Evaxion A/S (EVAX) Earnings Call Transcript & Summary

Greetings, and thanks for joining us on this H.C. Wainwright @Home Series. Today, we have a fireside chat with Christian Kanstrup, CEO of Evaxion; and Birgitte Rono, Chief Scientific Officer of Evaxion. Evaxion is a TechBio company which specializes in utilizing AI-based drug design to generate novel vaccines for both immuno-oncology and infectious diseases. In 2024, the company reported a positive 1-year follow-up data from its ongoing Phase II study of its neoantigen cancer vaccine EVX-01, validating the ability of one of its AI model PIONEER. Additionally, Merck, Evaxion's shareholder and partner since 2023 has been investing in the company, bringing up their interest up to nearly 20% in the recent transaction. So with the company's financial overhang removed, we want to discuss the development strategy not only in 2025 but beyond 2025. And for this, I welcome Christian and Birgitte to this fireside chat. So good day, folks. Glad to see you, and appreciate you accepting to talk to our audience today. So for starters, Christian, could you please tell us the strategy that Evaxion has been executing? And how do you folks see yourselves different from other TechBio companies that we know of.

Yes. No, first of all, RK, great pleasure to be here and always great to talk to you. So we really appreciate that. The way I see Evaxion, right, we are a pioneer in fast and effective development of AI-derived precision medicines. Core of our strategy, that's our quite unique and clinically validated AI immunology platform. And AI immunology, it can find targets and suggest vaccine designs that cannot be identified with conventional methods. I think also important to understand around AI immunology is it's faster, it's cheaper and more accurate and can be scaled for multiple different disease areas. In principle, we could target more than 100 different diseases with AI immunology and it can be used across different vaccine modalities. As such, the way we see the AI immunology platform completely revolutionized vaccine development compared to traditional approaches like, for instance, reverse vaccinology. And important also is it gets better and better the platform because iterative learning loops make sure that the platform keeps building on the aggregated learnings and improvements. What we also have been building around the platform, it's a full set of multidisciplinary capabilities from the early disease biology over the target discovery into a preclinical development, CMC, clinical development and of course, translational medicine. On top of that here, Birgitte and I are sitting at our site in Denmark. We have a state-of-the-art lab out here. We have an animal facility, which also means that we can do the full process in-house under one roof. And based upon this, we have been developing a broad clinical pipeline within cancer and infectious disease preclinical pipeline. And our focus, our strategic focus and our focus for value generation is both on the platform and on the pipeline. And it provides quite unique value creation opportunities, which we are pursuing via a multipartner approach. I think if we look at the differentiation element, I would say quite a few elements are differentiating us. I think one of the most important and it is probably that we were founded as an AI-first company back in 2008, i.e., long before there were any talk about AI, our 2 co-founders, they decided we're going to use computational methods to decode the human immune system, and that was in 2008. That also means that we have had 15 years or a long head start compared to many of the other TechBio companies out there today to refine and develop the platform. I think what also differentiates us, and we'll get back to that a little bit later, is we have a quite unique modular architecture of our AI platform which allows us to both focus on the platform and the pipeline in terms of value generation and that gives quite a lot of opportunities from a partnering point of view, but also in terms of building our own pipeline. So I mean, to sum it up, I would say we are a pioneer in fast and effective backside discovery, design and development. We are currently active within cancer and infectious diseases. But with a scalable platform, we could easily pursue value creation in other areas as well. And then we have this multi-partner approach, focusing both on the platform and the pipeline, and I think the transformative agreement we entered into with Merck in September 2024, is a great example of how we aim at pursuing value both via the platform and via the pipeline. And I think it's also fair to say that with the clinically validated platform we are at a super exciting point in time in the vaccine journey where our true value creation has only just begun. So quite exciting times here at Evaxion now.

Perfect. One of the driving forces of Evaxion obviously, has been the AI models that you have generated over the years. And currently, you have 4 different AI models that you have spoken about in publicly. These 4 are like the PIONEER, ObsERV, EDEN and RAVEN. So Birgitte, if you can -- would you mind describing these models? And what are the systems you and your team are using to validate this so that we understand how you're generating new molecules for clinical development.

