Good day, and thank you for standing by. Welcome to the Evaxion Biotech Business Update Full Year 2024 Conference Call and Webcast. At this time, all participants will be in listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please note that today's conference is being recorded. I would now like to hand the conference over to your speaker, Christian Kanstrup, CEO. Please go ahead.

Thank you so much, and good morning and good afternoon to all of you, and a very warm welcome to this Evaxion full year 2024 business update call. I'm Christian Kanstrup, CEO of Evaxion. With me today, I have Birgitte Rønø, our Chief Science Officer; Thomas Schmidt, our Chief Financial Officer; and Mads Kronborg, our VP of Investor Relations and Communications. I think it's fair to say that 2024 was a super exciting year for Evaxion with lots of achievements throughout the year, and we are looking very much forward to be giving you an update on the year. And the agenda and what we intend to cover. First of all, I will start out recapping on 2024, looking ahead into 2025 and some of the significant milestones that we see in front of us. Birgitte will be taking us through the R&D update. Thomas will cover the 2024 financial results. And I will be having a few conclusive remarks before we, as usual, jump into the Q&A. And another thing that is as usual is the forward-looking statements. We will be talking about the future. And of course, talking about the future entails uncertainties. Hence, I direct your attention to the forward-looking statements slide on Slide #3. And with that, let's get into the agenda and start out with recapping on '24 and looking ahead. First of all, as I already said, I think it's fair to say 2024 was a year of substantial progress across Evaxion. That goes for all parts of the business; if we look at business development, if we look at R&D, if we look at our platform and also when we look at financing. I'm truly proud of what the team and the whole organization has achieved throughout the year. I think it's also…

Thank you, Birgitte. I think we can only all agree that it has been a truly exciting year across both cancer and infectious diseases and that surely makes for an exciting 2025 as well. But let's look a little bit more at the past year and zoom in on the numbers. So, Thomas, will you take us through the financials, please?

Yes. Thank you, Christian and Birgitte. If we move to the financials and the financial highlights to start with, for 2024, we have recorded revenue of US$3.3 million, coming from the actions -- option and license agreement with MSD, which Christian mentioned earlier. This certainly also may generate income for the future. As Birgitte also says, we are on track to the next -- towards the next milestone payment in the second half of this year, plus, of course, then hopefully, in the years beyond. In 2024, we've also seen lower spend compared to the previous year. And this has very much been driven by the full year impact from the changes that we made back in 2023 and certainly also ongoing cost optimization and further initiatives in order to manage our cost and cash burn. We are certainly trying to make the best use of the cash that we have at hand. And end of December 2024, cash and cash equivalents were at $6 million, which is slightly up from $5.6 million end of 2023. But of course, then also having made the effort of investing into our pipeline and platform. We've seen significant improvements in our equity and the financial position through the -- also the recent capital market activities. And with now our existing cash position, we estimate that we have sufficient funds to fund our operating and capital expenditure requirements into mid-2026. And important to note is that, that takes us beyond the point of a potential option exercised by MSD and also beyond our two-year clinical data readout on EVX-01. If we look at the profit and loss statement of 2024, we have had a net loss for the year of US$10.6 million. That's corresponding to US$0.20 per basic and diluted share, which is also…

Excellent. Thank you so much, Thomas. And also, thanks again to you, Birgitte. Let me just provide a few conclusive remarks. If we look at the overall picture, I would say, Evaxion has never been in a stronger position fundamentally. We have been delivering strongly on our pipeline, both from a cancer and infectious disease point of view. We are in the fortunate situation that the EVX-01 continues to deliver very strong clinical data. And we have a lot of activities within the infectious disease area where there are significant unmet needs, given many of the indications that we are targeting don't have any approved vaccines today. So, combining that with a transformative agreement with MSD, MSD as a significant shareholder, and a solid cash position, we are in a very strong position fundamentally which provides a solid basis for 2025. And I would say here that we are well positioned for strong '25 execution. We have our milestones, our value triggers and our priorities locked-in. And the full organization is around that. And we are well on our way towards executing upon our 2025 priorities. This all comes from having a clear strategy with a strong focus on monetizing value through business development via both the platform and the pipeline. And that, of course, also leads to several key value catalysts coming up in 2025. We are talking about the potential option exercise from MSD, EVX-01 Phase 2 data, and, of course, a number of other important milestones coming up throughout the year. So, I think, I speak on behalf of the whole management team and the whole organization, but I can say that we are very pleased with where we are and definitely looking very much forward to 2025. And with that, we will open for Q&A and take any questions you might have.

