Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Full Year 2025 Financial Results Webcast and Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please go ahead.

Thank you, and good morning, everyone. Thank you for joining us for Evaxion's business update following the reporting of our 2025 full year financial results yesterday. And apologies that this call is 24 hours later than we anticipated for technical reasons, we are delighted to be here today. My name is Helen Tayton-Martin, and I am honored to be leading this call for the first time as Evaxion's CEO. We move to the first slide. Okay. So on today's call, we will review the achievements of 2025 and touch on the milestones we anticipate for 2026. Our Chief Scientific Officer, Birgitte Rono, will then walk through our key R&D updates for the year, including the latest innovations from our AI immunology platform, after which our CFO, Tom Schmidt, will walk through our 2025 financial results before we close with a few concluding remarks and take questions. Right. Moving to the next slide. And of course, our comments and presentation today may contain forward-looking statements and all references on today's call, I'll refer to our filed SEC statements and specifically, our most recent 20th annual report for 2025 -- 2025 filed yesterday. So moving to the next slide. I will start with our 2025 achievements and our 2026 milestones. In 2025, we were very pleased to report tremendous progress across all pillars of the company. First of all, in business development, we were delighted with the progress in our collaboration with MSD and our infectious disease portfolio, with the decision by Merck to exercise its option over our EVX-B3 program candidate. Whilst the target for this program is not disclosed, we are very proud that this represents the first in-licensing to our knowledge of an infectious disease vaccine candidate identified and validated to an AI discovery platform. Whilst MSD chose not…

Thank you, Helen. So 2025 marked a turning point with significant advancement across our R&D pipeline and also and our AI platform. And additionally, as Helen alluded to, we also entered into the in-licensing agreement with MSD on the EVX-03 program. So our 2025 focus has been on strengthening our platforms predictive power, maturing key R&D assets and are building the foundation for future partnerships. So the 2025 achievements position us well as we move towards the data with milestones in 2026, that Helen just presented. So with that, I will begin by walking through individual key programs and platform development. So next slide, please. [ EVX-01 ], our personalized peptide-based cancer vaccine in advanced melanoma continues to deliver strong clinical data. So our 2-year Phase II data presented at an oral session at ESMO in October showed strong clinical outcomes, including a high objective response rate of 75% and complete response rate of 25%. Notably, 92% of the responders remained in response at this 2-year mark. Key biomarker data included the very high [ immunogenicities ] rate with 81% of all the individual new antigen administered across patients, giving rise to a specific T-cell response. So this very impressive heat rate outcompete data from similar programs conducted by others. And this truly underlines the precision of our AI immunology platform, to identify better than vaccine targets. Two key milestones are expected for this program, as Helen also alluded to, additional biomarker and [ genicity ] data expected in the first half of '26, and we also plan to communicate the 3-year data from a subset of patients that are currently in expansion part of the Phase II study, and that will be reported in the second half of '26. So importantly, we aim to conduct future trials in partnership…

Yes. Thank you, Birgitte. And also a warm welcome from my side to our call today. And I will now walk you through the financial results for 2025. So turning to the next page. We have, throughout 2025, been really successful in expanding on our cash runway and also strengthening on our equity side. This has happened throughout the year through public offering and the use of ATM we did in January, followed by the MSD exercise fee and the ATM used in September. And furthermore, the exercise of investor warrants from our January offering in October and November, all summing up to a cash inflow of USD 32 million. Furthermore, as also shown on this slide, our EIB debt-to-equity conversion done in July of USD 4.1 [ billion ]. We've reduced certainly our cash -- future cash out and thereby certainly also expanding and extending our cash runway. And finally, with our filing in December of our prospectus supplement regarding our ATM. It has now created us with further flexibility ability and options as we move forward with expanding our pipeline and platform also. So really, really underlines the strong execution throughout the year. And turning to the next slide. that also leads into the highlights of 2025, where we really have delivered on all the targets that we set and we are progressing towards our aim of becoming a sustainable self-funding business. Both revenue and costs have improved while at the same time, we are continuing to invest in our platform and in our pipeline programs. As just mentioned on the previous slide, activities and execution of the MSD deal, the EIB debt conversion, our ATM and capital market activities have not only improved our cash position and runway, but has also significantly strengthened our equity. And with…

Thanks, Thomas. And just moving to the last slide. In summary, 2025 was a year of strong operational momentum for Evaxion, in which we achieved several key milestones. Overall, we strengthened the business considerably to the validation of our strategy with our AI-Immunology platform, delivering on both data and partnerships. This, in turn, has enabled us to both strengthen our financial position and consolidate our position as a leader in AI-based of discovery, design and early development. With a number of potential partnership discussions ongoing, we are already funded into the second half of 2027 through the financial milestones achieved in 2025. So we're in a good position to move forward through 2026. With that, I'll hand over to the operator for questions.

