Welcome, everyone, to this session of our 2025 year-end conference. I'm Alex Hantman, and I serve as an equity research analyst here at Sidoti & Company. Today, we're pleased to be in conversation with CFO Thomas Schmidt of Evaxion Biotech, ticker EVAX. During the presentation, please feel welcome to submit questions using the Zoom Q&A interface at the bottom of your screen. After the presentation, we'll open to your questions. And with that, Thomas, I'll turn it over to you.
Thank you, Alex. And a warm welcome from my side. Good morning to everyone on the call, on the line. And I'm happy to now present our Evaxion case and investment case to all on the line. Evaxion is a company that was founded now 17 years ago as a true and first AI company with the focus of really decoding the human immune system, and with that, to develop new and novel cancer vaccines and vaccines within the infectious disease area based upon the AI-Immunology platform. So long before AI became a hot area. So really looking forward to going through this presentation. A lot of the things in here are indeed forward-looking, so we all know about the uncertainty around that. So just wanted to make sure that that was also covered. We are a pioneer in fast and effective AI-powered development.
AI-Immunology is really the focus of our business, AI-Immunology, as we have labeled it also. It's a clinically validated platform. You will not see many other AI platforms in the market that have been clinically validated, but ours is, and we basically develop or use that platform to do target discovery together with partners. One example of that is Merck, the U.S. company Merck, came to us with a disease area where they had not had success in discovering new vaccine targets, so with us using our platform, we came up with what was the so-called EVX-B3 program that we later on then have outlicensed to Merck, which we did in September this year. I'll come a little bit back to that deal later, but just as an example of how we can use that platform.
At the same time, we do development of our own pipeline programs where we can see that there is a huge unmet need and where we can see that there is value in driving those programs forward. And later on, of course, we would want to outlicense those programs also. As a strategy, we want to outlicense our program no later than in phase II. Some before, but latest by phase II, so not taking programs into phase III. We have a multi-partner approach. I mentioned already, we've done a deal in September with Merck, but we are certainly also looking with other pharma companies, biotech companies, to do partnership deals. Merck is also a key supporter and collaborator of ours, and Merck has actually also become our last investor in the company with a 15% shareholding at current.
So that we are, of course, extremely happy about and certainly also a good, strong collaboration with the company. The platform AI-Immunology, as mentioned already, is validated, and we've done that with three different clinical trials. What it also is, it is incredibly fast. Actually, within 24 hours, we can complete a target discovery. I've worked within the healthcare and pharma industry for 27 years, many of those years with the pharma company Roche, and I can tell you, 24 hours is certainly a dream in the pharma industry, where normal target discovery takes up to years, if at all they finally discover the real target. What it also does, our platform, is a ranked list of targets that needs to be tested and also with a likelihood of success.
So that also means that we need to test significantly fewer targets, up to 80% fewer targets, which obviously means much more cost-effective if we compare that against reverse vaccinology. It's also incredibly accurate. 81% of the vaccines target has a hit rate, and that has also, again, been confirmed very recently when we had the two-year data readout for our lead candidate within melanoma. The platform is also agnostic. We have different modalities, four different modalities: protein, DNA, mRNA, and also peptides, and is possible to be scaled into a number of different disease areas.
Of course, as we are talking about immunology and the immune system, just as an example, one good scalable area could be autoimmune diseases, just to name one, but many possible scalabilities left, which again just underlines and shows huge potential in terms of our platform and what we can do with target discovery, design, and development. We focus, as mentioned already, on immunology, so cancer vaccines and also vaccines within infectious diseases. Everyone, I'm pretty sure of, knows the huge global market size of the cancer immunology area, but also the infectious disease vaccines area is expected to be close to $68 billion by 2031. So also a very attractive market to be in, and that comes, of course, also with growing antibiotic resistance, the general healthcare burden that we see throughout the world with an aging population, so is only expected to further grow beyond that mark also.
