Good day, and thank you for standing by. Welcome to the Evaxion Out-Licenses Vaccine Candidate EVX-B3 to MSD webcast and conference call. At this time, all participants are in the listen-only mode. After the speaker's presentation, there'll be a question-and-answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Interim CEO and CSO, Birgitte Rønø. Please go ahead.
Thank you. G ood morning and good afternoon, and thank you all for joining us, and a warm welcome to this exciting conference call. I'm Birgitte Rønø, CSO and Interim CEO of Evaxion, and I'm joined today by Thomas Schmidt, our CFO, and Ms. Kronborg, VP of Investor Relations and Communication. E arlier today, we shared an important update. MSD, or Merck, has exercised its option to license our EVX-B3 program, and this marks a significant milestone not just for Evaxion, but for the broader field of AI-driven drug development. It is the first time a pharmaceutical company has in-licensed a vaccine candidate discovered using AI, and we are extremely proud to be leading this change.
Today's call will, of course, focus on this major milestone, and alongside, MSD holds an option on a vaccine candidate, EVX-B2, for which the evaluation period is extended with a decision period on potential in-licensing now expected in the first half of 2026. Let's begin by walking through the agenda for today's presentation. I'll begin with the highlights of the MSD deal, and then I'll walk you through our proprietary AI-Immunology platform and how it enables novel vaccine target discovery. Then Thomas will present our financial and cash position, and I will return with some conclusive remarks before we open the floor for a Q&A session. Before we dive into the detail, I would like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risk and uncertainties, and actual results may differ materially.
This is a historic moment not just for Evaxion, but also because it marks the first-ever in-licensing of an AI-discovered vaccine candidate by a major pharmaceutical company. The exercise fee of $7.5 million extends our runway into the first half of 2027. The deal confirms our strategy of value creation through partnerships, even with industry giants like MSD. It also validates our AI-I mmunology platform and our R&D pipeline, and further, it ensures future development of the EVX-B3 candidate without cost for Evaxion. N ot related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. L et's take a closer look on how this partnership with MSD has evolved over time. In 2023, we began a target discovery collaboration on EVX-B3, addressing a bacterial pathogen with high unmet medical needs where no vaccine is available.
One year later, in 2024, the collaboration expanded to include EVX-B2 with an upfront payment of $3.2 million and potential milestones up to $592 million per product, and now, in 2025, MSD has exercised its option on EVX-B3 while extending the evaluation period for EVX-B2, demonstrating commitment to both programs. It fits into our broader pipeline and strategic milestones for this year. As you can see, 2025 is shaping up to be a pivotal year for Evaxion. We have already achieved several key milestones, and more are on the horizon. We've completed EVX-01 dosing and released supplemental Phase 2 data. We've added a new infectious disease vaccine pipeline candidate, and we've now seen that MSD has exercised the option, which brings in $7.5 million.
Looking ahead, we expect further progress of our cancer vaccine candidates, the CMV program, and also progress within improving our AI-Immunology platform. Further, we also anticipate an additional new business development agreement. N ow let's shift focus to the technology that powers these breakthroughs. AI-Immunology is the heart of our innovation. It's our proprietary platform that has been validated in three clinical trials. It is fast. We can do target discovery within just 24 hours. It is scalable, and we can apply AI-Immunology to over 100 different diseases. We have also seen that we can reduce the testing by 80%, and the platform is also delivery platform agnostic. It works across protein, DNA, messenger RNA, and peptide modalities. It is extremely accurate.
We have seen in our EVX-01 Phase 2 trial that we have a 80% hit rate of the vaccine target that we have administered to the patients. It is also cost-effective. We can see that it is 90% cheaper than reverse vaccinology, which is the standard way that a pharma is identifying novel vaccine targets. So let me describe how our AI-Immunology works in more detail. We feed in genomic, transcriptomic, or proteomic data, and then our AI model identifies the most promising antigens for vaccine development. It then spits out a range shortlist that we can start working on, and it accelerates vaccine validation and design. We have used AI-Immunology in our EVX-B3 program. EVX-B3 is a prime example of our platform's potential. It targets a bacterial pathogen with no approved vaccine despite decades of research. Previous efforts have yielded little progress.