Yes. So PIONEER and ObsERV that is the 2 AI models we use for identifying cancer vaccine targets. And PIONEER is the system that we use for designing our new antigen cancer vaccines. And as you mentioned, we have our lead program, EVX-01 in Phase II where we have used PIONEER to identify the patient-specific neoantigens that are being put into the vaccine formulation. And we have demonstrated that PIONEER is able to select immunogenic neoantigens with a very high position. So almost 80% of the neoantigens that we have provided to the patients in Phase II actually gave rise to an immune response. ObsERV is a more novel platform or model we have developed. We use it for identifying an alternative source of cancer antigens called endogenous retroviruses. It's these sequences that we all have in our genome that in normal tissue would not be expressed, but when cells are undergoing malignant transformation of becoming cancer cells these sequences are being expressed in the tumors. And that means that you can actually use them in a vaccine setting. So targeting the tumor cells that do have the expression of these sequences. And we have a novel concept, so precision cancer vaccine concept where we use ObsERV to develop vaccines that are broadly applicable, meaning that we can use the same vaccine for a broader range of patients. So going from the personalized approach, we've pioneered towards a more precision-based approach with this novel model. And then we have EDEN and RAVEN, we use EDEN to identify T cell antigens for our infectious disease vaccines, and we use RAVEN for identifying T cell epitopes also for our infectious disease vaccines. And we have several programs in the preclinical stages where we have used EDEN and RAVEN. So we normally do these predictions and then we start screening the antigens in the lab, finding the most promising antigens and putting them into the infectious disease vaccine population. So there is a big screening work done in the lab for these -- for identifying the most potent antigens for our infectious disease vaccines.

And just to add one comment here because you can say it might sound like a lot, that we have 4 different models, are we spreading our resources to too thin. I think that's important to understand that that's where this quite unique modular architecture of the platform comes in because we have 26 different building blocks. You should think about it as like small lego bricks and those are used across the 4 different models. So that means that it's not a uniquely built new model, and then we build another model. We take these 26 building blocks, put them together in different ways to give the desired properties. And this also means that whenever we are improving the performance of one of the building blocks it will automatically enhance the performance across all the models that it's being used in. So we have a quite scalable approach here where we're in a very cost-effective way can improve the performance. So it actually gives a lot of opportunities that we have this modular building block structure, both in terms of cost effectively improving the different models, but also in terms of scaling the platform. So while 4 might sound like a lot, it consists of the same building blocks.

To put these different building blocks in new ways, so assembling them for a specific purpose. So that could be that we enter into another therapy area, we can actually use what we have and then assemble the building blocks into new different models that are addressing that specific disease.

Yes. Great. So basically, you can kind of -- depending on what is required, you can utilize these models depending on the therapeutic category or the situation you are in, which is very beneficial. The other aspect, which I wanted to highlight with you, Christian, is over the year or almost 18 to 24 months that since you have come and being the CEO here at Evaxion -- with you and your management team, you've not only strengthened your balance sheet, but also have generated strong BD relationships. So in our eyes, it looks like the management has been successfully executing that part of the strategy really well. So could you tell us the overall strategy of how you have been approaching BD? And from here onwards, how do you want to take it forward in terms of making more of such relationships that you have generated so far.

