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 speaker's presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. 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 giving you an update on the year. 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. 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 statement slide on slide number three. With that, let's get into the agenda and start out with recapping on 2024 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 fair to say that it has provided us with a very strong foundation going into 2025. If we start out looking at business development here, of course, we entered into the transformational partnership with MSD in September 2024, a very important achievement for the year. I'm also happy to say that we are tracking well towards potential option exercise in the second half of 2025. Birgitte will also be getting back to this. Also, I'm pleased to say that our current business development pipeline supports our ambition of at least two new agreements. Just to recap, we have a very strong focus on partnering as a way of realizing the value of both our platform and pipeline, and of course, maintaining a business development pipeline, which can generate future partnerships, is important to us. From an R&D point of view, we have continued the successful execution of the ongoing EVX-01 Phase 2 trial. We presented convincing one-year data in the fall of last year, 69% overall response rate at the one-year readout of the ongoing Phase 2 trial, and 15 out of 16 patients showing a reduction in tumor target lesions. Truly exciting data, which makes us look very much forward to the two-year readout that we will be having in the second half of the year. What we have also done is established a completely new precision cancer vaccine concept, deploying our AI Immunology Platform, targeting non-conventional endogenous retroviruses, tumor antigens, which are shared across patients. This is exciting because it broadens the potential of cancer vaccines, and a precision-based approach is a very nice complement to our personalized cancer vaccine, EVX-01, which is complemented nicely. Looking at the platform, AI Immunology, it's the core of our business. Of course, ensuring an ongoing development and performance improvement of the platform is critical for staying at the forefront of AI-derived development of novel medicines. Here, I'm very pleased that we last year launched a novel Toxin Antigen Predictor, which allows us for developing even better bacterial vaccines. This continuous improvement of both capabilities and the performance of AI Immunology remains a priority to us. Last but not least, financing is, of course, an important factor in our business. Here, I'm pleased to say that we via public offering and other capital market activities have extended our cash at hand to meet 2026. In addition to that, Merck Global Health Innovation Fund or MSD Global Health Innovation Fund have invested in us for the third time, now holding a close to 20% equity stake. We are very pleased about the strong relationship we have with the Merck Global Health Innovation Fund or MSD Global Health Innovation Fund and are pleased to see the continued and ongoing support and, of course, welcome them as a significant shareholder in Evaxion. If we then turn to the next slide and look ahead, we have quite significant value triggers coming up throughout the year. I'm also pleased to say that we already delivered on our first milestone for the year, which is the all patients completing dosing in the EVX-01 trial. What we also will be presenting later on this month, actually, at the AACR meeting, is additional EVX-01 data. Looking into the second half, a number of significant milestones here. The MSD Vaccine collaboration and the decision on option exercise is expected in the second half could generate up to $10 million in income to Evaxion if MSD exercises the options to both. Needless to say, a very important milestone for us. As I already mentioned, pleased to see that the collaboration is on track. We will have the two-year readout on EVX-01 in the second half of the year as well. With a strong one-year readout, we are very much looking forward to that. We will be selecting lead antigens for our CMV vaccine candidate, which now is a fully owned candidate, which we also are looking forward to. Building on the precision vaccine concept discussion or comments I had just before, we will be selecting lead vaccine candidate in the second half as well. Throughout the year, two other significant milestones: business development. We have the ambition of generating at least two new agreements in 2025 and are working hard towards that. Continuing building our pipeline is also a priority with a multi-partner approach, partnering around existing pipeline candidates, just as we included the EVX-B2 in the collaboration with MSD. We need to continue to build the pipeline with novel candidates in order to ensure that we have an attractive and broad pipeline of novel vaccine candidates, which we can partner via our multi-partner approach. Here, we have the target of two new pipeline candidates within infectious diseases, one in the first half and one in the second half. Also here, pleased to say that we are well on track towards meeting that. Just a very quick recap on our focus. Our focus is on deriving value from both our platform and our pipeline. The unique nature here is the complementarity of having a dual focus on platform and pipeline, which is driven by the unique capabilities and properties of AI Immunology and the multidisciplinary capability set we have built around our AI Immunology Platform. Focus of the platform is to enter into high-value, low-risk partnerships around target discovery, design, and development of novel vaccine candidates. The MSD collaboration around EVX-B3 is a good example of that. It is, of course, also deploying the platform to expand and build our own pipeline, just as we have the target of these two new infectious disease candidates for the year. Pipeline that is around advancing select