Evaxion A/S

Good day, and thank you for standing by. Welcome to the Evaxion business update and first quarter 2026 financial results webcast and conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, CEO Helen Taiton-Martin. Please go ahead.

Thank you. And welcome, everyone, to Evaction's Q1 2026 business update call. I'm very pleased to be joined today by our CSO, Regina Rono, our COO, recently promoted. We'll talk more about that. And Thomas Schmidt, our CFO, and our Head of Investor Relations and Communications, Mads Kronberg. So we move to the first slide just to provide some orientation as to what we will cover today. We will spend a little bit of time on our achievements in the first quarter of this year and some notable changes that we have made in order to address and focus on our strategy. I will then hand over to Birgitta, who will talk through some of the recent highlights from our R&D portfolio on AI Immunology Platform. Magida will then hand over to Thomas, who will walk you through our Q1 financial results. And then we will have some concluding remarks before opening up the call for Q&A. So if I move to the next slide, just to reiterate, we may make some forward-looking statements on the call today. And investors and all listening are guided towards our SEC files documents. So if I go past our introduction to slide five. I just wanted to, as before, emphasize our four key focus areas within the organization and give you a sense of the momentum as we perform an update in each of those areas. First of all, our core focus around business development and partnering is very much underway and strengthened by the way we have reorganized the organization I'll come on to that to focus on the external outreach and positioning of the company to a broader audience and also to raise the awareness of exactly what it is that Evaction can deliver in terms of products and the platform. And I'm pleased to say that we have many discussions ongoing there and we hope to report more on that later as the year progresses. In our R&D focus areas, we're delighted to talk about our recent data from our EVX01 Leave Program Phase 2 study, in which we were able to update some of the translational data recently at AACR. And Birgitta will talk in more detail about the performance of the cells that we produce in relation to the vaccines given to the patients and the 86% immunogenicity conversion rate we have there. We also were able to present at AACR a new set of data preclinically in collaboration with our collaborators at Duke University on the scope to use the AI platform in glioblastoma. We have always felt that the approach could be applied to other high-mutational burden tumors, but also to others where high-mutational burden was not a feature, and that is very much part of how we were able to demonstrate the broader applicability of the platform in glioblastoma, and again, Birgitta will speak more to that. And finally, we were able to confirm the completion of the last patient, last visit in the extension phase of our EVX01 program and our Phase II trial, and more to come on that later in the year. More broadly on the AI Immunology platform, we continued to optimize and strengthen that around its ability to deliver products across our infectious diseases, as well as oncology portfolio, and again, also autoimmune disease, again, where we'll update later in the year. But in this first quarter, I'm delighted to say that we were able to show some initial data on a new polio vaccine concept presented in collaboration with the Gates Foundation. And finally, as Thomas will come on to, we have maintained our disciplined allocation of resources aligned to our stated aims with the portfolio and the platform, and our cash runway remains unchanged into the second half of 2027. Moving to slide six, as mentioned, we have reorganised slightly inside the organisation. I'm delighted to announce the promotion of Begida to the combined role of CSO and COO. which really reflects on how we organise the company and how well it's been run in recent times, but also to enable me in particular to have a greater focus externally on behalf of the company in terms of our business development and our investor interaction. Separately and in parallel, we were able to welcome Jens Bishnorheve to our board of directors, and Jens comes to us with a huge amount of experience in BD and corporate strategy and outreach in general, both from age. biotech perspective, but more recently from J&J and Henry, where he is currently corporate VP and global head of corporate development. So we're delighted with the way that we've been able to strengthen the organization to focus on our stated strategy to build and maintain what we have and build greater partnerships. So on slide seven, just to summarize, we remain a lean and capable and focused team in terms of the management organization. Two of the members are here on the call with me today, and Andrea continues to support and drive the organization's innovation strategy around AI immunology. And our board remains the same, but with the addition of Jens, as I mentioned. Finally, moving to slide eight to set up our objectives and key milestones for this year. Just a reminder that VACTION, over many years, now has the privilege of having a pipeline in phase two in oncology with our EVXO1 asset in advanced melanoma, our personalized neoantigen-directed peptide-based vaccine, where we've got great data, which Benita will touch on in terms of now and what's to come. We have our EVXO3 program, which is a combination of personalized and ERV-based antigens on our DNA platform. And then we also have coming along in preclinical development, aiming for clinical readiness by the end of this year, off-the-shelf vaccine program, EVXO4, targeted to AML, which will be a single vaccine approach for multiple AML patients. More to come on that. Infectious diseases, we remain focused on driving forward our preclinical assets, EVXB1 against pathogens, Staph aureus. Our B2 program against Ethereogonorrhea and also in collaboration with Afrogen on an RNA platform. EVXB3, our optioned partner program, continues to move forward with MSD. And B4, our more recent, newer program on Group A Streptococcus, is making great strides in initial early discovery component design. And our first viral program is continuing to make progress in terms of confirming the candidate components. So a lot going on in the organization. In slide nine, I just wanted to remind the audience of our 2026 milestones and the fact that we have achieved the first one of those in our EVX01 additional biomarker and immunogenicity data, and we remain on track in terms of updating on the approach of AI immunology in autoimmune disease, our three-year data for the EVX01 melanoma program, our plan strategy with the EVX-04 AML program and the early work maturing in our preclinical EVX-B4 program against Group A Streptococcus. And fundamentally, we are driving the partnership strategy to focus on the platform and the assets so that we can continue to build value in the company and focus on delivering those into early development where we believe we can add value. So at this point, I'd like to hand over to Birgitta, who will talk you through our R&D and AI Immunology update.

