Greetings, and thanks for joining us on this H.C. Wainwright at Home Series. Today we have a fireside chat with Christian Kanstrup, CEO of Evaxion, and Birgitte Rønø , Chief Scientific Officer of Evaxion. Evaxion is a TechBio company which specializes in utilizing AI-based drug design to generate novel vaccines for both immune. Greetings, and thanks for joining us on this H.C. Wainwright at Home Series.
Today we have a fireside chat with Christian Kanstrup, CEO of Evaxion, and Birgitte Rønø , 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 one-year follow-up data from its ongoing Phase 2 study of its neo antigen cancer vaccine, EVX-01, validating the ability of one of its AI models, 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 a recent transaction. With the company's financial overhang removed, we want to discuss the development strategy not only in 2025, but beyond 2025. For this, I welcome Christian and Birgitte to this fireside chat. Good day, folks. Glad to see you and appreciate you accepting to talk to our audience today. 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?
Yeah. No, first of all, RK, great pleasure to be here and always great to talk to you. 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 it, the AI-Immunology platform completely revolutionized vaccine development compared to traditional approaches like, for instance, reverse vaccinology.
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 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. Based upon this, we have been developing a broad clinical pipeline within cancer and infectious disease preclinical pipeline. Our focus, our strategic focus and our focus for value generation is both on the platform and on the pipeline.
It provides quite unique value creation opportunities, which we are pursuing via a multi-partner 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 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 two co-founders, they decided we're going to use computational methods to decode the human immune system. 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. That gives quite a lot of opportunities from a partnering point of view, but also in terms of building our own pipeline. I mean, to sum it up, I would say we are a pioneer in fast and effective vaccine 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. We have this multi-partner approach focusing both on the platform and the pipeline.
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. I think it is also fair to say that with the clinically validated platform, we are at a super exciting point in time in the Evaxion journey where our true value creation has only just begun. Quite exciting times here at Evaxion now.
Perfect. You know, one of the driving forces of Evaxion obviously has been the AI models that you have generated over the years. Currently, you have four different AI models that you have spoken about publicly. These four are like the Pioneer, ObsERV, Eden, and Raven. Birgitte, if you can, would you mind describing these models and what are the systems you and your team are using to validate these so that we understand how you're generating new molecules for clinical development?
Yeah. Pioneer and ObsERV, that is the two AI models we use for identifying cancer vaccine targets. Pioneer is the system that we use for designing our neo antigen cancer vaccines. As you mentioned, we have our lead program, EVX-01, in Phase 2, where we have used Pioneer to identify the patient-specific neo antigens that are then being put into the vaccine formulation.
We have demonstrated that Pioneer is able to select immunogenic neo antigens with a very high precision. Almost 80% of the neo antigens that we have provided to the patients in Phase 2 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 transformations or becoming cancer cells, these sequences are being expressed in the tumors. That means that you can actually use them in a vaccine setting, targeting the tumor cells that do have the expression of these sequences.
We have a novel concept, a 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. Going from the personalized approach with Pioneer towards a more precision-based approach with this novel model. We have Eden and Raven. We use Eden to identify B cell antigens for our infectious disease vaccines, and we use Raven for identifying T cell epitopes also for our infectious disease vaccines.
We have several programs in the preclinical stage where we have used Eden and Raven. 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 formulation. There is a big screening work done in the lab for these by identifying the most potent antigens for our infectious disease vaccines.
Just to add one comment here, because you can say it might sound like a lot that we have four different models. Are we spreading our resources too thinly? 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 four different models. 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. 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.
We have a quite scalable approach here where we in a very cost-effective way can improve the performance. 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. While four might sound like a lot, it consists of the same building blocks.
Also, to put these different building blocks in new ways, assembling them for a specific purpose. 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.
Yeah, great. 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 since your come and being the CEO here at Evaxion, with you and your management team, you not only strengthened your balance sheet, but also have generated strong BD relationships.
In our eyes, it looks like the management has been successfully executing that part of the strategy really well. Could you tell us the overall strategy of how you have been approaching BD? 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?
