Ultimovacs ASA

OSE:ULTI

Earnings Call Transcript

[Carlos de Sousa, executive]

Good afternoon, everybody, and welcome to the Fourth Quarter 2023 Results Presentation. My name is Carlos de Sousa and I'm the CEO of Ultimovacs. And as usual, I have with me Jens Bjorheim, our Chief Medical Officer; and Hans Vassgård Eid, our Chief Financial Officer. So we will go through the slides, the presentation, the results. And as usual, during the presentation, you have the opportunity to send us questions that we will try to address as many as possible after the presentation. So please do that.

So if we can move to the next slide, as usual, as a public listed company, I need to show this disclaimer. But let's move on to next slide and again, what is -- what was a very exciting, very successful fourth quarter 2023, but also the period right ahead of us as probably everybody knows at this moment, we are really approaching what we consider the key inflection point for UV1 and for Ultimovacs. And this is the near-term readout of the UV1 Phase II study, INITIUM in unresectable or metastatic malignant melanoma. We expect to read out basically around the corner next month in March 2024.

And let me -- Jens will go in a little bit more detail over the study. But as you know, INITIUM study is what we call a randomized controlled study that is best practice in the industry. So on one arm of the study, patients are treated what is considered today the gold standard in treating these type of patients, the combination of ipilimumab and nivolumab. And on the other arm, we add to the standard care, we add UV1. And the primary endpoint is what we call progression-free survival or PFS. This means that when we look at the data, we see how many patients didn't progress in the control arm, the ipi-nivo arm and in the experimental arm, the ipi-nivo plus the vaccine.

And if we meet this primary endpoint, if we show a difference over the ipi/nivo combination, this is what we call and consider a breakthrough of groundbreaking results. And why is that? Well, for a couple of reasons, that will be first for a cancer vaccine like UV1, is that we will be the first cancer vaccine that is off-the-shelf, showing a benefit in a randomized control study that we bring a benefit on top of ipi/nivo. And this benefit on top of ipi/nivo is something that the one has been shown in the specific set of patients. So we will be not only the first ones to show this benefit, but also the ones we're doing with off-the-shelf cancer vaccine. So this is really going to be major for cancer patients, of course, but also for UV1 and Ultimovacs.

And of course, we know already that there are a lot of eyes on Ultimovacs and expecting the results from the INITIUM study, because of these characteristics that if we have a positive study, this may open the gates to a lot of other vaccine -- cancer vaccine approaches that expect us to show that this concept of cancer vaccines work. Of course, to further increase that visibility because that is a very high ambition that we have is to make as many people in the world to know about this result and the success of UV1 if we show positive data.

The ambition is to present the data at a major cancer conference. For instance, the biggest one is ASCO in the U.S. Last year, 40,000 people participated -- attended that conference. Another alternative is ESMO that is the European correspondent cancer conference, 33,000 people participate in this conference. So as you can see, a big audience, that is even more important because who attends these conferences. Of course, all the doctors that work with cancer, nurses, patient advocacy groups, the regulatory authorities, all the big pharma companies operating and working in this field, specialized investors and also very importantly, to really spread the message globally, global media. Now we are talking about not only the trade media, but also the general media, for instance, like CNN. So it's very important that we have this opportunity in the lifetime of presenting data of the significance in such a big forum with an audience that, of course, if we do this, these are all experts that have the opportunity to review the data and consider its value to be presented.

But in addition to presenting the data at a medical conference, we also have the high ambition of publishing in the top-tier medical journal. This is also extremely important because this further enlarge the group specialists that will enter into contact with UV1 and the data and, of course, Ultimovacs. So we will be -- on positive data, we'll be looking at ways of really fulfilling this high ambition of presenting at a medical major conference and publishing it in top-tier journal. So very important because this, of course, as you can imagine, will bring a lot of value to the company, to our shareholders, will facilitate moving to the next phase of clinical trials because we have more positions that are comfortable with the data. The regulatory authorities will also be more familiar with the data. And of course, the big pharma that are the, as you know, the expected partners in a licensing deal and also attracting specialist investors. So extremely important, and we really keep this ambition, and we are working intensively to making sure that with positive data, we can reach these goals.