Yes. No, I think, of course, it's fair to say that monetizing our platform and pipeline has been a key focus, which we shifted to for -- with a lot of focus early 2024 and started building structural plans around how to do that. We have had really good progress in that, which we are very pleased with, and it is not just the management team it's actually the whole organization because we kind of like told everyone earlier last year. Now everyone is in BD. It's about being out there talking about what we do and how we do it because, of course, the first step in being successful in business development is that, I mean, it might be that we think that we are the best in the world, but others should also think that we are the best in the world to do vaccine target discovery, design and development. And then we need to get that message out. So that there's been a lot of focus on communicating what we do, how we do it. And I mean, as you also know, we had an AI Immunology Day early last year, which was actually the first time we really talked about what can we do with the AI immunology, how have we built it up. And that's where it all started, getting the message across in a consistent way. And of course, we're very pleased that in September last year, as already mentioned, could enter into transformative agreement with Merck around both one of our existing pipeline candidates, EVX-B2 for gonorrhea, but also around the target discovery project that we entered into with Merck in September '23, which is a great example of what we want to do with our business development efforts. And then the way I look at it, right, focus when you do business development, that is on how you complement each other's competencies because ideally, whenever you do a business development agreement, 1 plus 1 should not become 2, but it should become 3. So it's important to have that focus on bringing in partners in the discussions where we can create opportunities for more effectively, faster with lower risk develop novel medicines together. And that is really the focus. And then we have this dual approach that we want to make partnerships both around our platform, i.e., doing new target discovery collaborations like the one we entered into with Merck in '23, but we also want to retain more value ourselves and bring certain pipeline assets into our own pipeline. Of course, we have EVX-01 as our most progressed asset in Phase II, but we also have a number of infectious disease pipeline assets that we are bringing forward. So you need that balance of doing the more platform-based deals which comes with, I would say, of course, lower initial upfront payment, but you have more capacity to do more because -- if you take, for instance, infectious diseases, then there are a vast number of infectious diseases where we can enter into target discovery collaborations -- so there's a higher quantity. On the other hand, of course, the later-stage assets, the further progress they are, the more attractive the near-term financials gets. And I want to have the right combination of a business development pipeline, which both focuses on pipeline assets but also around the platform. And I mean, I've been doing a lot of business development in earlier life as well. And what is important is, of course, having a fairly broad pipeline of potential deals with different types of partners. I mean we're talking both to pharma, we're talking to biotech. We're talking to other stakeholders because what is certain when you do business development. I mean, timing always tends to shift, priorities need to shift. So you need to have a sufficiently broad pipeline, and that's what we have been focusing on building up over the past year. And it's also fair to say that announcing the Merck agreement in September last year, that clearly led to an increased inbound interest in discussing what is AI immunology actually can do and has brought us in a quite good position in terms of our business development discussions. So it is focusing on complementing core competencies, but it's also very much focusing on having the right mix of potential partners in place. So we will continue that focus because it is about being able to monetize our platform and our pipeline. And we are best at doing the target discovery, design and early development. We are not the ones that are going to do large-scale pivotal trial for EVX-01 or bring a infectious disease candidate into a large-scale Phase II trial ourselves that I believe I can find many companies who are way better at doing that than we are. But on the other hand, I don't think there are many who are better at the early discovery part that we are with our AI immunology platform.

Okay. So I just want to ask one more macro question before we kind of go into the nuts and bolts of what you're doing. So as you know, we have had a change of government, change of policies to a large extent and also with RFK Jr. heading the Human Health Services. There has been a little -- not a little, a lot of talk about not being interested in vaccines and vaccine business. I know you're not truly in vaccine, vaccine business, but with cancer vaccines and vaccines against certain infectious diseases. How are you -- what have you been hearing from your potential suitors? And also, how do you approach your conversations now that the marketplace seems to be changing a little bit.

Yes. No. Let me start out by saying I think we have never discussed as much U.S. politics in Denmark and Europe in general as we do right now. Let me also be frank and say, I was a little bit sad when RFK Jr. was nominated back in what was that November because, of course, his attitude towards vaccines. And I think that that's created a lot of general debate, but also, of course, I agree with you, we are not in traditional vaccines. But on the other hand, there is a perception that a vaccine is a vaccine and hence, it's something that draws interest or attention, I would rather call it than interest. But I would say from our discussions with potential partners. I don't -- it has not changed the discussions. There are a general view, of course, we know this is a 4-year administration and things will change afterwards. So it's not something which changes, I would say, corporate priorities in any way. But of course, you can say, it creates a bit of turbulence from general public communication point of view, when you have views being closed, which differ from yes, many other views. So we are trying to navigate through it. I would think -- say the good thing about being an early-stage clinical company is that we are -- we are not affected by all the discussions about customs and tariffs and what you have like some of the more mature companies. So at least that's one less thing to worry about. But it's definitely clear that it is about navigating through what is noise, what needs to be explained. And it's also about keeping the long-term view, and that's what we are doing because, ultimately, I do believe that science will prevail. And then with the areas we are in, where there are significant unmet needs I do not worry too much about it, but it is, of course, creating short-term turbulence, but I am a great believer in having data speak for itself. And ultimately, I believe that will also prevail. I don't know, Birgitte, if you have views here.

