, a positive study, meaning that you have a positive primary endpoint, the secondary endpoints will be supportive information that you can use in your further development of a medical product.
We can see that in the next slide, but first before we move there, I just want to say a few words about safety as well. Safety is also very important. As you might know, with the CPIs, there has been a lot of safety events within the field of autoimmunity, that the immune system gets supported so much that it start to attack different tissues in your own body. When we are here combining with these two checkpoint inhibitors, it's very important that we do have a safety profile of the third component, the UV1 vaccine, that doesn't harm the safety profile further. This is also important so that the patients are kept on the treatment with the checkpoint inhibitors, in this case, nivolumab and ipilimumab. Back to the endpoints and progression-free survival versus overall survival.
If we look at the next slide here, for all patients with a cancer, of course, the gold standard and also for the medical community, overall survival is the gold standard. You want to help the patients, so they survive their cancer. In some indications, and if you treat in an early line, it will be in some indications several years until patients eventually die from the disease. To be in a position where you can do clinical trials that have goes over a relevant number of years, not take too long, so-called surrogate endpoints are developed. One of these endpoints are PFS. So for when you develop the drug, it's important to understand how the PFS, for example, associates or correlates with the overall survival in the end. We have an example of that here to the right.
In the upper part of this figure, you can see the progression-free survival of the control arm, in red and the intervention arm in blue from the registration study of ipilimumab and nivolumab in mesothelioma. The red line represent chemotherapy, which was the control arm and standard of care for these patients at the time study was conducted. The blue arm represent the patients that received nivolumab and ipilimumab. If you look at the I axis in the upper part of this figure at 50% and take a line horizontally out there, you will see actually at 50%, which represents the median PFS. The median PFS was better with chemotherapy as compared with the ipi and nivolumab.
Thereafter, if you go to the lower part of this figure, you can see that if here in the overall survival readout, the CPIs ipilimumab and nivolumab actually had a better overall survival than the chemotherapy group. If you select a trial and your final endpoint was progression-free survival only, and you conclude on that without having additional secondary endpoint information to look at, you might conclude that the upper picture here concludes that the study is a negative one. If you look further to overall survival in this case was also an endpoint in this study, you can see that there is actually an overall survival benefit in this study. It's important to understand the association between surrogate endpoints and overall survival in the end.
Moving on to the next slide, a few comments regarding the cleaning process of data from clinical trials. In our trials, we have some so-called central review of the images. This means that there is a third party that is evaluating the CT scans from the patients before the data are entered into the data file or the eCRF. To get the pictures from the hospital to the central review takes time and also the review itself. It also need to be verified that everything around the scanned scan is in place, like correct dates, et cetera. All slides are sent to this third party vendor.
This takes time, and it also some kind of backlog because all the slides come through a central institution that will read the slides if something is missing, some information is missing, there will be a question regarding that that needs to be solved before the conclusion on each individual scan can be taken. Also, after you have the endpoints reached in a study, there will be all the sites which participate in the clinical trial will be monitored by the CRO. All the databases that are connected or used in the trial needs to be compiled or put together. You have the full data picture from individual parts of the study, like laboratory imaging, clinical evaluation, et cetera.
Before you go on to the statistical analysis of the data, in your database, you also need to have all queries solved. All data, all missing data should be there and verified before you are going into the statistics. Thereafter the statistics is performed in the initial trial. It's performed according to a predefined statistical analysis plan, meaning that prior to inclusion of... there is already now a set of tables, figures, and listings that will in a way be populated with the data from the study. Thereafter, when the statistics is conducted and checked and reviewed, the top-line data can be communicated to the sponsor of the study.
Based on the complexity of different studies, like few centers, many centers, few countries, many countries, et cetera, this process can take from a few weeks up to a couple of months in different studies. If you move on to the next slide, just a very short update on the TET platform. The TENDU phase I trial in prostate cancer patients. This is the first trial where we evaluate the TET adjuvant technology. As you know, this trial is fully enrolled. All patients were enrolled at the Oslo University Hospital, and we expect readout from this study's second half of 2023. This is the first trial where we have this new asset.