Some really, as I said, exciting and busy times ahead of us. But of course, as we can see in the next slide, we also had a very successful fourth quarter 2023. We -- the investigators presented at ESMO Conference in 2023, the results from the NIPU study in mesothelioma, that, as you know, is a terrible cancer type with very, very -- particularly in second line with very -- patients don't live for too long, unfortunately, and progress very fast. And we've shown some encouraging results there that Jens will cover.

We also announced that in our Phase I study in malignant melanoma, where we combine with pembrolizumab, we continue to see this plateau of survival, basically no deaths were reported between the 3-year follow-up and now the 4 year that we have last year. So this long-term survival that ultimately, the goal that we have in bringing this benefit for these patients. As you know, we also have a second technology, the technology where we had the first Phase I study, exploratory, where we met the primary endpoint for safety and also the secondary endpoint for immune activation.

We -- you know that we have 5 Phase II studies running, 3 of them are fully enrolled, the NIPU study already published the data, the INITIUM coming very soon. And the FOCUS study that we will have in the second half of this year. But we have these additional studies, DOVACC in ovarian cancer and LUNGVAC in lung cancer. These study started later. They had a slower start. But now we are very pleased to see that enrollment is picking up. And basically, we updated the guidance for expected results with the delay of just 6 months.

Also very important as we enter into the space, getting results and enter into discussions with potential licensing partners, it's also good that we were able to extend the runway to the end of 2024. So all these are very important achievements by the team. And -- but of course, we -- the next months are going to be extremely important for the future of the company.

If we move to the next slide, this is just to mention really, as you can see that as a small company, we have 26 colleagues in the company. We have a very ambitious and bit driven approach, have producing data across cancer, different multiple cancer indications in combination with different immunotherapies. As you see in the darker circles, these are the studies that are already enrolled and the 2 that are missing. And the part I just want to emphasize here is that really the interest we received from specialized oncology groups, but also from pharma because, as you know, we collaborate with Bristol-Myers Squibb in the NIPU study and with AstraZeneca in the ovarian DOVACC trial.

So with this, I will give the word to Jens, and I will come back to the end. So Jens, please go ahead.

[Jens Bjørheim, executive]

Thank you, Carlos. Good afternoon. So this part of the presentation is about the clinical trials. Just first on the first slide, if you go to that one. Just a small the presentation of the antigen, what we are vaccinating against as a reminder. So the UV1 peptide vaccine has one antigen target, and that is telomerase. So why is that? Then there's something called the hallmarks of cancer that are features that needs to be in place for normal cells to move into being a cancer cell or features that need to be in place to continue to be a cancer cell. To have a strategy for eternal cell division is something that is needed for a normal cell to translate into a cancer cell and in 85% to 90% of cancer, the enzyme called telomerase is turned down on setting the cells in a position for internal cell division. This is something that happens early on in the development of the tumor and continues throughout all stages of the tumor.

Also, this is something that is essential to keep there over time. So the tumor cannot mutate the telomerase to escape immune recognition. And also, this is a prerequisite for a tumor. So it needs to be in place prior to start of the development of the tumor for a normal cell to be actually able to do that. Also, it's expressed in all parts of the tumor, both in the primary tumor and in the metastases. So it's an antigen that is relevant in time and space, as to say, at all stages of the cancer and in all parts of the tumor and does not mutate over the course of time. So the immune responses we generate towards telomerase is that likely to be relevant over time and in all parts of the tumor.