EVX-B3 could be a breakthrough addressing recurrent infections and severe complications caused by this pathogen. Now MSD has decided to in-license this program, which underscores the potential of the EVX-B3 vaccine candidate as such, and also the ability of our AI platform to identify therapeutically relevant vaccine targets. Now let's turn to the second program under evaluation, EVX-B2. MSD's decision to extend and expand this evaluation period for EVX-B2 reflects their continued interest and commitment to this program. With further testing underway, a licensing decision is expected in the first half of 2026. If MSD decides to exercise, Evaxion , we'll receive $2.5 million in option fee and up to $592 million in milestones, as well as royalties on sales. Let's take a closer look at what makes EVX-B2 so promising. EVX-B2 addresses a critical unmet medical need: gonorrhea.
With rising antibiotic resistance and no existing prophylactic vaccine, our multi-component approach offers a compelling solution. The preclinical data is strong, and the global impact could be significant, as more than 80 million new infections were reported globally in 2020. Yeah, sorry. Now I will hand over to Thomas, who will walk us through how this deal impacts our cash position.
Yes, thank you, Birgitte. A s Birgitte said, truly a remarkable day for us as Evaxion, as we've now out-license the B3 program. T he program in itself and the deal that we have made with MSD is obviously that here and now we receive $7.5 million on the in-licensing of the B3 program, which obviously also means that all future costs in development now will be dealt with from MSD perspective. W e will have no cost further involved in that. But we will have potential milestones to support our future cash generation, as hopefully the program progresses through development phase, regulatory approvals, and sales, with a total of up to $592 million, as well as royalties included in the deal. So truly a remarkable change also in terms of how we can generate future cash.
If we do look at our cash position and what this also means for our cash position, first and foremost, let me also just mention the initiatives that we have done throughout 2025 so far with the focus to strengthen our financial position. Earlier in the year, in January, we have done capital market activities and public offering, totaling close to $17 million. In July, we also announced that we did an agreement with the European Investment Bank to convert debt into equity worth $4.1 million. The $4.1 million, I should, of course, mention, is not cash income, but will improve not only our balance sheet, but also the upcoming and forthcoming interest rates to be paid, t herefore, also improving our cash flow as we move forward.
Now, as of today, here in September, and as announced today, we then will receive $7.5 million income from the in-license of the MSD or out-licensed, sorry, of the MSD B3 program. That will bring our cash runway into the first half year of 2027. So really also gives us a nice cash position and a nice cash runway to fund the continued operations of our company. I think as a biotech TechBio company, that is really, really a good position that we have moved ourselves into with these initiatives. W ith that, I hand it back to Birgitte.
Thank you, Thomas. So as we conclude today's presentation, I would like to highlight the significance of this deal. T he deal represents a strong validation from a global leader in vaccine development, reinforcing the credibility of our AI platform and the strength of our R&D pipeline. It also confirms our strategy as it underlines our ability to out-licensed and monetize assets through high-value partnerships. M oreover, it underscores the uniqueness and value of our proprietary AI-Immunology platform, which continues to deliver differentiated vaccine candidates. F inally, as Thomas just alluded to, the agreement strengthens our financial position, extending our cash runway into the first half of 2027 and provides a solid foundation for continued execution. T hank you for your attention, and we are now happy to take your questions.
Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. We will now go to your first question. One moment, please. Y our first question today comes from the line of Thomas Flaten from Lake Street. Please go ahead.
Yeah, hey guys, I appreciate you taking the questions. First question for Thomas. Will this be recorded as revenue, or will it be just a pure balance sheet transaction when we look to update our model?
Yeah, hi Thomas, thanks. Yes, so the $7.5 million that we will now receive from Merck will be recorded as revenue.
