Ultimovacs ASA

OSE:ULTI

Earnings Call Transcript

[Carlos de Sousa, Chief Executive Officer]

Good morning, everybody, and welcome to Ultimovacs Fourth Quarter 2020 presentation. Thank you for being here and for your interest in listening to what was a very successful quarter for Ultimovacs. So let's move to the next slide, Slide #2. I need to show you the disclaimer. And now moving to Slide #3. This is the agenda for today. I will start giving the highlights for the quarter. Then I will give the word to Jens to go through the operational update on our clinical trials. Hans will cover the key financials and news flow. And then we will have, as usually, we select a theme to explain and talk to our shareholders about some of the key topics that impact our activities in our industry. And we selected for this quarter talking about intellectual property rights and other ways of protecting the commercial interest of the company. And as usual, we will end with a Q&A session. So please make sure that you start sending your questions now through the link. Moving to the next slide, Slide #4. So highlights for the fourth quarter. As I mentioned, this was a exceptional quarter for Ultimovacs. We extended our Phase II program from 2 studies to 4 studies. And in these 4 studies, we are going to have more than 500 patients enrolled. What is a very good number and a very ambitious number for a small biotech like us. And these 2 studies are very important DOVACC trial, that is a collaboration with the Nordic Society, of Gynaecological Oncology, the European Network for Gynaecological Oncological Trials (sic) [ European Network for Gynaecological Oncological Trial Groups ] and AstraZeneca and will enroll 184 patients. And Jens will give more details on this on these studies. The FOCUS trial, the second trial that we have announced is a collaboration with University Medicine Halle, in Germany in head and neck cancer and will enroll 75 patients. Moving to the next slide, Slide #5. Also during this quarter, we announced 5-year survival on the ongoing -- sorry, we announced the update of the recruitment in INITIUM and NIPU trials. So very happy that despite all the challenges caused by the COVID-19, we were able during this quarter to add 12 additional patients to the INITIUM trial so we have now 24 patients enrolled, and additional 13 patients enrolled in the NIPU trial. So this is despite, as I mentioned, the fact that the COVID-19 is impacting all of us. Society, individuals and companies in doing their business, of course, this quarter was also a quarter with a lot of time linked also to the holidays. But despite this, we continue to recruit patients. So as a company, the only thing we can do in this environment is to really actively monitor the COVID-19 pandemic regarding how we enroll patients in our clinical trials, and we continue to implement activities to try to minimize that impact. And long-term, and the rest of the year, my guess is as good as yours. We need to see how the rollout of the vaccines will impact lockdown in the general biotech industry and the pharma and society in general. So again, what I wanted to assure you here is that we actively monitor the situation. And we are flexible and adapt to make sure that we try to minimize the impact. So when we move to the next slide, as I mentioned earlier, we also reported a readout of the 5-year overall survival in 2 of our Phase I trials, the non-small cell lung cancer and metastatic melanoma. And in these trials, we continue to confirm the safety of UV1 and also the encouraging signals of long-term survival effect. As we have been mentioning several times, you know that our strategy is to -- is after Phase II results, to look for a strategic partner that can maximize the potential of UV1 and bring UV1 to the market in a series of indications. Of course, as a company, we are also prepared to go along if that is required. But in order to optimize and maximize and amplify these activities with potential partners, we're very pleased to have recruited Ton Berkien as Chief Business Officer, he just joined the company in December. So Ton is a experienced as business developer, and then he will focus primarily in making sure that UV1 and Ultimovacs is well known within the potential partner community, the pharmas. And also that we maintain regular contacts with these companies to make sure that they are aware of all of our developments. We then move to the next slide. Also, as we mentioned, we have different objectives in terms of raising awareness of Ultimovacs among different communities, the investor community, the pharma community, but also the scientific community, where we already have a very, very important presence and a lot of interest from key opinion leaders and different oncology groups. And that is also achieved by having papers published on results. So we already -- also pleased that in the fourth quarter, we had another presentation in the Frontiers in Immunology on the long-term follow-up data from UV1 Phase I trial in non-small cell lung cancer. As a small biotech, we are, of course, relying on the support from our shareholders, but also when possible from society in general, particularly from institutions, that have an interest in supporting the scientific and clinical activities that we have. So we were also very pleased that with the significant grants obtained for supporting our Phase II trials, the DOVACC and FOCUS trial. And this is a total up to NOK 26 million and were obtained from Innovation Norway and from Norwegian Research Council. So this is, again, is very rewarding for us to -- as a recognition of the potential impact we may have in cancer patients. But also recognition that what we have been doing and showing in terms of results is also recognized by these institutions. So we are very pleased with this significant contribution from these institutions. If we move to the next slide, we are moving now to the operational update, and I'm going to give the word to Jens.