Thank you, Helen. So today, I'll be focusing on our lead candidate, EVX01. And as mentioned, this is our personalized new antigen cancer vaccine currently in phase two in advanced melanoma. And then I will present the exciting new data demonstrating the scalability of our AI immunology platform into the hard-to-treat deadly brain cancer glioblastoma. And lastly, I will showcase how we have applied AI immunology to design optimized vaccine antigens for an improved polio vaccine. So if you take the next slide. So as Helen mentioned, we presented EVIX. or one phase two biomarker and T cell immune data at the ACR annual meeting here in April. And we reported that 86% of the EVX01 vaccine target triggered a specific immune response. And this is substantially higher than what has been reported for other similar vaccine candidates. Furthermore, we also reported that 86% of the immunogenic vaccine target induced a de novo T cell response, meaning that the EDX01 vaccine specifically triggers novel T cell responses and not just amplifying existing responses. And this is of great importance as induction of these novel responses have been linked to clinical benefits. Furthermore, we demonstrated a positive correlation between the predicted quality of the EVXO1 vaccine target and the magnitude of the T cell response induced by the vaccine target. And this high vaccine target success rate together with this positive correlation demonstrates the strong predicted power of our AI on multi-platform. If you take the next slide, so EVX01 continues to deliver strong data, adding to the already existing and promising clinical and immunological data page. So at ESMO last year, we reported a 75% overall response rate, including 25 complete responders and 92 sustained responses, indicating a doable benefit. So importantly, more than half of the patients converted into an improved clinical response upon EVXO1 treatment. And with the newly presented Phase II immune data, this further strengthens the picture with the 86% immunogenicity and the 86% de novo immune responses demonstrating broad and consistent immune activation. So looking ahead, we have a clear development trajectory. We will announce three year data including clinical outcome in the second half of this year. Further, we are evaluating and discussing additional relevant cancer indications and with further trials expected to be conducted in partnerships. And importantly, EVX01 has already received FTA fast track designation validating both the unmet need and then also the development potential. So all of this positions EBX01 very strongly as we move forward into the next phases of value creation. If you take the next slide. So let's turn our focus to the other promising data set presented at AACR. So in collaboration with Duke University, we demonstrated that our AI immunology platform scales beyond melanoma, and here it's exemplified with glioblastoma or GBM. So GBM is the most common and the most aggressive primary malignant brain tumor. And despite surgery followed by chemoradiation, outcome remains very poor for these patients with a median overall survival of approximately 15 months and a five-year survival below 10%. So using our AI immunology platform, we have evaluated tumor omics data from 24 GBM patients and demonstrated that a fully personalized vaccine design was feasible for all these cases. And importantly, these designs were based on two classes of antigens, so classical new antigens, and also antigens derived from the dark genome, so-called endogenous retroviruses or ERVs. So in 21 out of the 24 designs, they included both types of antigens. Two vaccine designs included only new antigens, and one design relied solely on the ERV antigens. And this analysis showcases the flexibility and the scalability of the platform to integrate antigen from different sources, fitting the patient tumor biology. So overall, the data demonstrate that AI immunology can address hard-to-treat, low-mutational burden tumors like DVM, and it also supports broader applicability of the platform across different cancers. If you move on to the next slide. So another example of how AI immunology can be used to design improved vaccine was showcased at the World Vaccine Congress. And together with the Gates Foundation, we presented new polio vaccine, a new polio vaccine concept using AI immunology. We designed a novel hybrid capsid antigen and a novel de novo diesel antigen with the aim of eliciting a strong and broad tumor response against all And overall, this highlights the potential of AI immunology to reinvent classical vaccines with improved simplicity and also improved breadth.