[Operator Instructions]. Our first question today comes from the line of Thomas Flaten from Lake Street Capital Markets.

Maybe to start broadly, Helen, you've been in the seat now for a few months. I'm just curious if you could provide some overarching commentary on what you have implemented or are going to implement -- any changes in strategy? And any bigger picture notes like that, that could help us with the context of your tenure?

Sure. Thanks. Thanks for the question. Yes, I joined at the end of November last year. So the last 3 months have flown by. But I already have a strong impression from my prior seat on the Evaxion Board. In terms of bigger picture, changes. I think the fundamental action remains really strong. And in fact, I think they have only got stronger through 2025. So the ability to have an AI platform that is built up over many years, many iterations, grounded in data and testing for that data in the lab, and ultimately in the clinic has really strengthened the core offering. So I remain really excited about the power of the platform in the oncology space and also in the infectious disease space. And I think we're sort of seeing a lot more traction around what we can do with the platform now from external engagement. So I think the fundamental strengths and core of what Evaxion has to offer is even stronger now than potentially before. And I think in a world of AI, everything, actually getting to products, actually producing candidates that can generate vaccines that generate a biological response and the clinical response is meaningful and is becoming recognized as meaningful, certainly in our partnering conversations, et cetera. So I think that, that is core. So clear observation I had before coming into the company and certainly strengthened by all my observations within it. and even more impressed by the team that's in place that can deliver on this. I think in terms of the overall strategy, what have Evaxion has done well is that early discovery, the early validation, that deep scientific and informatic embedded expertise, and we can certainly bring things forward into early clinical development, late preclinical, early clinical. And I think what we're going through at the moment is a process of really optimizing where we see the most value in the near term, both in terms of our oncology assets, but also within the infectious disease area. I think we are not positioned to take too much further forward into the clinic. So we've been very cautious about that but we certainly see strength in getting interest from external parties around the assets that we've already got. And actually, the capability of the platform. So there's not a fundamental change to strategy, but I think a sharpening and the deepening of focus around the assets that will have the most value. I hope that's helpful.

Yes, that's great. And just keying off of your last comment there about taking products into the clinic. You mentioned with EVX-04 in Birgitte's presentation that you would be looking to submit regulatory paperwork. Is that a product that you think you have to take into Phase I given that herbs are a bit new, a bit different in order to attract a partner interest?

I think that's a very good question. We are certainly preparing to take it into the clinic, and we believe that we can do that to gain some initial proof of concept. There's a lot of interest around the platform at that particular metacandidate antigens in the vaccine. I think we're doing some further validation, which I think will continue to strengthen it. So the answer in short is not necessarily, but clearly, the more critical validating data that we can add to the package. The stronger the value proposition to an external partner, and that's obviously what we're all about is maintaining the -- building the value for as long as we can to strengthen our position. And I think we're very confident about what we can do with it preclinically and potentially clinically.

Our next question today comes from the line of Michael Okunewitch from Maxim Group.

Congrats on all the great progress you made. I guess to start off, I'd just like to see if you could comment a little bit on the partnering efforts for EVX-01. And in particular, if there's anything that you've heard either in your feedback from partners that you think you're still would be particularly important for us to watch for from the upcoming data releases, whether that's the 3-year data or the biomarker immunogenicity. Is there anything in particular you think is key for driving these partnering discussions?