Thank you, sir. [Operator Instructions] We are now going to proceed with our first question. And the questions come from the line of Thomas Flaten from Lake Street Capital Markets. please ask your question.

Thank you. Good morning and good afternoon. Christian, I was just wondering, as you select new pipeline candidates, you've got two infectious disease and an ERV candidate that you're going to select this year, how are you certain that those will be partnerable assets? Are these being done with input from potential partners? Is it based on literature? I'm just curious if you can take us through that decision-making process a little bit.

Yeah, no, thanks, Thomas. I think that's a super relevant question, of course, because it is about creating partnerable assets, especially when you have a multi-partner approach, then you need to make sure that what you're developing is also what people want. Of course, it all starts with, you can say, the unmet medical need and the commercial potential. That's kind of like the first gate that you can, of course, find many areas where there's either not a whole lot of unmet need or the commercial potential is not sufficient. So that's the number one priority. And then, we do actually -- and that's what we are planning for both, say, the ERV-based concept, but also some of the infectious disease candidates we are working on. We're aiming at taking early dialogues with potential partners saying, "This is what we intend to do from a preclinical package point of view. Are there any other things you would see?" Not because we want to engage necessarily in partnering discussions now, but solicit the input from future potential partners. And I do believe that it's very important that we get this input early. So, the preclinical program can be shaped in the right way. Of course, we have a lot of things we would like to do, but we also need to make sure that we have the package that potential partners are asking for. And Birgitte, I don't know if you want to say a few more words on this, but this early consultation is definitely something that we have -- will have focus on for, you can say, the ERV program for some of our infectious disease programs, especially when you are in areas where -- which are novel and you're breaking new ground, then it's critical to understand what would a potential buyer want to see as early as possible. Birgitte Rønø: Yeah. Especially for the two new infectious disease vaccine candidates that we will nominate this year, I mean, there's, of course, the option, as you also allude to, Thomas, that it could be coming from partner discussions, but we also have done a lot of work on looking into different options. We have a long list of potential diseases to target, and we've done as you call it, literature analysis, trial analysis looking into the medical need, the commercial potential and feasibility. And we are definitely ready to launch a new program in this first half of [2023] (ph).

Excellent. That's super helpful. And with respect to ExpreS2ion Biotech handing the rights back to the CMV vaccine, can you give us some color behind that? Was the decision on their end? Was it a joint decision? Is there any capability that you're losing in the development program with them no longer being a partner?

Let me first answer the overall. I mean, the decision was at their end. The way the program is structured is that either party could terminate, then the rights would go fully back to the other parties. So, you can say we have not had the cash up or anything, but have, as per contract acquired the full rights, which we are very pleased with. And then, to the capabilities, if Birgitte, you can speak to that, but I think we have definitely a good plan in place and looking forward to drive this forward on our own. Birgitte Rønø: Yeah. So, ExpreS2ion Biotechnologies, they were doing some of the production part of the antigen. And of course, we're looking into other solutions for getting the antigens into our lab and to test them and we have also experienced that when we have partner dialogues, it's not always the right approach to come with a very defined modality. Partners often tend to have their own preferences, and therefore, we would also need to test our AI-Immunology identified targets on a few different vaccine modalities. So that's the ongoing work currently. And then, we are, of course, preparing for the selection of the vaccine antigens in the second half of 2025.