[Jens Egil Torbjørn Bjørheim, Chief Medical Officer]

And also, good morning. We are now on Slide #9. This slide presents the clinical studies in Ultimovacs. As you can see, we have conducted 3 Phase I trials that are finished, and we have 1 ongoing. Further, as Carlos mentioned, we also have started 2 Phase II trials last year. And there will be 2 new Phase II trials that will start to include patients this year. I will come back to all of these trials. Further, we also have the TET-platform. TET program has been in the preclinical setting up until now. Early this year, we will start a clinical trial in prostate cancer, as we have informed about earlier. If you go to the next slide. On this slide, you can see the 2 Phase II trials that have not started to include patients yet. To do that is the DOVACC trial that is a trial that will be conducted in second-line maintenance in ovarian cancer patients. That means that after the patients have received 2 rounds of chemotherapy, and if they have effect from the second round of chemotherapy, they can be included in this trial. Also, the patients that will be included in this trial is so-called BRCA negative patients. This is a trial that is sponsored by NSGO and ENGOT, the umbrella organization in Europe and they collaborate with AstraZeneca and ourselves to conduct this trial. 184 patients will be included from approximately 10 European countries and in more than 40 hospitals or sites across Europe. The study has 3 arms. In all arms, the patients will receive the standard treatment olaparib. In the B arm on top, they will also receive durvalumab, which is a PD-L1 antibody. And in the third arm, they will also receive the vaccine on top. The statistics is between Arm A, olaparib and arm C, the triple combination. PFS, progression-free survival is the primary endpoint in this trial. And expected readout is in 2023. The second Phase II trial on this slide, the FOCUS trial is a trial in head and neck cancer, in patients that are PD-L1 positive when it comes to expression and that has metastatic or recurrent head and neck cancer. This is a purely German trial. It's sponsored by Halle University Hospital outside of Berlin and totaling 10 centers in Germany participate in this trial. In both arms of this trial, the patients will receive pembrolizumab. And in the intervention arm, UV1 on top. PFS is also the endpoint in this trial, that is so-called landmark endpoint, and the readout will be after 6 months. If you move to the next slide. So this is a slide presenting the 2 trials that have already started to include patients. First, the INITIUM trial. That is the Ultimovacs-sponsored randomized Phase II trial in first-line malignant melanoma patients, where patients in both arms receive nivolumab and ipilimumab and in the intervention arm also UV1 on top. Totally, 154 patients will be included in this trial, in around 40 sites in Norway, Belgium, U.K. and U.S. The trial started to enroll patients in June last year. And as of 16th of February this year, 24 patients are included in this trial. Top line results from the trial is expected in second half of 2022, and PFS, progression-free survival is also, here, the endpoint. The NIPU trial is a trial sponsored by Oslo University Hospital. They collaborate with the BMS and Ultimovacs and the indication is malignant pleural mesothelioma, second-line patients. These patients then receive chemotherapy as first line. And when they progress, they can be included in this trial. The study is conducted in the Scandinavian countries, in Spain and in Australia, and totally, 118 patients will be included. Inclusion started in June last year. And as of 16th of February, 18 patients is included. In this trial, also the patients who receive the same treatment regime as in the INITIUM trial with nivolumab and ipilimumab and in the intervention arm, UV1 on top. Endpoint in the trial is PFS. On Slide 12, you can see the results from the first 3 Phase I trials we conducted. We conducted 3 Phase I trials at the Radium Hospital, 1 in prostate cancer, 1 in non-small cell lung cancer, those 2 trials, were as monotherapy. And the third trial in malignant melanoma in combination with YERVOY or ipilimumab. We have reported on all the results of these slides earlier. What is new as of Q4? Last year is the 5-year overall survival in malignant melanoma, which is 50%. As of Q4 2020, the median overall survival has not been reached in this trial. If you move to the next slide, Slide 13. We have also the fourth Phase I trial at trial, that trial is in malignant melanoma, first-line patients. It's a trial where UV1 is combined with pembrolizumab, the PD-1 antibody. There are 2 cohorts in that trial. One cohort with a lower dose of GM-CSF, the adjuvant we use together with our vaccine, and 1 with a regular dose. The first cohort was included and patients were included first. And as of Q4 last year, we reported on 1-year landmark results from this trial. At one year, the 20 patients in the cohort 1 show an overall survival of 85% and median PFS was not reached. Results from the second cohort 1-year landmark results will be available next autumn. And also, we will follow the patients in both cohorts over the next years. If you go to the next slide. So then we move over to the TET-platform. As we have stated before, we have the TET-platform, which has been, until now, a preclinical platform where we combine the adjuvant and the peptides. The technology has been developed preclinically. And we have also announced that we will start a clinical trial early this year. On Slide 15, called the TENDU trial. The TENDU trial is a trial where this platform will be put into men for first time. It will be conducted in prostate cancer patients. It's a dose-finding trial with 9 to 12 patients. And it will start to include patients Q1 this year. I think that will end my presentation part, and I give the word now to Hans Eid.