So moving on to the clinical trials. And first, the result we presented last autumn from the UV1-103 trial. So this is a trial in malignant melanoma in patients with unresectable or metastatic melanoma that cannot be operated. We combined the vaccine UV1 with pembrolizumab and totally 30 patients were included in this trial. We did see a very good response among patients in this study. For example, 1/3 of the patients had a complete response. Nevertheless, the gold standard endpoint is overall survival, and we followed the patients for overall survival over the years, and we'll continue with that. At 3 years, we saw 69.5% of the patients still alive and there is no confirmed death between 3-year and 4-year follow-up as we reported this in quarter 4.

Moving on to the next slide. Here, we can see the Phase II program, we are either sponsoring or involved in. So totally 5 different indications. There is [ also ] different combination treatments. We always combined with checkpoint inhibitors, but in the different indications, different checkpoint inhibitors are approved as standard of care. The exemption from this is in the DOVACC trial where we combined with domvanalimab. There has been some clinical studies showing domvanalimab on top of olaparib and we want to see if -- the vaccine, UV1 will further increase the efficacy for these patients. Also among the 5 Phase II studies, and there are very different biologies we want to investigate the efficacy of the UV1 vaccine in different biologies. So for example, in the INITIUM trial, if you treat with ipi/nivo, you can expect a median overall survival up to 7 years. If you do checkpoint treatment in mesothelioma or, for example, head and neck cancer, the median overall survival is only a year.

So it's a big difference how good the CPIs are working in the different biologies. We want to understand how UV1, a vaccine that add extra T cells which we think are very relevant for the patients as they express telomerase and see how that leads to, hopefully, better efficacy for patients. Also this program is spread all over the world. The trials are recruiting patients in U.S., in Europe and in Australia. And as Carlos said, 3 of these trials are already fully recruited. We will wait for the last 2 to fully recruit. We announced NIPU trial at ESMO in October and now the INITIUM is up next month and the FOCUS trial second half of this year.

If we move on to the next slide, just to recap on the mesothelioma trial. So this is a randomized Phase II trial with unresectable or metastatic mesothelioma. Second-line patients, that means that the patients received chemotherapy as first-line and progressed on that and then they were included in this trial. Totally 118 patients were included from Scandinavia, Spain and Australia between June '20 and January '23. On the next slide, we can see the results from this trial. So the safety in the trial were very good. We saw a safety profile as expected for the ipi/nivo combination except for injection site reactions that we no occur when we vaccinate the patients and also something that is expected when you vaccinate in general. We did see an objective response rate, 31% versus 16% between the 2 groups and also a reduction in the risk of death by 27%.

Median overall survival 15.4 versus 11.1 months. The patients are continuously under monitoring by the investigators in this trial. They follow the patients, and they will update results over time. In parallel to the clinical results, there is also an extensive translational research being done around this trial. They collected both liquid and solid biopsies that hopefully will lead to better understanding of the mode of action of vaccines in this setting. Investigators will share updated information in a pre peer-reviewed setting, both as publications and presentations.

Moving on to the next slide. Also, as we informed after presentation of this data, we wanted to discuss the data with the authorities with the KOLs or external experts to understand the way forward within mesothelioma. We have received 2 designations from the FDA orphan drug designation in last year in October and now in February, fast-track designation for the vaccine in combination with ipi and nivo in mesothelioma. Moving on now to the next slide. with ipi/nivo and toxicity, I mentioned earlier in this presentation that we did see a safety profile very similar to the Ipi/nivo, expected profile, except for injection side effects events.

This is very important as ipi/nivo is a very toxic combination. It's very important that we don't add too much new safety on top of the existing safety profile. The main reason for that is that when you treat on top of the standard of care, it's very important that you don't interfere with the standard of care so that the patients need to stop that treatment. So adding new things on top of standard of care needs to be -- have a good safety profile, not to interfere with an established treatment of patients.