Yeah. 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 with a lot of focus early 2024 and started building structured plans around how to do that. We have had really good progress in that, which we are very pleased with. It is not just the management team, it's actually the whole organization, because we kind of like told everyone early 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 Evaxion target discovery, design, and development.
We need to get that message out. There has been a lot of focus on communicating what we do, how we do it. 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 AI-Immunology, how have we built it up.
That is where it all started, getting the message across in a consistent way. Of course, we are very pleased that we, in September last year, as already mentioned, could enter into a 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 2023, which is a great example of what we want to do with our business development efforts.
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, one plus one should not become two, but it should become three. It is 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.
That is really the focus. 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 2023, 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 2 , but we also have a number of infectious disease pipeline assets that we are bringing forward. 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. There is 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 get. I want to have the right combination of a business development pipeline, which both focuses on pipeline assets, but also around the platform.
I mean, I've been doing a lot of business development in earlier life as well. 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, timing always tends to shift, priorities need to shift.
You need to have a sufficiently broad pipeline. That is what we have been focusing on building up over the past year. It is also fair to say that announcing the Merck agreement in September last year clearly led to an increased inbound interest in discussing what is it AI-Immunology actually can do and has brought us in a quite good position in terms of our business development discussions.
It is focusing on complement to core competencies, but it's also very much focusing on having the right mix of potential partners in place. We will continue that focus because it is about being able to monetize our platform and our pipeline. We are best at doing the target discovery, design, and early development. We are not the ones that are going to do a large-scale pivotal trial for EVX-01 or bring an infectious disease candidate into a large-scale Phase 2 trial ourselves.
That, I believe, I can find many companies who are way better at doing that than we are. On the other hand, I don't think there are many who are better at the early discovery part than we are with our AI-Immunology platform.
I just want to ask one more macro question before we kind of go into the nuts and bolts of what you're doing. As you know, we have had a change of government, change of policies to a large extent, and also with RFK Jr. heading the Health and Human 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 business, but with cancer vaccines and vaccines against certain infectious diseases, how are you? What have you been hearing from your potential suitors? Also, how do you approach your conversations now that the marketplace seems to be changing a little bit?
Yeah. No, let me start off 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. I think that has created a lot of general debate, but also, of course, I agree with you, we are not in traditional vaccines.
On the other hand, there is the perception that a vaccine is a vaccine, and hence it's something that draws interest or attention, I would rather call it than interest. I would say from our discussions with potential partners, it has not changed the discussions.
There are the general view, of course, we know this is a four-year administration, and things will change afterwards. It is not something which changes, I would say, corporate priorities in any way. Of course, you can say it creates a bit of turbulence from a general public communication point of view when you have views being floated, which differ from, yeah, many other views.
We are trying to navigate through it. I would say the good thing about being an early stage clinical company is that we are not affected by all the discussions about customs and tariffs and what you have like some of the more mature companies. At least that's one less thing to worry about. It is definitely clear that it is about navigating through what is noise, what needs to be explained.
It is also about keeping the long-term view, and that is what we are doing, because ultimately, I do believe that science will prevail. With the areas we are in where there are significant unmet needs, I do not worry too much about it. It is, of course, creating short-term turbulence. I am a great believer in having data speak for itself. Ultimately, I believe that will also prevail. I do not 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. As you said, the administration in the U.S., it runs for four years. Yeah.
That's right. Okay, let's get into the fun part of the conversation. Merck has been an excellent partner for you folks since probably your conversation started earlier than 2023, but since 2023, at least we know that they have been an excellent partner for you folks. Recently, they have also increased their equity interest to nearly 20%, as I had said before. 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." 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. I mean, now the Merck Global Health Innovation Fund, they have invested in our last three offerings. In the one public offering we did late January, they actually brought their ownership stake to just below 20%. Of course, we have the R&D collaboration and the optional license agreement with Merck Research Lab.
We actually have the pembrolizumab supply agreement for EVX-01, which dates, yeah, further back. We have a very good relationship with them and are very pleased with that. It is 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.