[Hans Vassgård Eid, Chief Financial Officer]

Yes. Good morning. Then we move into the financial section, and we can move to Slide 17. If we start by looking at the full financial year 2020, as we expected, the negative cash flow from operations has increased significantly in this year. And that is due to the ramp-up of the R&D activities with the initiation of the Phase II trials. So following 2020, we had, by the end of the year, a cash position of NOK 441 million. If you look at the fourth quarter separately, the R&D costs are lower than we have previously guided, and that is due to some delays in the initial costs of some of these new clinical trials, where these costs are moving into future periods. Looking ahead on 2021, we expect a significant increase in R&D costs compared to 2020 and that is due to an increase in patient inclusion in the ongoing studies in INITIUM and NIPU trials and also the start-up of the new Phase II trials, the DOVACC and the FOCUS trials. And also on top of that, we have the start-up of the TENDU Phase I trial now in Q1 2021. Based on the current development plan and the current time lines, the existing funds are expected to take us through the readout of the primary endpoints in the Phase II trials in 2022 and 2023. If we move to Slide 18 and go a little bit more into the details of the financials. We can start to look at the full financial year 2020. The -- as you know, Ultimovacs has no revenues at this stage. So the development activities we have, they will lead to an operational loss and for 2020, this operational loss amounted to NOK 121 million. Comparing this to the previous year, 2019, the similar loss was NOK 61 million. And as we said, this is an expected increase due to the ramp-up of the development activities. If we look at the fourth quarter in isolation, the operating loss was NOK 25 million, which is at the same level as the fourth quarter of 2019. Again, some delays in some start-up costs of these last 2 Phase II trials. So that will move into next year. If we go more specifically to the main expense items, we can start with payroll expenses. And for Q4 in isolation, there is a certain increase due to 2 more full-time employees, somewhat higher share option costs related to the option program and some general increases in personnel expenses. Looking at the full year 2020 compared to 2019 there is a larger gap between those numbers, and we had given these explanations also in previously quarterly presentations. There are some -- a couple of elements influencing this. In -- for 2020, we have this severance pay liability of NOK 5 million related to the resignation of the former CEO. And for 2019, we have this reversal of a liability of NOK 10 million related to the former program of synthetic shares that was terminated when we did the IPO. So there are some technical reasons here why this gap is so big, this we have explained also previously. Then moving on to the main cost items, the R&D expenses and IPR expenses. Again, a significant increase in 2020 due to the start-up of the clinical trials. There are significant sort of start-up fees and start-up related costs. And these are the set up of sites or hospitals, the opening of these implies some additional cost in that phase and, of course, the start-up of the patient inclusion. Yes. Looking at Q4, again, in isolation, there is an actual decrease in R&D expenses. That is partly due to some large upfront expenses in 2019 related to the start-up of the INITIUM trial. But also related to the fact that some of the expected costs in this quarter are then moving into future periods, as we have described. When it comes to other operating expenses, there are insignificant changes from the previous year. Okay. We can then move on to the next slide, Slide 19. Took a quick look at the operational cash flow per quarter. Again, the picture is the same. We saw a significant increase in the operating cash flow in 2020 compared to 2019. That is as expected. And when we look ahead for -- again, on 2021, we do expect a significant increase in 2021 compared to 2020 again. Because we have the initiation of the 2 new Phase II trials, we have increased patient recruitment in the ongoing trials. And we also have the start-up of the TENDU trial now in Q1 this year and other R&D costs. So all in all, we should expect a further increase in negative operating cash flow. Yes. And the next slide, Slide 20, is more for information and reference purposes. So I'm not going to spend time on that in this meeting. So we can move on to Slide 21. And look at the news flow of Ultimovacs. The last quarter and the Q4 2020, we had significant news as Carlos and Jens have taken us through. We had the initiation of the DOVACC -- or the signing of the DOVACC trial and the FOCUS trial. And we also announced 5-year results from the malignant melanoma Phase I trial. If we look at the expected news flow for 2021, we will -- or we do expect the first patient in the TENDU trial to be treated in this quarter, the first quarter. Then when it comes to the 2 new Phase II trials, we expect the first patient in the DOVACC trial to be treated in the first half of this year and most likely in the second quarter of 2021.And moving on to the FOCUS trial. We expect the first trial to be dosed in that trial in Q2 or Q3 this year. In the fourth quarter of 2021, we then will have the readout of safety and efficacy in the ongoing Phase I trial in the U.S., the combination trial, UV1 and pembrolizumab, where we then will have the 2-year observation data for the first cohort and the 1-year observation data for the second cohort. And during the fourth quarter of this year, we will also have the interim readout from the TENDU trial on safety data and immune activation. In addition to this, we will continuously seek to have presentations and publications scientifically. And this will also possibly include some more detailed presentations of the data we presented on the ongoing Phase I trial, combination UV1/pembro in malignant melanoma at a scientific conference during the first half of 2021. Okay. So then we can move to the next slide, 22, and I will leave the word back to Carlos.