Moving on to the next slide. For mesothelioma, we are continuing to discuss the data with the key opinion leaders. We are following the market, the studies going on out there and also discuss with authorities, and we wait for updated data from the investigators to be presented when it's available. Next slide. So the next trial in line, it's the INITIUM trial. So the INITIUM trial is our sponsored trial, sponsored by Ultimovacs is in first-line advanced malignant melanoma or metastatic melanoma, patients that cannot go through surgery. This trial is also a randomized trial, where we add UV1 on top of Nivo and Ipi in a randomized fashion. The

trial is an endpoint-driven trial, and the primary endpoint is PFS. Inclusion started June '20 and ended in July '22, so 1.5 year back. Already last -- we had expected to have readout from this trial first half of 2023. At that point, 70 endpoints did had not occurred. And also, we have informed about this also at later presentations. Last autumn, it was decided to amend the protocol to also allow a readout of this trial after 18 months of follow-up of the last patient, which happened in January 2024. Therefore, it was a cutoff in January 2024, and we expect data in March this year. The top line results will therefore be presented within the next months.

Moving on to the next slide. Just to put this in context with the treatment landscape or advanced melanoma. So in patients that are not operable, they can be treated when you look at the CPIs along 3 different lines. If you don't tolerate the combination, the patient can be treated with monotherapy with PD-1, nivolumab or the pembrolizumab or with the combination of PD-1 and [indiscernible]. UV1-103 trial, which we presented overall survival data on is in the first line here, where you use PD-1. The INITIUM trial is in a different group of patients that cannot be operated those that tolerate PD-1, CTLA-4 or ipi/nivo. So the INITIUM trial and the UV1-103 trial are focusing on 2 different cohorts of patients.

Also, just for completeness and -- the drugs are approved for a given treatment of patients. That means that if the doctors think that they can remove the tumor, they will be operated and thereafter, treated with CPIs, it could be nivolumab or pembrolizumab for a period of time to reduce the risk of recurrence after the disease. Also, experimentally, as you can see above the large light green box, there are neo-adjuvant trials underway in this area. And it's also something that KOLs or external experts say it's a very interesting area for development of new drugs, the period before you do surgery on patients. So the neo-adjuvant setting is of high interest these days.

Moving on to the next slide. So this autumn second half of this year, we will also have a readout of another trial. That is the FOCUS trial in recurrent or metastatic head and neck cancer those that are PD-L1 positive. In this trial, patients are treated with pembrolizumab, which is the standard of care. And in the intervention arm, UV1 on top. Also here, the primary endpoint is PFS, but this time, not an endpoint-driven endpoint. It's the PFS rate at 6 months. The investigators in this trial, all from Germany, totally 10 sites have decided to have a readout of the data when all patients have been in the study for 12 months. Last patient were included in August 2023. So we expect top line results to be out in second half of 2024.

Moving on to the next slide, the last 2 trials in the Phase II program to the left, the DOVACC trial. This trial is conducted and sponsored by an NSCO, the Nordic Skin Cancer Organization, and they collaborate with AstraZeneca and ourself for drugs, et cetera. The trial is in women with a BRCA negative ovarian cancer is second line. This means that when patients have received the second line of chemotherapy. And if they respond to that, they can be included in this study. They will be randomized to 1 of 3 arms, Olaparib only, which is a PARP inhibitor. Olaparib in combination with durvalumab, which is [indiscernible] PD-L1 antibody or the triple combination. The statistics in this trial is between Olaparib and [indiscernible] combination. Recruitment was lower than expected in the beginning. Now it's really speeding up and more than 40% of patients have been included in this trial. We expect top line results first half of 2025.

The last trial is the LUNGVAC trial in first-line advanced der metastatic non-small cell lung cancer. Also more specifically patients that have a PD-L1 expression above 50% and none of these targetable mutations like BRAF, et cetera. Also a randomized trial. This is an endpoint-driven trial as well with PFS as endpoint. It's semiplemab in both arms, which is a PD-1 antibody. And in the intervention arm, UV1 on top. Totally 138 patients will be included in the study from 9 hospitals in Norway. At current recruitment is above 15%. And recruitment has been slower than expected by the investigators, and they are currently investigating how to move on with a higher inclusion rate. And when they have decided on what they will do, we will inform about this. Top line results are expected first half of '26 in this -- for this study.