So, you can say we, of course, have truly enjoyed the collaboration with ExpreS2ion Biotech over the past couple of years and have been very pleased with that. Then, I think this also gives us quite a unique opportunity for deploying some of the learnings that we have had over the past couple of years in many of the partnering discussions that we have had as to having some degree of flexibility in how you pack or wrap the final vaccine candidate. So, we have -- as I said, we have a good plan in place and are looking forward to selecting lead antigens in the second half of the year.

Great. Thank you for taking my questions. I appreciate it.

Thank you. [Operator Instructions] We are now going to proceed with our next question. And the questions come from the line of Swayampakula Ramakanth from HCW. Please ask your question.

Thank you. Good afternoon, Christian and Birgitte. A couple of...

Hey, RK.

Hi. A couple of quick questions. The first one being on EVX-01. So, in terms of the data coming out at AACR, what sort of data should we be expecting? And then, more importantly, as we wait for this two-year data point coming up later in the year, based on your conversations with potential collaborators to date, what amount of data do you think eventually is sufficient for a transaction? Because this is a program that's been -- that I think has produced a pretty good set of data. So, what else are people really looking for? Birgitte Rønø: I can start. So, for the presentation at AACR, we will be presenting biomarker data and also additional T cell data from the patient. And we have already shared some of these earlier data, and we have now collected more samples and analyzed more samples from the patients. So, it will be a more in-depth biomarker presentation at AACR.

And then, for the, you say, data, what's needed, I do think that the data that we are currently generating and also we'll be generating over the remainder of the trial, that is the data that we need. What is also then important for, you can say, an eventual transaction, that's definitely also there's a lot of people waiting to see what are the data Merck and Moderna is going to generate going to look like. And of course, here, we were pretty encouraged seeing that Moderna was out of the TD Cowen conference earlier this year saying that they are anticipating approval in 2027. Hence, continued good progress with their personalized cancer vaccine. And I would not expect that one would need to wait until approval, but it will be interesting to see some of the early Phase 3 data from that trial. That's clear that people are also awaiting that. So, I would say, we have what I feel is needed from an EVX-01 point of view. And then, there's some level of confirmation that those data would also hold up in a larger-scale later-stage Phase 3 trial, which we hopefully will see later on this year.

Perfect. And then, regarding the ERV vaccines that you plan to work on, what types of cancers could potentially be the indications that we could use this vaccine to evaluate? Birgitte Rønø: Yeah, really good question, RK. So, we have worked with ERV concept for quite some time now. We have looked into a lot of data from different cancer indications and have mapped out the indications where there is a high burden as we called it and that has led to the development of this precision group vaccine concept, where we can see that in specific indications that these sequences are shared across the patients. And we have a list of these cancer indications that we would like to work more on, and we will most likely also share some more information by the end of this year on possible indications to move forward with.

Okay. And then, the last question from me. Regarding EVX-B2 and B3, would you be releasing any data ahead of submitting to MSD or as you're submitting to MSD for their decision on exercising the option?

No. You could say for B2, MSD is doing some confirmatory work on the data that we have generated. Hence, we will not be releasing more data there. B3, that's the finalization of the current -- of the work plan that we agreed in 2023. That's being completed. And the major part of work there is with MSD as well.

Okay. Perfect. Thank you, both. Thanks for taking all my questions.

You're welcome. Good talking to you.

[Operator Instructions] We have no further questions at the moment registered. So, I will now hand back to Christian Kanstrup for closing remarks.

Thank you so much. And I just want to wrap up by saying thank you to all of you for listening in, and thank you for the questions as well. As already said, 2024 was a very exciting year, creating a strong foundation for 2025. We are now in execution mode and we'll be focusing on delivering on our key milestones for the year. So, we are definitely looking very much forward to 2025. And we'll, of course, make sure to keep you all up to date on all recent events with Evaxion. So, once again, thank you so much for taking the time for listening in, and we will stay in touch.

This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a good day.