[Carlos de Sousa, Chief Executive Officer]

Thank you. Thank you, Jens. Thank you, Hans. So this ends the part in the presenting the Q4 results and move now to the theme that we selected for this quarter talking about intellectual property rights. So if we move to Slide 23. This is just so that people understand the timings linked to patent applications. So if you look there, and this applies, of course, to world biotechs and pharma. So if you look at the month 0 and you file an application, normally, it's going to take 18 months until there is an international publication, so the first time that the patent will become public. Then you need to spend a couple more months and then to file and prepare to then go around and file the patents in Europe, in U.S., China, Japan and basically on the national regional level. And then it's going to be depending, it may take 2 to 5 years, depending on the complexity of the patents, the discussion with examiners until you have the grants. So it's a very long process, but this is the same for everybody. We normally have sometimes a question, "Oh, why can't you tell us what the patents that you are filing?" And I will try to explain now. So here us, as a company, we have patents that are granted, where we have patents that are being under review and going through now the national regional process, and we have patents that we filed. And particularly also around the TET technology. So if we move to Slide #24, there is a very critical period of time that is until -- from submission, from application, until the international publication, where basically, it's very important there is no details out in the public being in interviews, in publications, in presentations in any way that can basically establish a disclosure of information that can impact the obtaining of this patent. So when we are very, very short in terms of words and say that we file patents, but we cannot really talk much about it is because we are in the silent period. So it's very important to understand that it's not because we don't -- we are not trying to be transparent, we are, as you know, as a company, we are very transparent. But we are in, for instance, at this moment, in the silent period for a series of patents that we applied for. So again, hopefully, that this is helpful in understanding, the reason why we cannot go into details, particularly during these first 18 months of the patent application process. So if we move to the next slide, Slide 25. And now I wanted to explain and clarify the different types of protections that we, as a biotech, and this applies to other biotechs and the pharma industry, in general, rely on. Of course, the first one are the patents. As you know, patents have a 20-year duration, and this applies to everybody, not just the biotech, but there is an additional period called the supplementary protection certificates that is 5 additional years. And then also, via the pediatric extension, we can get additional 0.5 year of patent extension. So this is the patent situation, and I'm now going through Europe and then I'll cover the U.S. So again, this is the same for everybody, and it's very important that you understand that it's not just the basic patent, there are extensions. Of course, as important in our industry are what we call the regulatory protections that grant market exclusivity. So the first one is that in Europe, we have an 8-year protection of all the data that was filed to support a marketing authorization when we applied for the new active substance like UV1. So this means that for periods after the application of 8 years, no one can have access to the data that we file. And then in addition, we have 2 more years of market exclusivity, where a potential generic competitor is not able to commercialize the generic substance. So we are talking in total here of a 10-year market exclusivity. And therefore, each additional indication, we have one additional year. So this is the market exclusivity and protection that is granted by the regulatory part of the filing, the data that is protected. Of course, there are other ways of gaining market exclusivity, for instance, one of the instruments is through orphan drug designation. So if we obtain orphan drug approval, and normally, this applies to -- it's not a product in general, it is a specific indication, then we, as a company, have an exclusivity in the market for the usage of the product in that indication for 10 years. And then if the product is being able to be used in pediatric then, and there is an investigation plan, paediatric investigation plan, then you can have additional 2 years. If we move to Slide 26, this is the situation in the U.S. is relatively similar, but are differences. It's, again, you have the 20-year normal period for patents, and you can get what is called, in this case, patent term extension after 5 years. There are other ways that this can be extended, but let's stay with the 5 years, so like in Europe. And again, you can get an additional 0.5 year of patent extension from the pediatric exclusivity. In our specific case, UV1 in the U.S. is a biological product. So this means that also has a specific regulatory