high-value programs into preclinical and early clinical development, leveraging our multidisciplinary capability base, and then pursue partnering at the right point in time. The partnering with MSD around EVX-B2 is a good example of what we want to do here. We have EVX-01 in Phase 2 development and very much looking forward to the clinical data readout later on this year. Focusing on both platform and pipeline, but being able to do so in a cost-effective way via the unique features of the AI Immunology Platform and the multidisciplinary capabilities we have around that. We are confident that this strategy will generate significant opportunities going forward and are executing in full focus on that. Before handing over to Birgitte, I would just touch a little bit on a few recent events. In January, we completed a public offering, and together with other capital market activities, we have raised $17 million this year, extending our cash runway to mid-2026. As already mentioned, MSD Global Health Innovation Fund participated in the offering, but what I am also very pleased around is to see other healthcare-focused investors in the public offering. With that offering, we have had a very nice expansion of our investor base and looking forward to continuing the collaboration with those investors we got in that round. We have also communicated that we are in agreement and discussions with the European Investment Bank around conversion of EUR 3.5 million out of the EUR 7 million loan we have with EIB into an equity-type instrument. Originally, we had communicated we expected that completed in the first quarter. We can see that some of the legal documentation takes longer to complete than anticipated, but now we are expecting to complete this in the second quarter. This will enable a significant simplification of our balance sheet and also save costs in terms of interest payments going forward. We are looking forward to having that loan conversion converted into equity. We in 2024 got a delisting determination from Nasdaq. We are very pleased to say that has been withdrawn here in the first quarter. We are now in full compliance with all Nasdaq listing requirements. Another thing that makes me proud and happy is the ongoing efforts in the whole organization in terms of optimizing our spend. That has enabled us to have a 2025 operational cash burn at $14 million, which is the same level as 2024, despite an increased activity level. This ongoing spend optimization is, of course, important because it allows us to do more while still being very cautious in how we spend our cash. Finally, also for the first quarter, EVX-01 completed dosing. I already mentioned that. What we also have announced is that we have extended the EVX-01 trial from two to three years. Important, this is not because we have not seen good data or the data we expected. On the contrary, it is because we have seen very good data. We had the opportunity of, in a very cost-effective way, given patients are in the trial, given we had EVX-01 already produced, to extend the trial with one year at minimal cost. This allows us to generate three-year data on this truly novel personalized cancer vaccine, which will create for a very strong data package. I am excited about that opportunity of expanding the trial, and Birgitte will also be getting back to that. Birgitte, I will hand over to you to give an update from an R&D point of view. Thank you, Christian. We have a broad R&D pipeline of AI Immunology designed cancer vaccine candidates spanning two major disease areas, cancer and infectious diseases. Today, I'll walk you through some of our most important programs where we've made significant recent progress. I will begin with our lead asset, EVX-01. This is our personalized peptide-based cancer vaccine currently in phase two clinical development, as Christian just mentioned. I will touch on the advancement in our precision cancer vaccine program, targeting this novel class of tumor antigens that we have seen are shared across patients. I will give an update on our two bacterial vaccine programs, EVX-B2 and B3, which are part of the licensing and option agreements that we have with MSD, as Christian mentioned earlier. I will give a brief update on our cytomegalovirus or CMV vaccine program. EVX-01, as mentioned, is currently in phase two and is being developed as a first-line treatment for advanced melanoma. EVX-01 includes multiple patient-specific new antigens that we have identified with our AI Immunology Platform based on the patient's unique tumor mutational profile. We administered EVX-01 in combination with the checkpoint inhibitor anti-PD-1 from MSD with the goal of enhancing clinical efficacy. As Christian mentioned, we shared one-year interim data at the ESMO Congress in September last year, and we reported an overall response rate of 69%, comparing favorably to historical pembrolizumab monotherapy data. Further, we showed that 79% of the EVX-01 vaccine new antigens induced a specific immune response in the patients, confirming the precision and predictive power of our AI Immunology Platform. Building on this positive data and to further explore the ability of the immune response and also the clinical response, we have, as Christian mentioned, extended the phase two trials one additional year to allow us to collect three-year outcome data. Notably, during this extension phase, EVX-01 will be administered as a monotherapy, allowing us to better understand the vaccine's standalone effect. As Christian also mentioned, this extension involves minimal additional costs as the clinical trials are already up and running and the vaccines are actually ready to be used. We are looking forward to sharing further updates on this program first at the upcoming AACR Annual Meeting later this month, and to present two-year efficacy data in the second half of 2025. Let's turn our focus to our promising precision cancer vaccine concept. In this program, we're using AI Immunology to design a precision vaccine targeting these non-conventional antigens, so-called ERV tumor antigens, that are shared across