There's also a number of vaccines out there or areas or diseases where there are no approved vaccines at current, and that's, of course, where we have developed in our pipeline system, here mentioned with three: Staph aureus, gonorrhea, and also CMV virus in our program, so really, really good and strong potential also there. The leadership, I myself, is on the list here also, of course, but we also have a very strong leadership with very good experience across all areas. Helen Tayton-Martin joined us as new CEO as of November 24 this year. Helen has joined us as a board member earlier this year, but has now taken the role of CEO November 24. She comes with a breadth of experience, latest also with Adaptimmune, but has also worked for Trillium in the past.
Birgitte, our Chief Scientific Officer, has been with the company for the past eight years, but also has a background within Novo, similar to Founder Andreas, who's our Chief AI Officer. So really good, strong experience. What have we achieved over the past quarter and months? If I look towards business development, I mentioned that a bit already in the beginning. We did a historic outlicensing deal with Merck, where Merck basically in-licensed our EVX-B3 program. That was a massive validation of our platform and our business. We're extremely happy about that also. And also, of course, it provided immediate cash with a down payment of $7.5 million, and furthermore, also has the potential of up to $592 million in milestone payments, as Merck now will take that program on and develop it further from preclinical into clinical and eventually to the market.
Milestone payments as well as royalties up to the tune of $592 million. We have also an agreement with Merck on one of our other programs, EVX-B2. This is a vaccine within gonorrhea, and that evaluation period has been extended, and we expect a final outcome of that in the first half of 2026. At the same time, over the past course, also several of our ongoing discussions. Of course, the aim is, as mentioned earlier, to get a multi-partner approach, and therefore others, big pharma companies also engage with the partnerships. On the R&D side, our lead candidate, EVX-01, we had a two-year phase II data readout presented at the European Society for Medical Oncology, which was hosted in Berlin in early October with really unprecedented data.
I will come back to that data in a later slide also, but very, very proud of that achievement also that we did there. Also, we've recently also announced that we will progress with EVX-04, which is a novel precision cancer vaccine, also built around the so-called dark genome. So also really, really interesting from a pipeline perspective. And the EVX-04 and the dark genome certainly has sparked interest within the medical field also. So a lot of good discussions around that also. Our AI-Immunology, as mentioned already, is really the core of our development, and we continue, of course, to invest into that. So from target discovery to design, we've now also implemented an automated vaccine design module that, apart from improved quality, certainly also reduces time that was earlier a very manual process.
Strengthening, once again, our platform in making it fast, efficient, and with high quality. On the cash runway side of things, with the activities we've also done, we've now extended the cash runway until the second half of 2027. That I am, of course, also particularly proud of since we now have quite some road ahead of us where we have cash available. We'll continue to, of course, look for ways and means to extend that, which could either be based on new deals coming in or other measures that we will take. But the key focus is, of course, to drive that forward. Just stepping one step back, I mentioned this already, first-ever in-licensing of an AI-discovered vaccine candidate now outlicensed to a pharmaceutical company, our EVX-B3. So really a transformational deal for us at Evaxion.
I mentioned already the financial side of it with the exercise fee and also the longer-term potential with that, and really has confirmed that the value creation of our strategy has really, really been given a big, big boost and validation. So extremely happy about that also. And now, as mentioned already, Merck will take that future development of EVX-B3 onto their books, which will not have any further costs on that program from an Evaxion side. So our, of course, option or optional possibility is, of course, now getting milestone payments in as the program progresses. And last but not least, also with that collaboration, as mentioned already, the EVX-B2, the extended evaluation period with additional testing, we now expect to receive final decision on that in the first half of 2026.
We've also progressed very well on the milestones that we've set ourselves for 2025 and certainly also on the value catalyst that we have identified. We really have executed, I would say, extremely well to that on that tune so only two boxes left yet unticked, but really, really a strong underlining of how we execute and deliver on the targets that we set. We're now, of course, closing the year out and will soon also be looking towards setting new ambitious milestones and value catalysts also for 2026 so that I will definitely come back with at a later given point of time. Looking towards our pipeline, we have a pipeline, as mentioned, in the cancer, but also in the infectious diseases. EVX-01, advanced melanoma, so really a personalized cancer vaccine. I will come back to that in a few seconds also.