So that's a really good question. And I mean, clearly, the cancer vaccine space has had something of a checker passed -- way back, but more renaissance, I think, in the checkpoint era. And I think our data is certainly resonating with companies who are interested in the cancer vaccine area, understand the nuances around getting, I think, strong cancer -- antigens, [ presliced ] cancer antigens for not just immune recognition but for clinical benefit. So the -- it is a complex therapy to administer, but it is also potentially an effective therapy. And I think the sorts of things that gain interest of the -- not just the response rate that we've seen in 2 years, 1 year than 2 years at ESMO, but also the recognition of the antigens, the numbers that the [indiscernible], and I'll ask you to add comment to this as well. So I think the -- we're in a strong position with that updated clinical data package that we have, the translational data, I think it's going to be interesting. It continues to -- so why and how the immune response is happening in parallel to the clinical response. So that is, I think, a differentiator and also in the population, the advanced population rather than adjuvant melanoma population. And clearly, I think we're also seeing interest in this whole approach in other high mutational burden cancers too. So beyond melanoma knows of it. I think those are the differentiators thinking about where else this is applicable accolading the different biological parameters, the translational insights that we're seeing that's somewhat different to how others have reported on this with similar approaches. So quite a bit of interest. I think the number -- to be honest, a number of companies are on the fence, but we're looking with interest and very interested in the shared approach -- the share approach that our EVX-04 program offered. Birgitte, do you want to add some further comments?

So there's no doubt that the ability of our AI immunology platform to identify the relevant targets and is getting a lot of interest from potential partners and also from the academic community. And with this 81% hit rate, as we call it, I think this is very impressive. We have, of course, looked at other similar programs and seen that most of them are reporting hit rates way below 60%, meaning that the antigens that they are including in their vaccines are not all able to induce a specific T cell response. And this is, of course, a testament to the position of our platform. So that's one of the key elements. And another point that I would like to make is that we do see EVX-01 as not just a therapy for advanced melanoma. We believe that the same concept can be very useful in other occasions where there are a high mutational burden, meaning that there are several antigens to choose from. That includes many of the high prevalent cancer indications. It could be non-small cell lung cancer and also some of the colorectal cancers.

Thank you. I appreciate that additional color on that. And then as a follow-up, I wanted to ask if you could provide a bit more color on how you're applying the AI immunology platform to autoimmune disease. You identified this as a new area of interest. And do you expect that this would be more focused on allergies? Or would you focus more on the major large autoimmune and inflammatory diseases. Any additional color you could provide on that would be helpful?

Sure. I think the first thing to say is it's early in terms of our prioritization of the indications, but we've certainly done some work around that based on parameters, which I'll -- Birgitte you're happy to comment on that, I think, high level in terms of what's guiding where we focus will be -- that would be good.

Yes. So we have done a lot of analysis on most prevalent autoimmune diseases, and we do see a clear fit for our platform. I mean, we, of course, need to further improve it and build a few additional smaller unit that allows us to apply the immunology. But we do have many things in place that can be directly applied in this area. So we will, of course, share more when we have done both analysis on which key indications we will pursue and also when we have done a little bit more work on adjusting AI-immunology, so it fits these diseases. But we should remember to say that there's a lot of these smaller units we call them building blocks that we can directly apply for these tax of diseases. So not only for autoimmune diseases but also for other diseases where there is a strong immunological component. So of course, we need to build a little bit, but the majority is already in AI-Immunology.

Our next question today will come from the line of RK from H.C. Wainwright.

Thank you. This is RK from H.C. Wainwright. Just to start off, Helen, a quick question for you. You have basically, we've been an architect and multibillion dollar balances at that [ immune ] especially the large deal that was transacted with GSK. And also, you have heard a lot of experience in transactions. And while Evaxion is technically a very strong company, they have always had a difficulty in translating that language into meaningful transactions. Of course, Merck is a pretty strong partner. Based on your experiences, and how you manage to translate that. What sort of discussions could you have at this point? especially when talking with large-cap pharma, I'm convinced them that an AI tools predictability is as good as a physical assay and get them to start looking into some of the products that Evaxion is generating.