No. Maybe we could also put the time into perspective. I mean it takes more than 10 years to develop a novel therapy and as you said, the administration in the U.S. that runs for 4 years. So -- yes.

Okay. So let's get into the fun part of the conversation. So Merck has been an excellent partner for you folks since probably a conversation started earlier than 2023. But since 2023, at least we know that they have been an excellent partner for you folks. So recently, they have also increased their equity interest to nearly 20%, as I've said before. So just to start off, what makes companies like Merck get attracted to you? What is it that you are offering? I know a few minutes ago, you were saying that I like to offer different things for partners. So what is it that is attracting such companies to you?

First of all, of course, we are very pleased with the collaboration we have with Merck. Now the Merck Global Health Innovation Fund, they have invested in our last 3 offerings. And in the one, the public offering we did late January, they actually brought their ownership stake to just below 20%. And then, of course, we have the R&D collaboration and the optional license agreement with Merck Research Lab. And then we actually have the [ pembro ] supply agreement for EVX-01 which stays -- yes, further back. So we have a very good relationship with them and are very pleased with that. It's clear what the interest is, of course, our ability to develop novel vaccine candidates in an area with high unmet needs and where no vaccines are available today. And then it's also clear that our ability to move fast. And the fact that we have this multidisciplinary capability set and the lab and the animal facility which quickly allows us to generate data on antigens identified by the platform that is attractive to companies like Merck. So I think it's a broad-based interest both in the broader capabilities, but it of course, all starts with our ability to identify the right vaccine target and validate these. So super excited about the collaboration, and they are very supportive as a partner as well.

Okay. So in terms of the collaboration with Merck, you alluded to it a little bit regarding the option exercise that they could be taking. So this is on the development of EVX-B3 where we have been collaborating with them. So what is EVX-B3 to start off? And also, what's the status of that collaboration not only in 2025? And the third question within that is, what is the trigger point for Merck to make the decision to exercise their option for development of EVX-B3?

Yes. So EVX-B3 is vaccine against an undisclosed bacterial pathogens, we've not talked about what type of bacterial is, but it's a pathogen for which no approved vaccine exist. And we do see rises in the number of infected people. So there is definitely a high medical need for developing novel treatment solutions for this pathogen. So under the collaboration agreement with MSD, we have used AI immunology for identifying relevant targets, so antigens -- and currently, we are doing experimental validation of these antigens. So the collaboration is on track, and we are -- right now, we are in the last phase of the experimental validation. So the expectation is that MSD will make their decision in the second half of this year. And we have upfront agreed to the data package that they will make their decision on. So I think we cannot disclose more than that.

But we can say it's on track compared to the plan that was laid out when we executed the agreement because, of course, that was important for us to know exactly what's the time line that we are operating with. And also, as Birgitte said, what's a data package that will trigger an exercise of the option.

Very good. And so I believe just on EVX-B3, if they exercise that option, you get a $10 million milestone payment. Is that correct?

No, the way the agreement is structured is if they exercise both B2 and B3, we get $10 million. If they only exercise one, we will get $7.5 million. And that doesn't matter whether it's only B2 or B3 it's $7.5 million for one and then $10 million for two.

Okay. So let's try to understand what is the EVX-B2 then. So what is it? And is there a time line for that, too, in terms of when you need to deliver a data package or is it an open-ended timing?

Yes. So EVX-B2 is our vaccine candidate against gonorrhea. We have worked on this for several years. It's a protein-based multi-component vaccine that we have designed with AI immunology. And we have a pretty strong preclinical data package, and we have demonstrated that EVX-B2 protects mice against gonorrhea. And further, we have shown that 50 different clinically relevant gonorrhea streams are susceptible to EVX-B2 mediated immune killing. So what is under this agreement or collaboration is that MSD is currently doing a few validation experiments. So basically confirming our key findings. And we have provided protocols and gonorrhea strains and samples from our experience so they can conduct these analysis. And so far, these activities are also on track, and we expect a conclusion in the second half of this year. So basically, at the same time of the B3.

So you can say, time lines for both B2 and B3 are aligned. So a conclusion will be reached at the same point in time.