patients. At the ESMO Immuno-Oncology Congress in December, we presented preclinical proof of concept data demonstrating that our vaccine concept induced a strong antigen-specific T-cell responses in those immunized mice and in human immune cells, and further that we could inhibit the tumor growth in preclinical models. As Christian also alluded to, we believe that this precision approach could allow for a broader applicability of these cancer vaccines, also for patients that are less likely to respond to conventional cancer immunotherapies. With these very promising data in hand, we are on track for selecting the lead candidate in the second half of 2025. Our collaboration with MSD continues to progress as planned. In 2023, we entered into a target discovery collaboration focusing on a bacterial pathogen causing severe medical issues and where there are no existing vaccines approved. In 2024, this collaboration was significantly expanded to include an option and license agreement for our proprietary EVX-B2 gonorrhea vaccine candidate. We received an upfront payment of $3.2 million with a potential $10 million upon option exercise and further up to $592 million per product in milestone payments. Both EVX-B2 and EVX-C3 are advancing steadily, and we remain on track for a potential option exercise in the second half of 2025. We also make strong progress in our cytomegalovirus vaccine program. CMV is a widespread viral pathogen with high global seroprevalence. It causes severe complications, especially in immunocompromised patients, and also congenital infections can lead to severe birth defects. Yet no approved vaccines currently exist. With AI Immunology, we have identified novel B-cell and T-cel l targets, which can complement known antigens such as glycoprotein B. This program was initially launched in partnership with ExpreS2ion Biotechnologies, as Christian mentioned, and we now have acquired full rights positioning us to drive the program forward independently. With these very positive data, we are on track for vaccine antigen selection in the second half of 2025. Just to wrap up, we've seen significant progress across our pipeline in both oncology and infectious diseases, and we are extremely excited about what lies ahead and are looking forward to updating you on our programs as they continue to advance. 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. Let's look a little bit more at the past year and zoom in on the numbers. Thank you, Christian and Birgitte. If we move to the financial and the financial highlights to start with, for 2024, we have recorded revenue of $3.3 million coming from the 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 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. At end of December 2024, cash and cash equivalents were at $6 million, which is slightly up from $5.6 million at end of 2023. Of course, we have also made the effort of investing into our pipeline and platform. We have seen significant improvements in our equity and the financial position through also the recent capital market activities. With now our existing cash position, we estimate that we have sufficient funds to fund our operating and capital expenditure requirements into mid-2026. Important to note is that that takes us beyond the point of a potential option exercise 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 $10.6 million. That's corresponding to $0.20 per basic and diluted share, which is also a slight or improvement, so to speak. Still a loss, of course, but versus 2023, where we had a loss of $22 million. Again, the loss was really driven by improvement in our recognized revenue, but certainly also, as mentioned, the reduction in our R&D and G&A expenses. Most of that came certainly from a reduced headcount, but we've also made changes throughout the entire organization, including management and the full year impact of that. Plus, as mentioned, the general cost optimization is ongoing and has really played through throughout the entire 2024. Looking a little bit ahead for 2025, Christian also mentioned that we expect that our operational cash burn is on par with 2024, meaning again also around $14 million for the year. That is despite that we will increase our activity level throughout the pipeline and platform element. Balance sheet, we have certainly improved the equity throughout 2024, as mentioned, and continuing to invest in our pipeline and platform. Also in the beginning of this year, we have further had successful equity improvement. Cash and cash equivalent as of 27th of January were $11.9 million. Our public offering, which closed on 31st of January, we could add a gross proceeds of $10.8 million towards our cash and cash position. With that also, we are well above the Nasdaq minimum requirement on equity and shareholders' equity, which also, again, as Christian mentioned before, also we managed therefore really to be back in full compliance with the Nasdaq requirement, not only now in Q1, but expect to be that also for the remaining part of 2025. Cash runway will take us to mid-2026, as already stated. Again, just to do that once again, that will further extend with a potential MSD option exercise. Should that happen, and assuming that exercise will happen in the second half of 2025, we will have a cash position well into 2027. With that update on the financials, I hand it over to you, Christian. Excellent. Thank you so much, Thomas. 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 do not have any approved vaccines today. 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. I would say here that we are well positioned for strong 2025 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. 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 two data, and, of course, a number of other important milestones coming up throughout the year. I think I speak on behalf of the whole management team and the whole organization when I say that we are very pleased with where we are and definitely looking very much forward to 2025. With that, we will open for Q&A and take any questions you might have. Thank you, sir. As a reminder to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Once again, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Thank you. We are now going to proceed with our first question. The questions come from the line of Thomas Flaten from Lake Street Capital Markets. Please ask your question. Thank you. Good morning. 