pathway, but also a different type of protection. So again, we have a regulatory data protection that basically, for biologicals, give a 12-month market exclusivity, plus 0.5 year by the pediatric designation. Also, in the U.S., you have orphan drug market exclusivity is a little bit shorter than in Europe, but it's still 7-year market exclusivity for the commercialization of the product in that specific indication. So you see that the protection of the sales and the commercial rights is not just depending on the patent, it's also depending on -- and very strongly on regulatory data protection and other instruments in specific cases where a company can get orphan drug market exclusivity. So if we move to the next slide, Slide 27. This is just an example of the type of activities and data that you can patent and this is focusing Europe. So we can patent for new chemical entities, formulations, combinations, medical usage, different dosage regimens, if there is an ex vivo diagnostic methods, also the method of making and the process. So all these type of things, you can patent. And of course, different companies will have different goals at that and different ways of protecting it. For instance, in Europe, for the patent that we have in Europe for UV1, we have a mix of product claims that is the composition of matter, the basic patent, but also patents on the medical use of the claims like use in medicine and also be used in treatment of prophylaxis of cancer. So as you see, this is a very complex field that I'm trying here to simplify, but there are -- you can protect with patents different aspects of the compound or even the production of the compound. If we move to the next slide, Slide 28. Basically, we will do in Europe and the U.S. basically look in addition to the normal patent protection to these patent extensions. If we move to Slide #29, and here, as a company, we communicate the patents that are granted. As I mentioned, we have patents that are under review, patents that we have filed at different stages, some out of the silent period, other ones within the silent period. But here, just to say that although our basic patent expires and extended in 2031, then we have an additional 5-year supplementary protection certificate in Europe or the PTE in the U.S. that basically extends the patents to 2036, and this is just the patents. So to kind of summarize, if we move to the next slide, Slide 30, to try to make it clear what are the protections that we as a biotech have for our products so that, of course, the basic one is the patent protection, 20 years plus extensions both in Europe and the U.S., 5-year extensions, but then also very important, what we call then the market exclusivity or commercial exclusivity. This can be obtained by different ways. As in the U.S., for instance, where biological, we have a market exclusive at 12 years. This means this has different parts, for instance, means that the first 4 years, a company that wants to develop a biosimilar cannot have access to the data. So the data is protected. After that, although they may have access to the data, they cannot commercialize during -- within that period of 12 years. So very important protection because these are the years where the company is getting the revenues from sales. Again, as a company, we are going to look into that, then there is the orphan drug designation that, again, per specific indications, you then can get a market exclusivity for this specific indication in the U.S. for a period of 7 years, in Europe for a period of 10 years. Of course, outside of this, there is also other protections that are not by market exclusivity or patent protections but are depending on know-how. Of course, if you want to develop a product, if you want to commercialize a product, you have to manufacture. So you can have patents, but there is know-how in the production of these products, for instance, in case of UV1. And of course, as I said, we are not producing the tablets that is easy to manufacture. So there is know-how in the manufacturing process of UV1, and this is an additional protection because it means that someone will have to basically go through all the motions that we had and the time to develop a formulation of a product that then they can use in developing or commercializing. So it's just another layer of protection. So I hope that I tried to simplify what is a very complex field, but clarify that as a biotech, like all biotechs, we have different ways of protecting the commercialization of our products through patents and market exclusivity that can be granted by the fact that we have biological data protection in the U.S. or data protection, as I mentioned, in Europe, but also through market exclusivity in specific indications, if they are approved as an orphan drug. In addition, all the different know-how that exists in the companies that can also provide us additional protection. With this, I would like to move to the next slide. And again, so we are going to open now for QA. And please, if you already sent your questions, if not, it's still on time, and I will be joined by Hans and Jens and we will do our utmost to answer all your questions.