Excellent. And Birgitte, can you maybe give us some more detail on the nature of the extension of the evaluation period into the first half? Was it just work they didn't complete? Was there incremental interest in doing some different work? I'm just trying to understand. That's a pretty significant delay, and I'm just trying to understand what caused that.
Of course. W e have been working with the MSD Research Lab on the B2 for almost a year now, and they have done several experiments confirming our bindings. We know that they're interested in strengthening the data package. W ith this extension, and I would also call it expansion, they're conducting several new experiments.
Okay. So just to clarify, it's an extension and an expansion?
Yes.
Excellent. I appreciate you taking the question. Thank you.
Thank you. Your next question today comes from the line of Kevin DeGeeter from Ladenburg Thalmann. Please go ahead.
Hey, thanks for taking my questions. Really exciting announcement. I guess just sort of stepping back, one of the promises of AI, or sort of target discovery, is the ability to kind of scale and scale rapidly. How many potential targets could you sort of look at with other pharmas, perhaps from a business development perspective, with the available resources and kind of just stepping back, kind of any learnings from this experience from Merck? I mean, this is a bit of a unique opportunity to take a target of interest by Merck and just really sort of run it all the way through to license. Yeah, I'm just trying to understand if you can do more business development, how quickly can this model kind of scale?
Yeah, thank you for that question. I t definitely depends on how far we take these programs. O ur AI-Immunology platform would be able to identify promising targets within 24 hours. T hen, of course, after AI-Immunology ranking the top candidates, we would do some design experiments, and we'd also manufacture these candidates for preclinical testing. I n terms of limitations or indications, we don't really see any limitations. AI-Immunology is also scalable. We expect that we can use the platform in other disease areas where there is a strong immunological component. I don't see that there are any limitations in terms of how many deals can you make within this space as it is scalable to other therapeutic areas.
One key example, autoimmune diseases, where I think there's in the past been a focus on several targets, and not a lot of new ideas are coming out in this space. We would definitely be able to use AI-Immunology and target these diseases in a different way than what has been done in the past.
Very exciting. J ust as sort of my follow-up, you mentioned business development in your prepared comments. Getting this license agreement done, I think is likely to help in any future business development discussions. Is your priority more with regard to potentially outlicensing the Evaxion developed programs, many of which you've already disclosed to the investment community, or is it more focused from a business development resource perspective on opportunities like this one with Merck, where the pharma brings you a candidate that the investment community hasn't learned about previously and may not know that much about initially?
Yeah, really great question. T he answer is we will do both. We definitely welcome any requests on target discovery collaboration, s imilar to what we have done with MSD. But we will also continue with our own R&D pipeline, t aking programs to preclinical development and also select candidates into early clinical development. I t will be the focus is on both of these two tracks.
Thank you for taking my questions.
Thank you. We will now go to the next question. T he next question comes from the line of Swayampakula Ramakanth from H.C. Wainwright. Please go ahead.
Thank you. Good afternoon, Birgitte. Congratulations. With the added $7.5 million to your balance sheet, where do you see the immediate need for funds? Is that going to be utilized more in pipeline/new molecule development, or is it going to be earmarked more for expanding your AI models and trying to bring another new AI-I mmunology platform?
Yeah, thank you for that question. W e will definitely invest in improving our AI-Immunology platform in the future. This is not a very costly exercise. We use, yeah, public data for improving AI-Immunology and then building new tools. T his is more a resource-demanding exercise. We will, of course, also invest in our R&D pipeline in the future, and since we have our own lab and animal facility, we can actually move fast and also pretty cost-effective from AI target discovery into preclinical development. O f course, it becomes more costly if you take programs into the clinic. Ambition of it actually is to continue to do early preclinical studies and late preclinical studies, and also taking them into the clinic.
Fantastic. Thanks. Regarding EVX-B2, the decision that Merck is yet to make, I know you gave some color regarding how they want to progress from here. But in your own discussions, based on all the data discussions that you did on B3, what do you surmise Merck is thinking regarding the B2 program? H ow definite are you that they would follow through and pick up that option as well, I mean, exercise that option as well before the end of first half 2026?