Okay. Perfect. So moving on to the rest of the infectious disease portfolio. Just to start off, even though vaccines are being shunned, in this country. But at the same time, we are seeing a huge -- not a huge, but certainly an influx of measles and also a bird flu, which is kind of not only impacting humans but also impacting the economy at a different level. So do you think AI model such as yours that you have can generate vaccines? And actually, is that something that you folks are thinking of? And would that be a viable opportunity at all for you folks?

So as we talked about, EDEN it's our AI model for identifying B-cell antigens, and RAVEN is the model we use for identifying T cell epitopes. And we strongly believe that if you combine these 2 models and design a vaccine that contains both B and T cell epitopes, we would be able to create a very efficacious vaccine. We also know that these 2 models are broadly applicable, and we have used them to identify targets for both bacterial and viral and parasites. So I don't see any limitations in terms of the pathogens that we can tackle with these 2 models. But the specific infections that or at least the outbreaks that you're talking about, there is actually a pretty efficacious measle vaccine. And I think the numbers that you're seeing in the U.S. is a reflection of the fact that not all people are vaccinated. It's not because there are new strains coming up. So I'm not sure that we would, as an internal focus, develop a novel measle vaccine, but we can definitely develop vaccines for other pathogens where there is an unmet medical need and where the current treatment options are not sufficient, for instance, where there is antibiotic resistance strains or even further increase in the cases. And the discussions we have with potential partners also has a pretty broad range of pathogens that they have interest in. So we don't see any limitations in terms of the applicability of these AI models.

Okay. So among these -- within the portfolio of yours, there's another molecule EVX-B1, which is a preclinical vaccine against Staph aureus, which is, I believe, derived from the EDEN model. So large-cap pharmas like Merck, GSK, Pfizer are all attempted to develop preventive vaccines against Staph aureus. But obviously, nothing has been successful and have come through to the market. So how do you think EVX-B1 is differentiating itself against what the products that have come through the clinic before. And also, Staph aureus has been an issue, not just here but everywhere. And what's the potential for a partner to come in and develop that along with you folks?

Yes. No, it is absolutely correct that vaccines against Staphylococcus aureus have historically faced some challenges. Some were actually leading to severe side effects and some were just not efficacious. And I think several factors contribute to these outcomes. Staphylococcus aureus is a complex pathogen. It has immune evasive strategies and it has a complex pathogenicity. And further, the choice of antigens that these companies did was maybe not optimal, and we have done a different approach where we have included, as you said, novel in identified antigens as well as proprietary design well-described antigens. And we have looked at where are the soft spot in this pathogen so tackling it from multiple angles. And we have included in B1 toxoids and [ viral infectious ]. We also have a very strong preclinical data package that I think is beyond what the other companies had before entering into the clinic. We have, of course, mouse data, but we also have data from a large animals or nonrodents in this surgical site infection model. And that, I think gives us confidence that our B1 vaccine would have a success in clinical trials.

So I would say in general, I mean, we are pretty optimistic around partnering potentially. I think we -- especially we got a little bit delayed in the partnering because we were doing some large non-rodent animal studies with a potential partner who then decided to exit the infectious disease area. And that meant that there was some delay in getting the broader partnering activities growing, and that's what we are focusing at now.

Okay. So beyond the vaccines that we discussed, B1, B2 and B3, are there plans to expand that portfolio of infectious disease vaccines. And if so, would we be hearing of any of them in '25? Or is it going to be '26 and beyond?

So as Christian mentioned, our strategy is, of course, to enter into partnerships -- and we do anticipate that some of the vaccine candidates that we have developed ourselves that they will be out-licensed during this year. So we need to create a novel or new ID vaccine candidate pipeline. And we have a lot of discover activities ongoing in the company that we can decide on maturing further. So we do have an ambition of starting 2 new ID projects and one could be -- or it could be your own programs or it could also be target discovery collaborations. But one in the first half of the year and one in the second half of the year is the ambition.

Very good, very good. We'll be on the lookout for them. So moving on to the immuno-oncology part of the pipeline and the company. So as we started off this conversation talking about EVX-01 and PIONEER model. So what's the unique entity of PIONEER AI model. And so in targeting neoantigens that specifically have been validated in the clinic has helped to enhance patients' antitumor immune response. So in your opinion, what are the potentials and challenges of this sort of an approach?