Moving on to the next slide, the TET technology and the tender trial. So TET is a therapeutic vaccine concept for activating specific T cells that can target cancer cells. So we have had one clinical trial within this program. The TENDU trial. In that trial, we used prostate cancer-specific antigens not the telomerase neoantigens. And the study was conducted at Oslo University Hospital, totally 12 patients partly anticipated in the study. It was dose study with 3 different dose levels that were tested main endpoints was safety and also immune activation. And both of these endpoints were met in this trial. In parallel with the clinical trial, also, there has been advancement in the preclinical research, clinical development and manufacturing of the product. And this provides a valuable basis for potential expansion of the pipeline in Ultimovacs.

By this, I move over to Carlos for the remaining slides.

[Carlos de Sousa, executive]

Okay. So Hans, if you please go ahead with the financial part.

[Hans Eid, executive]

Thank you, Carlos. Thank you, Jens. We are now moving on to the financial update section. And moving on to the next slide. We -- by the end of the fourth quarter 2023, we have a cash position of NOK 267 million or roughly USD 25 million. And we are now expecting a financial runway through 2024 as Carlos also mentioned. This is a somewhat longer expected runway than we had guided previously. We have received a question today, if we have made any cost-cutting measures to change this guidance, that is not the case.

We have not specifically made any cost reduction. We generally have a very confident approach and culture in the company. And it's also the fact that Jens has just described that some of the clinical trials [indiscernible] are -- have been moving somewhat slower than anticipated in the first stages. So this is more reflecting the actual activity level, but we have not cut any key activities to reach this extension.

Looking at the EBIT or operating profit and profit before tax. For the fourth quarter of 2023, we had an operating profit of minus NOK 60 million and profit before tax of minus NOK 56 million. And for the full year 2023, we had an operating profit of NOK 260 million or minus NOK 260 million and profit before tax of minus NOK 189 million. If we look at the operating expenses comparing year-over-year, the negative operating profit for the full year of 2023, is roughly 20% higher than the previous year when we exclude the share option costs. And this is mainly driven by higher R&D costs. If we look at the R&D and IPR expenses, specifically, the Q4 2023 level is approximately the same as the average of the 3, 4 or 5 last quarters. Going forward, we expect the operating expense level to remain at this fair high level, and there will be quarterly variations. And this continued level will be driven by further progress in the Phase II trials, the CMC development and other R&D activities.

If you move to the next slide, we have the more detailed profit and loss breakdown. And starting with the payroll expenses, the total payroll expenses were lower in Q4 2023 compared to Q4 2022, but higher in the full year 2023 compared to the full year 2022. And if we look at the regular salary costs, these were higher in both the Q4 period compared to previous year and also the full year 2023 compared to the 2022 period. And this is primarily due to 2 more FTEs in 2023 and just regular annual salary adjustments. The share option costs fluctuates with the company's share price. So there is more variation to that cost component. Yes, the external R&D expenses -- the R&D costs were higher in the full year of 2023 compared to the full year 2022 where the main contributors to this increase were the INITIUM trial and manufacturing or CMC activities. For the quarter, specifically, we saw actually a decrease in Q4 '23 compared to the same period in 2022.

So if we move on to the next slide, we have an overview of the operating cash flow and the negative operating cash flow in was approximately minus NOK 47 million. And this compared to the operating profit of minus NOK 60 million, we see that the difference is due to changes in working capital and also that there are noncash elements related to the share option costs. On the next slide, we, as always, share a more detailed quarterly breakdown of the profit and loss statement, which may be helpful for analytical purposes. So I'm not going to spend more time on that now.

So with that, I give the word back to Carlos, who will take us through the last section.