Thanks for the question. I think there are probably multiple dimensions to answer that question to the extent that it is possible to answer it at this point. One is that A lot of this is to do with timing. It's to do with data that validates that it's more than a sort of an AI platform. And I think actually, the fact that we have the scope to validate and iterate candidates target discovery with candidate development with cancer validation is something really novel that we're generally out there. And when I said timing -- there are obviously many of the large pharma, most of them will all have in-house AI platforms running in one form or another. But I don't think there are many that have got this sort of integrated long sort of longitudinal depth of expertise that actually has. So really, is that this is about crystallizing the offering through the validation of the cannabis we have and sort of being in dialogue with the right people. And you mentioned my background was a long time, 17 years in my precise company, building relationships establishing contact, understanding and listening to strategy, looking at the wider picture. These are all things that are very much part of how deals get done. And ultimately, it's down to relationships and credibility and really having something that fits the need. And all I can say at this point is we're reworking up some of those approaches and some of those themes in terms of how we are approaching potential partnering interaction, I have to say that the action team is well known with quite a few of these groups, but we're building and expanding that profile. And I think that's critical to the future success in partnering conversations. So it's being what you say you are in front of the right...

Perfect. Then going into relationships with Merck, especially regarding EVX-B2, Merck decided to extend the evaluation of the molecule rather than exercise the option at this point. Is this a function of them trying to do additional experiments or functional assets? Or are they requesting from new additional work so that they can come to a conclusion?

Sorry, are you referring to the extension that they had last year before the opt decision there?

Yes, yes.

I mean we can't really comment on, obviously, the combination nature of the interactions. All I can say is that sometimes is sort of R&D programs when they are back and forth and shared between organizations don't always run to plan. And so sometimes that requires looking at things again. But ultimately, then there are time frames around things, which have to follow through. So I think there are reasons for not taking sort of obviously, their reasons not multidimensional. All I can say is that we remain really excited about the data. We actually continue to build data on the program internally throughout that period of time as well. So we feel very, very bullish and strong about the data package but how and why I wanted to do that work? Or is it something we probably we can't really add any more commentary on.

Okay. On the EVX-01 durability, Birgitte, so you have shown 92% of the responders showing sustainability, be it 24 months. As we are looking forward to the 3-year durability what sort of exhaustion markers are you going to be tracking so that we understand how well the durability is.

Yes. Thank you for that question,. So it's correct that 92% of the responders remained in response with this 2 year mark. And I guess your question was related to the T-cell extortion -- as yes, we do a deep scar profiling, looking at activation marker, extortion markers and also at different phenotypes of the T-cells, so including CD4, CD8, but also looking into whether there are regulatory T-cells coming up. And so far, we have demonstrated that -- the profile of the T-cells are very favorable. So in more of the activation or effective type of sales and not too many that are having exhaustion markers. We also see that there's a like dominance of CD4 T-cells and with some patients are also mounting a CD8 T-cell by time. So we have -- during this extension phase of the study, we have been collecting additional blood samples that are currently being analyzed in our lab. So not to comment on that, but it's very exciting. And since EVX-01 is giving us a immunotherapy in this extension phase, we're also very curious of understanding what EVX-01 can drive on its own without having the background of the checkpoint inhibitors.

Okay. One last question from me. This is on the EVX-04...

In the interest of time, we will move to our next question. And our next question comes from the line of Daniel Ben Hill from Jones.

On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates?

Thanks for the question. I mean it's early, and we probably cannot provide more details. But, Birgitte, do you want to comment on how we think about it.

Yes. So the first step is to settle on an indication. So we have done landscaping. We've done dianalysis on looking at the top 10 most prevalent ultimate diseases, and we are now narrowing down which one could be the most, I would say, interesting from a -- from our perspective, where there is a nice fit for AI-Immunology. And so that work is ongoing. We've almost completed it. And next step is to focused on building the additional smaller units that we will be needing in AI immunology to enable us to develop therapies for these diseases. And in parallel, we are also sitting on mouse models in our lab, so ensuring that we can also test the candidates that AI-Immunology is designing. So that is the current plan. So pretty traditional way of analyzing our existing the candidates that AI immunology is designing.

Thank you. This concludes today's question-and-answer session. I will now hand the call back to Helen Tayton-Martin, CEO, for closing remarks.

Thank you very much for everyone participating on the call today. It's been a great year of 2025 of transforming the company for Evaxion delivering on multiple milestones, leaving us in a stronger financial position than for some time, where we hope we can take the company forward and deliver on our 2026 milestones and continue to strengthen the value that comes from the platform and the asset. So thank you for your questions and your engagement, and we look forward to our next update. Thank you. Bye-bye.

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.