Yes. So these individualized cancer vaccines, they are tailored to the individual patients, meaning that -- we design a vaccine for each and every patient that is enrolled in our trial. And we do that based on a tumor biopsy and then on a healthy sample. So we can look into the tumor mutational profile and then tailor the vaccine towards those specific mutations. That is a pretty complex process, and we have developed PIONEER, but then in a very automated way can select the most relevant new antigens from. Basically, the input is sequencing data from the patient. So -- and we know that, of course, other companies are working within this field. We have the Moderna-Merck collaboration, and they are a little bit ahead of us at least in terms of clinical development, but across the field, we do see promising clinical data and also strong immune responses. The challenge or at least what is more complex is the supply chain. So you need -- for every patient, you need to manufacture a new batch that is tailored to that patient. We have been able to manufacture our vaccines within 7 weeks from biopsy collection to immunization of the patient. And we know that this turnaround time can be further optimized and also scaled similarly to what has been achieved in the CAR-T field. So I think there will be options for further optimizing these processes. We have done a global shipment, et cetera. So if you can house the manufacturing process under 1 roof and get the samples to the manufacturing side very fast then I think we can go way beyond the 7 weeks.

Very good. As we talked about the EVX-01, you have generated strong data both during Phase I and Phase II clinical studies. So could you walk us through that data? And what do you think either you or a partner along with you would -- could be doing with -- not only with the data, but also how to progress from here based on the strong data that you have?

Yes. So EVX-01 is our most advanced program, as mentioned, we are currently in Phase II. It's a vaccine that we have developed for first-line treatment of advanced melanoma, but we also see the potential in other solid cancers for this vaccine. EVX-01 contains multiple targets. So these new antigens that we identify with AI immunology based on this sequencing data. And we concluded on a Phase I study in late '23. And in this study, we demonstrated an overall response rate of 67%, which is pretty high compared to just standard of care, which is for these patients anti-PD-1 therapy. We could also show that EVX-01 induced a new antigen-specific T cell response in all of the patients in the trial, and there are no side effects related to EVX-01. And then in the Phase I study, we also saw that the clinical response correlated with a pioneer score of the new antigens. This means that -- our AI system is actually able to identify the new antigens in the patients that are also linking to clinical response. And then based on this promising data, we initiated a Phase II study. And in September last year at the ESMO Congress, we reported 1 year interim data from this trial. And here, we also had a pretty impressive overall response rate, a little bit higher than in the Phase I of 69% of the patients actually had a response according to the RECIST criteria. And again, we could see that EVX-01 could induce a specific T cell response in all of the patients. And when we look at all of the new antigens that we have administered almost 80% of the selected new antigens induced a specific T cell response. So this underscores the accuracy or position PIONEER in selecting the relevant new antigens. And again, we could see that EVX-01 was well tolerated, confirming the findings of the Phase I study. So we are looking forward to the next data set coming out. The 2-year readout will be in the second half of '25.

Very good. So it is really encouraging to see PIONEER AI generate a neoantigen vaccine. And also, as you said, 8 out of the 10 new antigens actually gave a functional T cell, which is really exciting because -- this is against the background where neoantigen vaccines have not really kind of been as successful as they were expected to. At the same time, do you see that this data set is actually helping people take a fresh look, not only at neoantigens, but also to see how they can take advantage of a pioneer AI model? And are you folks seeing more number of incoming calls on this -- on this model to initiate a relationship and that can end up in a partnership with you folks.

I would say there's no doubt there's a very strong scientific interest in the concept of personalized cancer vaccines. And I think everybody agrees that precision medicines, including personalized cancer vaccine will become a therapeutic option in the future. I think it's also clear that personalized cancer vaccines, I mean, as a concept, it is something which also brings a little bit of complexity from a supply chain point of view, even though as Birgitte has mentioned that, that can be addressed. But to that extent, I think it's also -- they're preferable to have the most possible and the strongest possible data before really engaging in partnering discussions -- and hence, you say the way I look at it, we need to make sure we have the right package before really, really engaging given that there are -- it's a novel concept, and there are certain issues that need to be put aside. But I would say, of course, there is good interest in the PIONEER and ObsERV for that sake. But I think it's also fair to say that where the scientific interest is there, we still need to move the business side of things a little bit from a partnering point of view with data. And of course, also, people are eagerly looking at what is Merck and Moderna are going to bring out of data when they have the first readout from the Phase III. So we are focusing on continuing generating the strong data that we are seeing and then, of course, have a broad focus on discussing with potential partners along the way, right waiting for the 2-year data.