[Hans Vassgård Eid, Chief Financial Officer]

So the first question is related to patient recruitment, which is as follow. Could you add some more details around the rate of clinical trial recruitment and how you view the current pace and the need to accelerate this in order to keep to the anticipated readout time lines? Understandably, this is currently likely impacted by the pandemic, but do you see any recruitment headwind from competition from the many other checkpoint inhibitors that is recruiting?

[Carlos de Sousa, Chief Executive Officer]

I will start there in -- as I mentioned, every company. And in this case, every biotech in the world is facing the same challenges. And then, of course, the different companies try to address them. We are doing our utmost to minimize that impact. So we continue to recruit patients.Now again, the pace -- the pickup of recruitment, I think, as I mentioned, is going to be dependent on the lockdown situations, the rollout of the vaccines. We see a lot of interest in terms of recruitment and patients to be enrolled. So we don't see at the moment that there is a competition from the fact of the checkpoint inhibitors. I have to remind that in the INITIUM study, these patients are -- have to be treated with the combination of the ipilimumab and the nivolumab anyway. So we have just added to the treatment, so we are not competing with them. They are still going to be treated regardless of the study with ipi/nivo. So it's a benefit that we add UV1 to what this will be the standard of care and the treatment choice in these patients. We have the benefit, for instance, in the NIPU trial that Bristol-Myers Squibb provides us with ipilimumab and nivolumab so there's no competition, and the patients have free access to the compounds. So again, most of the challenges that we face are linked to the COVID-19 pandemic. We think we are doing a good job maneuvering these challenges. And we really cannot make projections or predictions, but we hope that as the vaccine rollout starts to improve that the situation was improved to society in general and, of course, to the hospitals, the way these patients are recruited.

[Hans Vassgård Eid, Chief Financial Officer]

Okay. Then we have a question on readout from the Phase II trials. It reads, "Will there be any interim analysis for overwhelming efficacy/futility of the 4 Phase II trials?"

[Carlos de Sousa, Chief Executive Officer]

Jens?

[Jens Egil Torbjørn Bjørheim, Chief Medical Officer]

Could you please repeat the last part of the question, Hans? It was little blurry.

[Hans Vassgård Eid, Chief Financial Officer]

Yes, will there be an interim analysis for overwhelming efficacy or futility of the 4 Phase II trials?

[Jens Egil Torbjørn Bjørheim, Chief Medical Officer]

So all the Phase II trials, they have a design so that there is no planned interim analysis. That is also very important when it comes to quality of the data. So interim analysis should be predefined statistically, and that will lead to increased number of patients if you want to go that direction. In the 4 Phase II trials from Ultimovacs where we are involved and there is no planned interim analysis. So the primary endpoint will be the first readout in all those trials.

[Hans Vassgård Eid, Chief Financial Officer]

Then we have 2 questions on the TET development, and they are quite similar, so I will read them both before you respond. The first one is, could you add some more details around the rate of clinical trial recruitment and how you view that? No, sorry, wrong question. I'll try again. Are you able to provide any further details on the TET program and what the next clinical study and/or indication might be? Assuming the TENDU trial reads out well, when do you expect to read out on the TENDU trial? That was one, and the other one -- in the Phase I prostate study on TENDU -- I'm sorry, if the Phase I prostate study on TENDU is successful, is your plan to continue with prostate in Phase II study or may another cancer type will be selected for Phase II?

[Carlos de Sousa, Chief Executive Officer]

Yes. I will start here. Regarding the TENDU study, this is a Phase I study. So we are going to have the full data in next year, but we -- because when the first patient is enrolled, we will have a press release where you get more details and -- but because there is patients are enrolled on the 3 plus 3 plus 3, so we will have -- be able to assess, for instance, the part that is interesting for us, one of them, that is the safety. So we expect by the end of the year to have some of the interim results on the safety. But the full results of that study will be during next year. At the moment, it is too early to be talking about what is the -- what are then the next steps for the TET-platform. I think we, as a company, we are very pleased to be able to initiate now a clinical study with the first product, but we need to continue to do some preclinical activities, manufacturing process activities, all this is happening. And as we continue that development and when more results, we'll be able to be more clear to the market in terms of what is going to be the strategy and the development program for TET. So sometime, we expect, next year.