It is 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. I think it is a broad-based interest, both in the broader capabilities, but it, of course, all starts with our ability to identify the right vaccine targets and validate these. I am super excited about the collaboration, and they are very supportive as a partner as well.
In terms of the collaboration with Merck, you alluded to it a little bit regarding the option exercise that they could be taking. This is on the development of EVX-B3, where you have been collaborating with them. What is EVX-B3 to start off? Also, what's the status of that collaboration not only in 2025? 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?
Yeah, so EVX-B3 is a vaccine against an undisclosed bacterial pathogen. We have not talked about what type of bacterial it is, but it's a pathogen for which no approved vaccine exists. We do see rises in the number of infected people. There is definitely a high medical need for developing novel treatment solutions for this pathogen. Under the collaboration agreement with MSD, we have used AI immunology for identifying relevant targets, so antigens. Currently, we are doing experimental validation of these antigens.
The collaboration is on track. Right now, we are in the last phase of the experimental validation. The expectation is that MSD will make their decision in the second half of this year. We have upfront agreed to the data packets that they will make their decision on. I think we cannot disclose more than that.
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 timeline that we are operating with. Also, as Birgitte Rønø said, what's the data packets that will trigger an exercise of the option?
Very good. 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. That does not matter whether it is only B2 or B3. It is $7.5 million for one and then $10 million for two.
Okay. Let's try to understand what is EVX-B2 then. What is it? Is there a timeline for that too in terms of when you need to deliver a data package, or is it an open-ended timing?
Yeah. EVX-B2 is our vaccine candidate against gonorrhea. We have worked on this for several years. It is a protein-based multi-component vaccine that we have designed with AI-Immunology. We have a pretty strong preclinical data package, and we have demonstrated that EVX-B2 protects mice against gonorrhea. Further, we have shown that 50 different clinically relevant gonorrhea strains are susceptible to EVX-B2-mediated immune killing.
What is under this agreement or collaboration is that MSD is currently doing a few validation experiments, basically confirming our key findings. We have provided protocols and gonorrhea strains and samples from our experiments so they can conduct these analyses. So far, these activities are also on track, and we expect a conclusion in the second half of this year. Basically at the same time of the B3.
You can say timelines for both B2 and B3 are aligned. A conclusion will be reached at the same point in time.
Okay, perfect. Moving on to the rest of the infectious disease portfolio. Just to start off, even though vaccines are being shunned in this country, at the same time, we are seeing a huge, not a huge, but certainly an influx of measles and also bird flu, which is kind of not only impacting humans, but also impacting the economy at a different level. Do you think AI models such as yours that you have can generate vaccines? Actually, is that something that you folks are thinking of? Would that be a viable opportunity at all for you folks?
As we talked about, Eden is our AI model for identifying B cell antigens. Raven is the model we use for identifying T cell epitopes. We strongly believe that if you combine these two 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 two models are broadly applicable, and we have used them to identify targets for both bacterial and viral and parasites.
I do not see any limitations in terms of the pathogens that we can tackle with these two models. With the specific infections or at least outbreaks that you are talking about, there is actually a pretty efficacious measles vaccine. I think the numbers that you are 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. I'm not sure that we would, as an internal focus, develop a novel measles 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 are antibiotic-resistant strains or even further increase in the cases. The discussions we have with potential partners also have a pretty broad range of pathogens that they have an interest in. We don't see any limitations in terms of the applicability of these AI models.
Okay. Among these, within the portfolio of yours, there is another molecule, EVX-B1, which is a preclinical vaccine against Staph aureus, which is, I believe, derived from the Eden model. Large-cap pharmas like Merck, GSK, Pfizer have all attempted to develop preventive vaccines against Staph aureus, but obviously, nothing has been successful and has come through to the market.
How do you think EVX-B1 is differentiating itself against the products that have come through the clinic before? Also, Staph aureus has been an issue not just here, but everywhere. What is the potential for a partner to come in and develop that along with you folks?
Yeah, 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. 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.