[Carlos de Sousa, executive]

Thanks, Hans. So if we move to the next to slide. And regarding the news flow and milestone, again, we had a very successful second half of achieving all the goals that we had establish to ourselves. But of course, as I mentioned, everybody is waiting now for the results of INITIUM coming in March. But in addition to INITIUM, we will also continue to update on survival from the 103 study in combination with pembro. In the second half of 2024, we will have the top line results from the FOCUS study and then, of course, we'll continue with the other ones. So again, very busy, but very exciting times ahead can really totally change the company and the treatment of the cancer patient.

So if we move to the next slide, here I'm talking about the summary of the core and the time ahead. I think we are well prepared for the INITIUM readouts in next month in March. As discussed, meeting the primary end point will represent a major breakthrough as this will be an improvement over the gold standard of care. Our ambition there to -- on the back of positive results to present the state major medical conference and publishing top-tier journals will be very important to really drive value to the company and facilitate our activities moving forward. The NIPU data presented at ESMO conference last year by the investigator showed a clinical meaningful survival benefit without additional toxicity in a very difficult cancer to treat. We continue to -- based on the data, we are a data-driven company and very disciplined to continue sharing this data with, for instance, the regulatory authorities. So it's very rewarding to continue to receive, in this case, in mesothelioma, the orphan drug designation and fast track designation that will be beneficial for moving forward with the development. It's -- we are pleased to see that we continue to demonstrate the long-term survival in the 103 study. Then second technology, that technology continues to deliver. And of course, despite the challenge in the initiation part of the studies, DOVACC and LUNGVAC are moving and again, the updated guidance is just 6 months. And very important that the financial runway extended to the end to the rest of the year, so taking us across the data from INITIUM and from focus.

So with this, I want to thank everybody, and we can move now to the Q&A section.

[Hans Eid, executive]

Thank you, Carlos. We have received some questions, and we can start with the NIPU-related question to Jens. When can we expect updated survival data from NIPU?

[Jens Bjørheim, executive]

The data that was presented at ESMO in October were from August last year. So you would need some you will need more months to have any relevant differences to present I understand that there will be presentations of the data, both a presentation at a major conference and also further publications following the development of the study. We have not a concrete number, but I assume this will be presented in the autumn 2024, for example, at ESMO again.

[Hans Eid, executive]

Thank you, Jens. Then another question to you related to INITIUM or on melanoma. We look forward to the upcoming INITIUM readouts in malignant melanoma. If the data are positive, how might you determine which checkpoint inhibitor combination to assess in Phase III given that pembrolizumab and ipi-nivo are both being explored in Phases 1 and 2.

[Jens Bjørheim, executive]

Yes, that's an interesting question. So we have stated earlier that we believe that the vaccine as such is agnostic. So we could go with any of those drugs. We have developed now in Phase II with ipi/nivo and as we understand from the clinical experts out there and also when we look at the guidelines, et cetera, we understand that ipi-nivo will be around as a standard of care over the next period of time. So that is absolutely a very interesting way forward.

When it comes to other combination in melanoma and that is also interesting, maybe even more interesting than monotherapy in the advanced setting is earlier stages of cancer, like in the neo-adjuvant setting. Since our vaccine is off the shelf, it's ready to be used right away after diagnosis. And you have a window prior to operation that is planned. and that we could be part of a combination because it's already available for patients. And we are discussing this, of course, in parallel now how to move on into Phase III. We need to see the results from the ipi/nivo trial to decide fully on this and we'll be back with further information.

[Hans Eid, executive]

Thanks, Jens. Another question related to INITIUM. Has clinical practice changed since checkpoint 67 in evaluating patients probable toleration of CTLA-4. In other words, how are patients just judged to tolerate PD-1 versus the PD-1 plus CTLA-4.