Yeah. So as I mentioned, MSD will do more testing of EVX-B2, so expanding the evaluation program. I think I will not speculate on when they will decide, and I will not speculate on what exactly they would like to see. But there's no doubt that they have continued interest in this program.
Very good. C oming to EVX-01, it's exciting that within a month from here, we're going to see the two-year data point. Merck also has interest in melanoma with Keytruda potentially losing its patents in 2028. D o you see a path forward with Merck on that or any other currently anti-PD-1 therapies which are out there for melanoma?
Yeah, so it's very exciting that we will be presenting two-year data from our EVX-01 Phase 2 study at ESMO on October 17. As we've mentioned earlier on, we are looking for a partner for this, our main asset, and Merck could definitely be a good fit. But it could also be another pharma company with an interest in personalized cancer vaccines. I don't see that we are limited or that it can only be MSD. It can definitely be another pharma company.
The last question for me. O n the docket, you still have two clinical candidates to announce. One is an ERV, and the other is an infectious disease. So when you plan to announce the lead candidates for these two programs, would you also be presenting any preclinical data around them, or would it just be the candidates?
No, we will definitely be presenting preclinical data on this vaccine candidate later this year. Yes. We are extremely excited about the ERV-based cancer vaccines and their potential within this shared vaccine field.
Perfect. Thank you very much. Thanks for taking all my questions, Birgitte. Congratulations again.
Thank you.
Thank you. As a reminder, if you would like to ask a question, please press star one and one on your telephone keypad. We will now go to the next question, and your next question today comes from the line of Soumit Roy from JonesTrading. Please go ahead.
Good morning, everyone. Congratulations again on the outlicensing deal. A quick one. Broadly looking at the business development perspective, the ROI seems to be better in the infectious disease area. Is this where we can see the company completely converting over the years, or oncology still remains a major focus?
I'm not entirely sure what you mean. Could you perhaps repeat? Y our question was around whether we would solely focus on one therapy area?
Yeah. If you would focus more into the infectious disease area because the ROI and turnaround seems to be much more effective there. Going to flu vaccines, which are highly mutable year to year, and there is a demand for an effective flu vaccine every year. Do you see the company more effective in the infectious disease area than oncology?
Yeah. T hank you for that question. W e do have the ambition of staying in oncology and also continue in infectious diseases and further to expand into other therapeutic areas. We do see a clear fit for AI-Immunology, so our core platform, in several diseases where there is a strong immunological component. W e will definitely try to scale into additional therapy areas as well.
Got it. On the oncology side, EVX-01, we have the two-year data coming. I understand these patients will continue with the two to three booster dosing after two years and follow up. Will there be any further development into Phase 2, or will we wait for partnership, and then meanwhile you move into EVX-03 or any other targets?
Yeah. W e are definitely looking for a partner for EVX-01. We will, as you mentioned, we now have a subset of patients in this expansion phase of the trial. T hey will receive EVX-01 as monotherapy, and we will, of course, monitor their clinical status, but also T-cell responses in these patients. But yes, we are looking for a partner that can continue the development of this very exciting asset.
Great. You probably addressed it in the previous question. Did you give us a timeline on when the next candidate in oncology will be announced, or do you have an idea?
We have a milestone coming up in this fall, and that is lead candidate nomination of our ERV-based cancer vaccine. But we have not yet disclosed anything around the next or the timing of our next candidate that will enter into the clinic.
Got it. Thank you. C ongratulations again on the deal today.
Thank you.
Thank you.
Thank you. Once again, if you would like to ask a question, please press star one and one on your telephone keypad. That is star one and one if you would like to ask a question. There are currently no further questions. I will hand the call back to Birgitte Rønø for closing remarks.
Yes. Thank you. And thank you for participating. I f you have any further questions, please do not hesitate to reach out to us. Thank you.
Thank you. That concludes today's conference call. Thank you for participating. You may now disconnect.