The endpoints in this trial is to have some initial understanding of the safety, the immune responses generated with this new molecule, and also a better understanding of the doses we need to use moving forward with this platform technology. As of today, there is no safety concerns seen in this trial.
Moving on to the next slide, we will, also move on to the next presenter. Please, Hans.
Thank you, Jens. I'm happy to go through the key financial elements from this report. When we now report from the Q4 2022 period, we do see a certain increase in operating expenses. That is as expected, and also as previously guided. Looking at the full financial year 2022, we had operating expenses in total of NOK 184 million, and that is a 12% increase from 2021. It reflects a general increased activity level. It's fair to say that the increase in R&D costs has actually been lower than we have indicated earlier. This is due to some of these delays that we have spoken about in clinical trials, like DOVACC and LUNGVAC. The startup time has been somewhat longer.
It means that some of these costs will come later than we have assumed. If we look specifically at the fourth quarter 2022 and compare that with the same period in 2021, we see a higher increase of actually 42% from NOK 51 million to NOK 72 million. That's percentage-wise quite a big increase, but it's driven mainly by share option expenses and related social security tax accruals, and this fluctuates with the company share price. The difference is quite big, NOK 17 million higher in Q4 2022 than in Q4 2021. There are also some significant non-cash cost elements in this that I will come back to when we look at the cash flow in a slide later on.
If we look at the cash position at the end of Q4 2022, we had a total cash position of NOK 425 million or around $42 million. That gives an expected financial runway to mid-2024. This is an extension of the guidance we have given earlier when we have indicated that we have cash until the first half of 2024. We see that we, as mentioned, have some delays in R&D costs, so they will come somewhat later. We also have some cost savings that we can capture. Based on this, we are able to guide on an extended financial runway to mid-2024.
Going forward, we should expect the operating expense level to be higher than we have seen so far, but we will clearly continue to see quarterly variations. As I've said several times before, it's easier to estimate in these large R&D projects and the total cost than actually the exact timing of the cost. The increase is driven by further progress in the phase II trials, further development in the CMC area, which is the manufacturing development, and also other R&D activities. Move on to look a little bit more into detail on the different operating expense elements and also the net financial items. The payroll expenses, looking at Q4 2022 versus Q4 2021, the regular salary costs were approximately at the same level.
As I said, there has been a significant increase in the total payroll expenses due to these share opt-option costs. In fact, in Q4 2021, there was a reversal of such costs, so a negative number. Whereas we had some significant costs here in Q4 2022 with the increasing share price. The difference is actually quite big looking at Q4 2022 to versus Q4 2021. If we look at the full year payroll costs, the regular salary costs were somewhat higher, with two more FTEs added during the year. The share opt-option costs for the full year were also slightly higher in 2022 than in 2021. Moving on to the R&D expenses.
The R&D costs were approximately at the same level in Q4 2022 versus Q4 2021, the same goes when for the full year comparison. For other operating expenses, we do see higher expenses reflecting a higher activity level. We are preparing actively for the readouts from the phase II trials. We do spend more time on traveling. Coming out of the pandemic, we spend more time on business development and different activities related to the readouts and activities thereafter. It implies a certain increase in these costs. Looking at the net financial items, we also have quite a significant income element in the full year 2022 of NOK 15 million or NOK 16 million .
That is comprised of interest income of NOK 9 million, and also net foreign exchange gain of NOK 7 million from some of the hedging positions we have in Euros. Okay. I will move quickly to the cash flow overview. We have seen an increased negative cash flow during the last quarters. In Q4 specifically, there is quite a significant deviation between the negative operating cash flow and the operating expenses. As mentioned, the operating expenses were around NOK 70 million, due to some significant non-cash elements related to the option scheme and also some year-end accruals, the net operating cash flow is - NOK 50 million compared to the NOK 70 million expense level. Yes.
We have also this time included a more detailed quarter by quarter overview of the key financials, so that that may help those of you wanting to dig a little bit more into the details of the cost development. With that, I give the word back to Carlos for the last section.