EVX-04, which is an AML, so acute leukemia, all in the early preclinical, or not all, but in the preclinical stage, so we are looking already, of course, for potential partners in that field also, but do want to take that program forward also, so that we will certainly also do. On the infectious side, we have B1, which is Staph aureus now towards the end of the preclinical phase, gonorrhea, as mentioned already, towards MSD, and EVX-B4, Group A Streptococcus, which is a target discovery and will move into the preclinical phase also, and then last but not least, our CMV is also in a preclinical phase, and all of these, we are, of course, actively looking to see the interest within the market and with partners, so really a good, strong pipeline for a company of our size.
I think that just underlines the capability of our AI-Immunology platform in finding new targets that have not been found before. So really unique in that setting. If I turn back to EVX-01, we had the two-year data readout in October presented at ESMO. EVX-01 is a first-line treatment for advanced melanoma. So advanced meaning melanoma patients in stage three and four. We basically, in the trial, have combined our EVX-01 with anti-PD-L1 antibody, in this case, Merck's Keytruda. It's our program, so I should just also underline, Merck does not have any option. They have supplied us with a supply agreement on Keytruda, but it is our program and can and will be or can be licensed out to any other given pharma company. Most importantly, on the key data was that we in the phase II, two-year data showed an overall response rate of 75%.
Quite unheard of, and certainly also if you compare that against Keytruda in their registration trial, they showed at the same time a 33% overall response rate. So really, really strong. And again, also here mentioned in the beginning, 81% of the vaccine targets induced a specific immune response. So really, really strong data coming out of that. If we look at the 16 patients in the trial, I think also what I would want to highlight here is that four out of the 16, so in other words, 25% of the patients achieved complete remission of tumor lesions. So really a good, strong result in that. And at the same time also, 92% of the responders demonstrated still a response after two years. So after 24 months, obviously, still demonstrating response is also quite impressive. So really, really good data coming out.
And with that, we've, of course, used that to also after the ESMO conference to discuss partner opportunities. EVX-04, I mentioned that also is planned to be an off-the-shelf therapeutic cancer vaccine for AML. It's again also designed on our AI-Immunology platform, and it targets tumor-specific antigens derived from ERVs. So it's planned to be investigated first in human study in AML patients and in combination with also these two products that we mentioned here. Quite a unique setting also, and has created this ERF and dark genome has created quite a lot of interest and discussions also in the market. So really, really looking forward to move this program forward. High unmet need also in this area. So really another value driver for us in the future. Quickly, just as I also look to the time, just explaining quickly the EVX-B2, a gonorrhea vaccine, prophylactic vaccine.
For years, the pharma industry has really tried to find a vaccine in this area, but there exists none today, and our data really shows that it demonstrates strong efficacy against 50 clinically relevant strains of gonorrhea, and it induces a strong humoral and cellular immune response. So really also a high and important program of ours within the infectious diseases, so there's 82 million new infections caused by gonorrhea globally back in 2020, and that number certainly has not gone down, so also here, quite a high unmet need. What I also wanted to mention is, again, back to our cash runway that we have extended now to the second half of 2027. We've done and executed extremely well along our financial strategy throughout 2025. Among other, we've, of course, done a public offering back in January.
We've sold the MSD exercise, or we've gotten the MSD exercise fee on the EVX-B3, and we've done an ATM and also seen a lot of investor warrants income or cash income in the latter part of this year. At the same time, also, we've agreed with the European Investment Bank to convert roughly half of the loan that we had with them into equity, and we did that actually at a price premium when we did it at 90% on the day that we published that agreement, so also there, the EIB, which don't normally agree to convert debt into equity, also were willing to pay or trade at a premium due to the potential that they also did see and do see within Evaxion.