[Jens Bjørheim, executive]

Well, so the combination with ipi-nivo is quite tough safety profile, but also it's the most effective combination of treatment. So those patients that have the right indication to get the combination. And if there is -- they are fit to get it, they will get the combination treatment as such. When it comes to experience around the combination, yes, so now the ipi/nivo combination has been around for some years, it might be so that doctors are -- and nurses are better at seeing safety earlier now than it was before and then make it easier to use this combination treatment in more patients. It has also been seen in different trials that if you get safety actions on this combination, it doesn't interfere with the efficacy of the combination even if you need to stop [indiscernible]. And one interesting study there is the CheckMate 511 study, where you have the ipi-nivo regular doses in one arm and the opposite or flipped doses in the other arm. So the exposure to the drugs are very different in the 2 arms. Still, you see the same efficacy in both arms, but very different safety. So yes.

[Hans Eid, executive]

Okay. Thanks, Jens. Another question to you related to GM-CSF. You are using GM-CSF adjuvant in combination with UV1. And GM-CSF is also investigated as a therapy in combination with checkpoint inhibitors. [indiscernible], it's UV1 and not GM-CSF that is contributing to positive effects from vaccination.

[Jens Bjørheim, executive]

Yes. First, just a comment on the clinical trials with GM-CSF in systemic therapeutic doses. So there is one study with ipilimumab plus minus GM-CSF on top with a higher systemic dose. And that this showed some months benefit in overall survival. Currently, there is another study running. It has been around for several years in the U.S. with ipi/nivo plus/minus GM-CSF in the therapeutic or systemic dose. They are waiting for overall survival in that trial. We use GM-CSF very differently. So we use it as an adjuvant. We use it intradermally, it's a local dose. It's a local administration that is meant to attract and activate logo antidepresenting cells or dendritic cells in the skin, and the dose is also at very low dose. We expect the GM-CSF to degrade before it has any systemic relevance.

[Hans Eid, executive]

Thank you, Jens. Then we also receive that question on IP for you, Carlos. Could you please elaborate on the new patent, what will it protect?

[Carlos de Sousa, executive]

Well, we continue to -- as a strategy of the company, of course, is a high value for biotech is really protect as much as possible through granted patents, the assets that we have. This is important for the commercial success. So these patterns are important in protecting the DV 1, particularly you're talking about combination with checkpoint inhibitors. And of course, for more details, you can find a lot more details in our quarterly report. But I think it's just a reflection of our strategy to file and be granted as many patients as patents as possible to extend the commercial value at UV1.

[Hans Eid, executive]

Thanks, Carlos. And then I think we have the last question for today, and this goes to you, Carlos. What do you expect the next 6 months to look like?

[Carlos de Sousa, executive]

Well, definitely very exciting and busy months. So of course, if Initium reads positive, this will trigger a series of activities. As mentioned, we will be discussing the results with the authorities, what is called the end of Phase II meetings and preparation for Phase III meetings. So a lot of the interaction with the regulatory authorities, both the FDA and the European authorities. A lot of work done by the medical team and the clinical operations team to really discuss with key opinion leaders and experts in the area. What will be the natural next to phase the development has design in melanoma. We will also accelerate the discussions with potential partners and they are all also waiting for the data to potentially accelerate that. And of course, we'll continue to introduce the company to the bigger community, medical community in these medical conferences, not only the big ones but also smaller ones, present more data, more publications, introducing the company also to specialist investors as we move forward.

So all these activities are running in parallel. Another activity that we expect to conclude the series is to make sure that we are already producing UV1 under a commercial process, and we are now through the production, what is called the validation batches. So all these things are running and will be a very great value for the company and, of course, for our shareholders. And ultimately, our goal is to make an impact on cancer patients' lives by extending the survival. And hopefully, in some of them to cancer the -- to cure the cancer. So this is what is all expected in the next months ahead.

[Hans Eid, executive]

Thank you, Carlos. I think we stop there. There are a few other questions that have already been addressed during the main part of the presentation. So that was the last question for today.

[Carlos de Sousa, executive]

Okay. Then I want to thank Hans and Jens for the excellent support as usual. But of course, I want to thank all the listeners for their support. It's important that we continue to get support from our shareholders. as we are embarking in this mission to make an impact on cancer patients' lives. So thank you again all for your support, and we will keep you updated as we continue to get news. Thank you.