Thanks, Jens, and thanks, Hans. If we move to the next slide. As I mentioned, cancer vaccines are now on the agenda. You know, what is very rewarding, because as you know, has not been the case for many years. It's good for the patients, it's good for the space, and of course is good for Ultimovacs. As you see there now the... And it's circled, more effective cancer vaccines are now one of the hot topics in immunotherapy in 2023 by, you know, selected by the American Association for Cancer Research. Cancer vaccines, the next immunotherapy frontier from Nature Cancer. Cancer vaccines, what's hot in 2023. Hot, hot. We also have some publications.
Clearly this is ideal time for Ultimovacs to come out with data that of course we all hope for the benefit of patients that is positive, because means that the space is more aware and more open to listen to this data. To help them, you know, really hear about Ultimovacs, a small biotech from a small country in the north of Europe. In the next slide, you see that we are quite busy spreading the word. You know, since the beginning of the year, we have been participating in different conferences, presenting the company. We are participating in different panels. We have been invited by banking conferences to present what is very rewarding.
From a perspective of medical, where we will also be participating in several conferences, investor conferences, business development conferences. You see here that the first half of the year is quite a busy period for the team. That, of course we try to maximize, as I mentioned, raising awareness of Ultimovacs and what we are doing and in anticipation of a positive data. Very important to spread the message. You know, at the moment, as you can imagine, we are relatively well-known in Norway and in the Nordic countries. We are focusing more in the rest of Europe, and in the U.S. Of course, you know, we haven't forgotten you, and we are planning when the activities will slow down a little bit to also do some more of these meet the team events.
If we move to the next slide. You see here basically that, the excitement that we are all having have, as receiving the data from the CROs and informing you very soon after that happens. As I said, we maintain the guidance for the time being that, both INITIUM and NIPU top-line results will be available during the first half of 2023. As I mentioned, you know, that will be the next update that you have on the data for these two studies. We will, after this, assuming positive data, we will have a series of plans in place that then will have to be executed from, regulatory activities, investor activities, partnering activities. The team is again, continue to be very excited and busy, for the anticipated future, again, assuming positive data.
Of course, we are not just INITIUM and NIPU. It's rewarding to see that now we are again continue to have enrollment of patients in the other clinical programs, you know, and FOCUS is, you know, slightly delayed up to six months. We, as you see, you know, continues to enroll patients. As I mentioned, very pleased that DOVACC is catching up and the LUNGVAC, you know, very important studies, but also showing that as a company, you know, we are not just a one-trick pony. We have different data points and potentially significant events coming not only very soon, but also in the next six to 30 months. Of course, we shouldn't forget about our TET, vaccine adjuvant technology, and the TENDU study.
We are doing several non-clinical and CMC production activities. You know, we will be keeping you informed and give you more details about this program later in the year. Let's move to the next slide. I think, you know, doing a wrap up of this webcast and the quarter. Very successful as we completed enrollment in three of the studies despite the challenge of the pandemic. You know that, you know, it's been a big effort from the team to deliver this. The fact that, you know, we are on track to the expected top-line readouts during the first half of the year for INITIUM and NIPU.
That, you know, we, in anticipation of positive results as a team and as a company, we have different activities planned to be activated if the data is positive. The fact that, you know, the space is being now recognized as more important. In the cancer vaccine space, we believe that we are very well-positioned in this emerging cancer vaccine landscape due to different factors, you know. One is the fact that we call it as we believe UV1 is a universal vaccine. We classify it as universal because it's a universal target that can be used across multiple cancer indications. The fact that we don't need to do any screening of patients, we can be used right away, it's also quite universal.
The fact that, you know, the universal usage of the vaccine because we can be used from early stages to late stages of the cancer. Other very important benefits that for the ones that are now more familiar with vaccines and some of the challenges of some of the COVID vaccines, the fact that we are a truly off-the-shelf product just kept in the normal fridge, ready to be administered when needed. The fact that, you know, there are simple logistics. You know, we don't need any complex infrastructures to administer the vaccine. We don't need very complex cold chain distribution to send the UV1 around. The fact also that it's easy to use as intradermal injections. We don't need to do biopsies. We don't need to have access direct to the tumor.