So, really, really happy about this strong financial execution and certainly also improves both our cash runway and also improves and simplifies our balance sheet and our leverage. So, really, really nice. So, why should you invest in Evaxion? Truly AI-first company that have built a pioneering clinically validated platform of vaccine discovery, design, and development. We have a strong pipeline, I would say, around both clinical but also preclinical vaccine candidates, both in cancer and also in infectious disease. And I think we are executing extremely well along the strategy that we have. And with that, we hope to monetize even more value through our business development. As mentioned already, Merck has a 15% ownership of the company, but we want to stay independent and we want to grow the value within the company.
Thank you, and I will now hand it back to you, Alex, and ready to take any given questions there might be.
Great. Well, thank you very much, Thomas, for sharing this with us. We have a couple of questions from the audience around milestone payments. So I think folks were excited to hear the size of the Merck partnership. Could you talk a little bit more about which milestones lead to what size payments and over time how that might come in?
Yeah, Alex, I can't share the details of the agreement, but I can say it's a fairly classical milestone payment agreement that we have made with Merck that is also seen in the pharma industry, so of course, as they take the development through the development phase and clinical stages, we will, at those steps, receive payments, but further details, I won't be able to share.
Understood. Thank you for sharing what you could, and we have another question around you showed a number of great assets in development, some of which more advanced than others. Could you talk about how the company is prioritizing resources in 2026 and more about allocating resources and any specific guidance?
Yeah, good question. So, of course, for us, business development deals in terms of partnerships on these programs are all in the key focus of ours. From a pure development perspective, we've also taken a decision that on the infectious disease side of pipelines, we want to develop those up to the stage of taking them into the clinic. So quite normal, we will see partnerships form there at an earlier stage than maybe what we see on the pipelines within oncology or cancer. So that means, of course, also spend, if you will, are probably a bit higher on the oncology side, but it doesn't mean that we are not focusing on the infectious disease side also. So resources are split quite nicely between those two areas. And at the same time, we invest into our platform in itself.
Thank you for sharing. And I know you've spoken about Merck's interest in the company and the extent of your partnership. Is there an opportunity for Merck to even further expand the partnership either across other assets, maybe particularly EVX-01?
Yes, in the sense of we're open to collaborations, as I said, with a number of different partners. So we don't have a first right of refusal or anything from a Merck perspective. So regarding EVX-01, I should maybe say Merck is also doing development together with Moderna. But yes, theoretically, everything is possible. We don't rule one or the other out. But it could also very easily and well be used and taken by other pharma companies.
Makes sense. Let's maybe take one or two more questions, but we have still on EVX-01, someone is asking, what kind of production time currently exists from the taking of a patient sample to delivery of a finished product for infusion?
That is roughly, if I remember correctly, it's a good question. I think seven days.
That's great. And maybe as the last question, I'll just point out, right, the stock is up 110% in the last six months. I think you just shared a slide with some great upcoming catalysts. What do you think has most resonated with the street and for investors who maybe like what you're doing with AI, like the results you're getting, but they're not sure if now is the right timing to get in or to have a conversation, what would you say to them?
So yes, our stock has traded nicely up over the past many months. And certainly, some of our value catalysts that we've delivered upon has helped in driving that up. So amongst other things, clearly, the Merck outlicensing, but also the two-year data. And I think it becomes also within the industry, we are getting a lot of further attention because of the unique platform that we have. Maybe I should also mention that we've actually also collaborated with the Gates Foundation, where the Gates Foundation also has come to us to ask for a target discovery of a portfolio vaccine. And it just shows you, rather than anything else, that we are being spotted even by big organizations like the Gates Foundation also. That does for sure an element of horizon scanning and who would be the best fit for helping them in their doings and dealings.
And I think that just underlines the strength of Evaxion and what we are capable of. So I think as an investor, I would only recommend to have a close look at our business and certainly also, yeah, take value on that further journey that we aim to create.
Great. Well, with that, we are at time. So I'd like to thank you, Thomas, for sharing the Evaxion story with us and also thank everybody listening for spending time with us today.
Thank you, Alex, and thank you to everyone also for my side.