Further, the choice of antigens that these companies did was maybe not optimal. We have done a different approach where we have included, as you said, novel Eden-identified antigens, as well as proprietary design, well-described antigens. We have looked at where are the soft spots in this pathogen, so tackling it from multiple angles. We have included in B1 toxoids and virulence factors. 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 animal, so non-rodents, in this surgical site infection model. That, I think, gives us confidence that our B1 vaccine would have a success in clinical trials.
I would say in general, I mean, we are pretty optimistic around partnering potentially. I think, 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. That meant that there was some delay in getting the broader partnering activities going. That's what we are focusing at now.
Okay. Beyond the vaccines that we discussed, B1, B2, and B3, are there plans to expand that portfolio of infectious disease vaccines? If so, would we be hearing of any of them in 2025, or is it going to be 2026 and beyond?
As Christian mentioned, our strategy is, of course, to enter into partnerships. We do anticipate that some of the vaccine candidates that we have developed ourselves, that they will be outlicensed during this year. We need to create a novel or new ID vaccine candidate pipeline. We have a lot of discovery activities ongoing in the company that we can decide on maturing further.
We do have an ambition of starting two new ID projects. One could be, or it could be own programs, or it could also be target discovery collaborations. 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. Moving on to the immuno-oncology part of the pipeline and the company. As we started off this conversation talking about EVX-01 and Pioneer model, what's the unique entity of Pioneer AI model? In targeting neo antigens that specifically have been validated in the clinic has helped to enhance patients' anti-tumor immune response. In your opinion, what are the potentials and challenges of this sort of an approach?
Yeah. 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. We do that based on a tumor biopsy and then on a healthy sample. We can look into the tumor mutational profile and then tailor the vaccine towards those specific mutations. That is a pretty complex process.
We have developed Pioneer that then, in a very automated way, can select the most relevant neoantigens from basically the input is sequencing data from the patient. We know that, of course, other companies are working with this 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. 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. 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 seven weeks from biopsy collection to immunization of the patient. We know that this turnaround time can be further optimized and also scaled, similarly to what has been achieved in the CAR-T field. I think there will be options for further optimizing these processes.
We have done a global shipment, etc. If you can house the manufacturing process under one roof and get the samples to the manufacturing site very fast, then I think we can go way beyond the seven weeks.
Very good. As we talked about the EVX-01, you have generated strong data both during Phase 1 and Phase 2 clinical studies. Could you walk us through that data? What do you think either you or a partner along with you could be doing not only with the data, but also how to progress from here based on the strong data that you have?
Yeah. EVX-01 is our most advanced program. As mentioned, we are currently in Phase 2 . 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. These neo antigens that we identify with AI-Immunology based on these sequencing data.
We concluded on a Phase 1 study in late 2023. 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 neo antigen-specific T cell response in all of the patients in the trial, and there were no side effects related to EVX-01.
In the Phase 1 study, we also saw that the clinical response correlated with the Pioneer score of the neo antigens. This means that our AI system is actually able to identify the neo antigens in the patients that are also linking to clinical response. Based on these promising data, we initiated a Phase 2 study. In September last year at the ESMO Congress, we reported one-year interim data from this trial.
Here, we also had a pretty impressive overall response rate, a little bit higher than in the Phase 1 , of 69% of the patients actually had a response according to the RECIST criteria. Again, we could see that EVX-01 could induce a specific T cell response in all of the patients.
When we looked at all of the neo antigens that we have administered, almost 80% of the selected neo antigens induced a specific T cell response. This underscores the accuracy or precision of Pioneer in selecting the relevant neo antigens. We could see that EVX-01 was well tolerated, confirming the findings of the Phase 1 study. We are looking forward to the next dataset coming out. The two-year readout will be in the second half of 2025.
Very good. It is really encouraging to see Pioneer AI generate a neo antigen vaccine. Also, as you said, eight out of the 10 neo antigens actually gave a functional T cell, which is really exciting because this is against the background where neo antigen vaccines have not really kind of been as successful as they were expected to.