I think it's important, and it's a key topic that is now more and more, is access. We need to facilitate access of medication, in this case UV1, to patients. We think that we have several important characteristics that facilitate the access of patients to UV1. Also, you know, the exciting part, not only of the cancer landscape, but also we have received a lot of attention and comments from this exciting data regarding the biomarker analysis because it has been one of the challenges. If the patients have a low expression of PD-L1, you know, treatment with CPIs is not most effective. There is an enthusiasm of exploring more the results that we have found in our UV1-103 study.
You know, for the ones with you that are also more close to the sector and the challenge that is happening overall in the biotech, not only in Europe but also particularly in the U.S., the volatility, and how difficult that is to raise cash during these times. We are very pleased that not only we are solidly financial, we have a solid group of key owners, but we were able also through discipline and also, of course, some of these allies in the groups that we were able to extend the runway to mid-2024, what is very, very good for us as a company. With this, I want to again thank you for all your time, your attention, and we can move now to the Q&A part of this webcast.
Thank you, Carlos. I will take us through the questions we have received. We have received also this time quite a few questions related to the process in INITIUM and NIPU towards the readout. Jens addressed that in quite some detail today, so that should be well covered based on Jens' presentation. I think these questions were mainly posted before Jens shared these perspectives, so I will not repeat those questions because they should be well covered. The first question is: "When will the vaccine be available to everyone?
Excellent question. You know, of course, we want it to be available as soon as possible but, you know, we need to understand that there are very, you know, clear processes and regulations on how to develop the vaccine. What we can assure you is that as a company and as a team, we are doing our best not to waste any time in the development and the activities. Then it's gonna really be depending on, you know, is it gonna be the normal timelines? Is the data going to be so positive that we may explore and discuss with the authorities for what we call a conditional Accelerated Approval in specific indications. A very, very difficult to give you a precise timeline. A lot of factors are around it.
I can assure you that as a team, we have been dedicating our time and investments to make sure that these timelines are as fast as possible.
Thank you, Carlos. Next question. "Is there a possibility that the readout in INITIUM and/or NIPU will come first in the third quarter of this year?
Well, you know, we're at the only thing we can answer to that is maintaining for the time being the, you know, the guidance that we have promised. I repeat again. We expect top-line results in the, in the first half of 2023. Any changes, you know, we will inform the market.
Thank you. next question related to TENDU. In TENDU, the enrollment of all 12 patients is completed, but readout is expected in the second half of 2023. Why is the readout taking so long time for so few patients?
Yes. In the TENDU trial, in that study, we vaccinated 12 patients, three different dose levels, and one of the endpoints in that trial is immune responses from the vaccination. The vaccination, the immune response towards the vaccination will be followed for a certain time for each patient. Even if a patient was enrolled a short period back, we will follow the immune responses in such patients for a bit longer time over months. In that sense, even if the patients are there now, we need also to follow the patients for a while before we have a complete data set.
Thank you, Jens. We have a question on safety that, we probably can't answer too much, but I leave that to you, Jens. Can you comment on the blinded adverse events that you are seeing reported? For example, are there notably more in the CPI combo studies?
Regarding safety from the phase II trials, that needs to be reported when we have the data. From the Phase I trials, in general, we have seen that most safety that we see is linked to the CPIs. For example, in the UV1-103 trial, the safety profile has been characterized as expected for pembrolizumab alone, except for injection site reactions on top. Also remember that all data from the Phase I trials with melanoma has been reviewed by the FDA, and we received back this Fast Track designation for the both combinations and also Orphan Drug Designation. That also means that the authorities have looked into the data in these trials.
Third, but also important is that we have been allowed to start studies in new indications, directly in phase II with new CPI and the vaccine combinations without having safety run-ins, et cetera, prior to start up. Safety in general has not stopped us conducting trials this far in the development, and we are very happy for that, both for the patients and the development of the vaccine.
Thanks, Jens. A question probably to Carlos: How is the pricing strategy for UV1?