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. That's the number one priority. We do actually, and that is what we are planning for both, you can say, the ERV-based concept, but also some of the infectious disease candidates we are working on, 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. I do believe that it is very important that we get these 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. Birgitte, I do not know if you want to say a few more words on this, but this early consultation is definitely something that we will have focus on for, you can say, the ERV program, for some of our infectious disease programs, especially when you are in areas which are novel and you are breaking new ground. It is critical to understand what would a potential buyer want to see as early as possible. Yeah, especially for the two new infectious disease vaccine candidates that we will nominate this year. I mean, there is of course the option, as you also alluded 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, dry analysis, looking into the medical need, the commercial potential, and feasibility. We are definitely ready to launch a new program in this first half of 2023. Excellent. That's super helpful. With respect to ExpreS2ion Biotechnologies handing the rights back to the CMV vaccine, can you give us some color behind that? Was it a decision on their end? Was it a joint decision? Is there any capability that you're losing in the development of the 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 party. 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. To the capabilities, Birgitte, you can speak to that, but I think we have definitely a good plan in place, and I am looking forward to drive this forward on our own. ExpreS2ion Biotechnologies, they were doing some of the production part of the antigens. Of course, we are looking into other solutions for getting the antigens into our lab and to test them. We have also experienced that when we have partner dialogues, it is 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 Platform-identified targets on a few different vaccine modalities. That is the ongoing work currently. We are, of course, preparing for the selection of the vaccine antigens in the second half of 2025. You can say we, of course, have truly enjoyed the collaboration with ExpreS2ion Biotechnologies over the past couple of years and have been very pleased with that. 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. I think we have, as I said, 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. As a reminder to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We are now going to proceed with our next question. The questions come from the line of Swayampakula Ramakanth from H.C. Wainwright. Please ask a question. Thank you. Good afternoon, Christian and Birgitte. Hey, okay. A couple of hi. A couple of quick questions. The first one being on EVX-01. In terms of the data coming out at AACR, what sort of data should we be expecting? 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 I think has produced pretty good set of data. What else are people really looking for? I can start. For the presentation at AACR, we will be presenting biomarker data and also additional T-cell data from the patient. We have already shared some of these earlier data, and we have now collected more samples and analyzed more samples from the patient. It will be a more in-depth biomarker presentation at AACR. For the, you can say, data, what's needed? I do think that the data that we are currently generating and also will be generating over the remainder of the trial, that is the data that we need. What is also then important for, you can say, eventual transaction? That's definitely also there's a lot of people waiting to see what the data Merck and Moderna is going to generate is going to look like. Of course, here we were pretty encouraged seeing that Moderna was out at the TD Cowen Conference earlier this year saying that they are anticipating approval in 2027, hence continued good progress with their personalized cancer vaccine. I would not expect that one would need to wait until approval, but it will be interesting to see some of the early phase three data from that trial. That's clear that people are also awaiting that. I would say we have what I feel is needed from an EVX-01 point of view, and then there is some level of comfort confirmation that those data would also hold up in a larger scale later stage phase three trial, which we hopefully will see later on this year. Perfect. Regarding the ERV vaccines that you plan to work on, what types of cancers could potentially be the indications that we could use these vaccines to evaluate? Yeah. Really good question. We have worked with the 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 ERV burden, as we call it. That has led to the development of this precision ERV vaccine concept where we can see that in specific indications these sequences are shared across the patients. 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. The last question for 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 can 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 work plan that we agreed in 2023 that that's being completed. 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. As a reminder to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Thank you. 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. 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 will be focusing on delivering on our key milestones for the year. We are definitely looking very much forward to 2025 and will, of course, make sure to keep you all up to date on all recent events with Evaxion. 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.