At the same time, do you see that this dataset is actually helping people take a fresh look not only at neo antigens, but also to see how they can take advantage of a Pioneer AI model? Are you folks seeing a more number of incoming calls on this model to initiate a relationship 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. I think everybody agrees that the precision medicines, including personalized cancer vaccines, will become a therapeutic option in the future. I think it's also so clear that personalized cancer vaccines, I mean, as a concept, is something which also brings a little bit of complexity from a supply chain point of view, even though, as Birgitte has mentioned, that can be addressed.
To that extent, I think it's also preferable to have the most possible and the strongest possible data before really engaging in partnering discussions. Hence, you can say that the way I look at it, we need to make sure we have the right package before really engaging, given that it's a novel concept and there are certain issues that need to be put aside.
I would say, of course, there's good interest in the Pioneer and ObsERV for that sake. I think it's also fair to say that while 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. Of course, also, people are eagerly looking at what is Merck and Moderna going to bring out of data when they have the first readout from their Phase 3 .
We are focusing on continuing generating the strong data that we are seeing. Then, of course, have a broad focus on discussing with potential partners along the way while waiting for the two-year data.
Very good. The other model, which is also equally exciting, is the ObsERV within the immuno-oncology space. I know that you've been working on a clinical candidate. How close are you in terms of nominating a clinical candidate and to initiate some preclinical/clinical work on that candidate?
Yeah. We have developed this novel precision cancer concept utilizing this novel class of antigens, as we talked about before, so-called endogenous retroviruses. 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, meaning that you don't need to produce a single batch per patient.
We have used our most recent AI model ObsERV 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. In the second half of 2025, we will share more insights on this very nice concept.
Very good. 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?
Yeah. No, I think it's fair to say that we have a super exciting year ahead, also looking into 2026 for that sake. If we focus on 2025, I mean, from a pipeline point of view, of course, we have the EVX-01 Phase 2 two-year readout, which is going to be super exciting given how EVX-01 have continued to deliver very strong clinical data. Birgitte just talked about the lead candidate selection for our precision vaccine concept.
It's going to be exciting because that's going to open up a new opportunity space for us. We already talked about the two new infectious disease candidates coming into the pipeline this year. From an R&D point of view, several exciting things coming up.
There is, 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 in up to $10 million. We have also communicated in our 2025 milestones that we expect to do at least two new business development agreements for the year. I think we will be, or we are already busy, but hopefully, we will also be busy announcing some key milestones here. A lot of exciting things are coming up over the time ahead.
Very good. As I started off this conversation, now that you really do not have a financial overhang, so to speak, at least for the next 18 months or so, what does that allow you to do both in the clinic, in the preclinic? How should we, as investors, think about growth without that financial overhang on you? Also, just for closing, what should investors expect from Evaxion?
Yeah. No, I think, first of all, I mean, it has been really nice removing that financing overhang that we have had. I mean, in our latest filing from January, we had around $12 million in cash. We brought in another $11 million. Now we have cash into mid 2026. If, say, Merck exercises the option, we get $10 million, then we have cash into 2027. What this allows us to do is, of course, have full focus on executing on near-term plans, but also discussing what are the value creation opportunities that we see for the longer term. We already kicked off some weeks ago after completing the financing. I am in the process of designing that and hopefully will be able to communicate something later on in the year.
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. It is a lot of opportunities. I also believe in having the right focus and growing from the core. That is what we are focusing very much on doing now.
Clear, with 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.
That's been truly exciting to transition into that next phase where we have the foundation in place. We have the pipeline of business development opportunities. We are in the lucky situation that we have an R&D pipeline, which is super exciting and have delivered strong data so far. We are excited about what to bring from the pipeline in the time ahead. I think we are in a good spot. It's exciting to be able to, yeah, look a bit further ahead and also how we want to create value not only tomorrow, but in years from now.
Thank you. Thank you, Christian and Birgitte, for participating in our H.C. Wainwright at Home Series. Looking forward to talking to you soon. Thank you and good luck.
Thanks for having us.