Okay. So the other model, which is also equally exciting is the ObsERV within the immuno-oncology space. So I know that you've been working on a clinical candidate -- and how close are you in terms of nominating a clinical candidate and to initiate some preclinical/clinical work on that candidate.

Yes. So we have developed this novel precision cancer concept, utilizing this novel class of antigens, as we talked about before, so-called endogenous retroviruses. And these sequences are expressed in cancer but absent in normal tissue, making them attractive as cancer vaccine targets. We also know that these sequences are shared across patients, and that allows us to design precision cancer vaccines that can be broadly applied. So meaning that you don't need to produce a single batch per patient. And we have used our most recent AI model observed for designing these vaccine candidates. We are in the process of nominating our first clinical candidate, and we do generate a lot of data currently in the lab and -- in the second half of '25, we will share more insights on this very nice concept.

Very good. So going -- so in terms of what to expect from the pipeline and also in terms of catalysts over the next 12 to 18 months, which ones would you folks highlight?

Yes. No, I think it's fair to say that we have a super exciting year ahead also looking into 2026 for that sake. But if we focus on 2025, I mean, from a pipeline point of view, of course, we have the EVX-01 Phase II, 2-year readout, which is going to be super exciting, given our EVX-01 have continued to deliver a very strong clinical data. And then as Birgitte just talked about the lead candidate selection for our precision vaccine concept is going to be exciting because that's going to open up a new opportunity space for us. And then we already talked about the 2 new infectious disease candidates coming into the pipeline this year. So from an R&D point of view, several exciting things coming up. And then there's, of course, a whole business development view on things with very importantly and also super exciting Merck potential option exercise in the second half of the year, bringing up to USD 10 million. And then we have also communicated in our 2025 milestones that we expect to do at least 2 new business development agreements for the year. So I think we will be -- or we are already busy, but hopefully, we'll also be busy announcing some key milestones here. So a lot of exciting things coming up over the time ahead.

Very good. And so as I started off this conversation now that you really don't have a financial overhang, so to speak, at least for the next 18 months or so, how -- so what does that allow you to do both in the clinic, in the preclinic. And how do you -- how should we, as investors, think about -- think about growth without that financial overhang on you. And also just for closing, how -- what should investors expect from Evaxion.

No, I think, first of all, I mean, it has been really nice removing that financing overhang that we have had. And I mean, in our latest filing from January that we had around $12 million in cash brought in another $11 million. So -- now we have cash into mid- '26. And, if say, Merck exercise the option, we get $10 million, then we have cash into 2027. So what this allows us to do is, of course, having full focus on executing on near-term plans but also discussing what are the value creation opportunities that we see for the longer term and that we already kicked off some weeks ago after completing the financing and are in the process of designing that and hopefully be able to communicate something later on in the year. But of course, clear with the scalability and the opportunities that AI immunology brings, we need to look at how can we continue to generate value for shareholders not only short term, medium term but also for the longer term. And it's a lot of opportunities. I say I also believe in having the right focus and growing from the core, and that's what we are focusing very much on doing now, but clear with the financing overhang removed and being in a good position, both from a cash at hand, but also potential future cash coming in, that gives us opportunities to plan for the longer term, which is ultimately what you should do when you want to continue generating strong shareholder return. And ultimately bring the company in a position where we are on a consistent basis, cash positive. So that's been truly exciting to transition into that next phase where we have the foundation in place. We have the pipeline of best development opportunities and then we are in the longest situation that we have an R&D pipeline, which is super exciting and have delivered strong data so far, and we're excited about what to bring from the pipeline in the time ahead. So I think we're in a good spot, and it's exciting to be able to look a bit further ahead and also how we want to create value not only tomorrow, but in years from now.

Thank you, Christian and Birgitte for participating in our H.C.Wainwright @Home Series, and looking forward to talking to you soon. Thank you, and good luck.

Thanks for having us.