[Hans Vassgård Eid, Chief Financial Officer]

Okay. Next question is also related to the TENDU trial and TET. It's most likely for Jens to respond to. In the TENDU safety study, a Boostrix vaccine will be given to participants prior to administration of the TENDU vaccine. Will that Boostrix vaccine be utilized in this manner in future studies as well?

[Jens Egil Torbjørn Bjørheim, Chief Medical Officer]

So for optimal effect from the TET-platform, you need to have antibodies against tetanus. We are all vaccinated in our childhood with that. So the booster vaccine prior to inclusion or prior to vaccination in the TET-platform is there to optimize the effect of the vaccine. We have not, in a way, done any analysis at this point to understand if the antibodies you have from your childhood is enough to booster the immune response from the vaccine. So until further notice, yes, there will be a booster vaccine prior to treatment with our TET-platform technology.

[Carlos de Sousa, Chief Executive Officer]

Yes. Just -- so if I can make an additional comment. So as Jens has mentioned several times, we want to make sure that we have the similar conditions when we run the trial. So it's important that all of these patients have the boost. Moving forward, as Jens mentioned, there will be a diversity of patients dosed that received the Tetanus boost. So we will look then and investigate the best way. But again, for this first trial, it was important that all the patients at the baseline, they're the same, the boost, so we can really assess the safety and the efficacy in terms of immune activation and -- in the TENDU study.

[Hans Vassgård Eid, Chief Financial Officer]

Okay. Then there is what seems to be the last question is related to IPR. Regarding intellectual rights, can you out-license single indications to multiple partners? Or will they want be out-licensed as a whole asset?

[Carlos de Sousa, Chief Executive Officer]

Thanks for this question because there is a -- normally, there's a lot of confusion about this topic. So let me start by saying different geographies, so in the U.S., you get a market authorization. And then basically, this means that the product is approved. And then the product will be used in different indications according to the data that you provide to the FDA to support the use of the product in those indications. In Europe, it is a centralized process. So it will be the same and again in other regions. So when you have a single market authorization, let's pick out the U.S. as an example, so it's easy to explain. So when -- there can only be one market authorization. This changed from the past year. So if there is only one market authorization, one company is the owner of that market authorization. So that means that all the sales for that product will go via that company. So as you can imagine, it makes it difficult or impossible to then split a license by indication because the sales will all go into the same company. So that is really not possible because it's very difficult to separate the usage of product in the market, the indication by indication. So again, when -- if a company gets the license to UV1 in the U.S, then is for all indications. So you can have a license that is -- covers the whole world as a territory for all indications, what you can do is that then have a separate license with a company in the U.S., with a company in Europe, with a different company in Japan, in China. So this is possible. But in these markets is for all indications. But as a value that we are going to capture the value of all indications because when you do a licensing deal, you capture not only -- not only the lead indication, but also what is going to be the milestones and the sales related to every indication that the product will be approved for. So the value is captured anyway. So trying to make it again directly, now it's -- you need to license the product for all indications, but you're still going to capture the value. But yes, it's possible to do what we call geographical licenses because then it applies to that specific geography.

[Hans Vassgård Eid, Chief Financial Officer]

Thanks, Carlos, and then there are no more questions.

[Carlos de Sousa, Chief Executive Officer]

Okay. So in that case, I want to thank the team that has been working -- the whole team at Ultimovacs that has been working very hard to deliver on all these milestones that we achieved last year. And of course, all our shareholders for their support and the Board. And again, for the ones that are participating in this call, thank you for your interest and for your questions, and we look forward to keep you updated in what we believe is going to be another important year for Ultimovacs. So we had a very successful 2021, but we also have a very busy -- a very successful 2020, but we are also going to have a very busy 2021, where as a company we'll put extra effort, of course, in handling the activities despite the COVID-19 pandemic and continue to deliver on the data and increase our visibility and presence to investors, potential partners and also to the scientific community. So I want to thank everybody, and looking forward for the next opportunity to communicate you -- with you and give you updates on what's happened within the company. Thank you, and have a great day.