Well, you know, the pricing strategy, as you can imagine, is not yet defined. You know, if you want to have some ideas, you can look at the analyst reports. They make their assumptions, you know. For us as a company, you know, pricing is always gonna be dependent on the how strong is the data, what is gonna be the market situation. Ultimately, you know, we have been public about that, you know, that if we license out UV1 to a strategic partner, that is gonna be defined by the company that will take ownership of continue to develop and commercialize UV1.
Thanks, Carlos. A patent question. We understand that last year you received a notice of allowance from the USPTO, which should help you extend the UV1 patent to 2037. What is the latest status on that?
That patent is granted, and we continue to pursue the same in other regions. The team and the external advisors are very busy pursuing not only those ones, but continuously looking for opportunities to file new patents, what we are doing, and extending the patent situation not only for UV1, but also for overall the TAT platform and product. As everybody knows, IP patents is very important, very important for a company, for a biotech, and we put the efforts and the dedication to really expand as much as we can the IP portfolio that is in the company.
Thank you. We have re-received a couple of questions related to the Merck Moderna results. We can take them in combination. One question is: What are your thoughts about the Merck Moderna results in the KEYNOTE-942 trial, and how does the Moderna readout impact interest for cancer vaccines more broadly? I'd like to add to that another question. Could you provide us somewhat some details on how UV1 potentially differentiates from the mRNA vaccine used in the Merck Moderna study?
Yeah. Maybe I can address the first ones. You know, I think the clearly the results and primarily the deal between Moderna and Merck has been as I mentioned definitely raising awareness and the interest for cancer vaccines. We see that as very positive. The data, you know, even mentioned by both Moderna and MSD, you know, is still not fully mature. Most probably we are gonna hear more details of the data in a medical conference, you know, soon.
I think it's better to wait for that because they also mentioned that, you know, it's not mature enough and, you know, Jens can give you a couple of more comments on that, but also address the latest question between the difference between mRNA vaccines and UV1. Also, you know, of course, these are totally different indications. The ones that they are using in adjuvant setting versus ours advanced setting, but also the fact that we are universal vaccine, they are a personalized vaccine. There are basic differences, but I think that Jens can complement this with a little bit more information.
Yeah. Thank you, Carlos. Remember that the only molecules that are presented to the immune system are peptides. The antigen-presenting cells present peptides to the immune system, which can lead to activation of the immune system. It is, of course, different ways of delivering the sequences that we want the immune system to react to. You can do it as a peptide, mRNA, DNA. We have selected to use the peptides, so we have, in a way, a direct control over the dosing we give to the patient, and we are not dependent on any intra body metabolism to produce the peptides. Having that said, it's likely if the concept of vaccines works, it's likely that different modalities can trigger such immune responses.
In general, we are welcoming all kind of methodology that will lead to relevant immune activation for patients. One aspect that might be tougher with the vaccines that are individualized or personalized vaccines is that the production time. I guess they have a lot of plans how to reduce that, but it's quite long today. I say this in the context that we see that the clinical field development of checkpoint inhibitors and immune therapy is now moving earlier. For example, if you want to do a neoadjuvant treatment of patients, that means that you give the patients a medical treatment prior to an operation. You have a few weeks there before you need to operate the patient.
It is evidence that, if you give drugs, medication to such patients, it might be easier to operate. The neoadjuvant field is gaining a lot of attention these days. With our vaccine, which is an off-the-shelf vaccine, we can directly vaccinate these patients without any delay. With some other assets, you need weeks of development before the vaccine is ready to give to the patient, and that might be too long as of now. We welcome different methodologies to the field and do hope that there will be more than one opportunity for the doctors to select vaccination of patients. We need this field to not only be a few companies but to develop, so it's improving over the years.
Okay. Thank you, Jens and Carlos. There are no further questions.
Right. Thank you, Jens. Thank you, Hans. Of course, thank you all of you that participated for your questions and attended this webcast. Again, we are entering very exciting periods, and we hope that you follow us and you walk with us because we are all in the company outside, but also in the world, hopeful that we will get positive data because that will be very important for cancer vaccines and of course, ultimately for cancer patients that need as many alternatives as available to them and to help them extend and survive for a longer period of times. Thank you everybody, and have a good rest of the day.