Take the next slide.

So having highlighted progress across the key R&D program, let's step back for a moment and focus on AI immunology and the data validating its ability to generate high-quality product candidates. So AI immunology is clinically validated with positive outcomes in three out of three oncology trials. And preclinically, we have demonstrated proof of concept across multiple disease areas, including cancer with our IRB targeting of the SHIELD vaccine concept, as well as in infectious diseases with several vaccine candidates targeting multiple bacterial and viral pathogens. And importantly, the EVX01 concept is highly scalable with potential in other solid tumors beyond Additionally, the platform's applicability in challenging cancer indications was further validated in GBM. So finally, AI Immunology supports multiple modalities, including peptides, proteins, and DNA and RNA, enabling broad pipeline and also partnership potential. So in conclusion, we have demonstrated strong progress across our platform and our R&D pipeline. And we are looking forward to keeping you updated as we advance our programs further. So with that, I will now hand over to Thomas, who will present our quarterly financial results.

Yes, thank you, Birgitte. And as mentioned, I will now then present and take you through our Q1 26 results. The highlights of the first quarter of the year really is a continued discipline that we have applied in our resource allocation, of course, aligned with our strategy and certainly investing into our value drivers. So really according to plan, and that also means that we are on track to deliver what we expect of an operational cash burn of roughly 14 million US for 2026. That also underlines and reconfirms that our cash runway is into the second half of 2027 and remains as such. Also, as earlier communicated, not assuming any partnerships or deals that we will hopefully be making and communicating within that time frame. Looking at the P&L, we have operating expenses overall more or less in line with last year, but slightly reduced. It comes from our R&D with a minor increase as we continue, as mentioned before, to progress and advance our pipeline and programs according to the plan. On the other side, our G&A expenses are slightly lower versus last year, also mainly driven by the fact that we have lower capital market costs in Q1 26 versus the same period in 25. The first quarter resulted in a net loss of 3.6 million US, again, according to our plan. On the balance sheet side of things on the next slide, And reconfirming once again, our cash position and equivalent end of the quarter stands at 18.4 million, which confirms the runway until the second half of 27. And the total equity has been reduced since year end, really as a result of the net result of the first quarter, meaning that we have 13.2 million US as equity at the end of the quarter. So all in all, financials according to plan, allocation into our main priorities, and cash runway confirmed until the second half of 2027. And with that, I hand it back to Helen for some concluding remarks.

Thanks, Thomas, and thanks, Birgitta. And so I would just like to emphasize that we believe we've made a great start to 2026. It's achieving the first of our milestones with really encouraging translational data from EVX01. We've got various presentations that have been made that validate the capabilities and scalability of the platform, as Birgitta has explained. Business development remains a key priority in terms of engaging with organizations on the value of the assets that we have and the capability to develop those assets, as we've talked a bit about. And the cash runway is maintained through to the second half of 2027. So we are rigorously following execution of our strategy and engagement externally and making great progress. So with that, I would like to hand back over to take some questions via the operator.

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again.

One moment for our first question.

And our first question comes from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead.

Hi, everyone. Thanks for taking the questions. Two for me. With respect to the three-year EVX01 data, ASCO is obviously too soon, but should we anticipate something like an ESMO readout, or will you do it independent of a broader scientific meeting?

So we will be updating in the context of a scientific meeting. We will not be sort of outside of that. That's not our intention, and we'll confirm which of the four conferences it will be once we're able to, once abstractions are released.

Got it. And then I think the GBM data that you put out, albeit early, was very exciting, obviously a disease state in great need. Is it your strategic intent to take that into humans, or would you seek a partnership based on the data you have now and perhaps some additional preclinical data?

So we are very excited about the data. We agree it's really interesting and it's really exciting in a very difficult to treat disease. We would anticipate that that will be something that we will be partnering. It sort of strengthens the overall personalized approach that we have developed with EVX01. But probably more to come on that as more data and discussions mature. But it would be a partnering approach for that one, too.

Got it. Appreciate it. Thank you.

Thanks for the question.

Thank you. Our next question comes from the line of Michael Okunowicz from Maxim Group. Please go ahead.

Hey, there. Good morning, everyone. Thank you for taking my questions today. Congrats on all the great progress. I guess to kick things off, I'd like to ask just a little bit about expansion and I guess your design philosophy and strategy around that. So, first off, when thinking about targets for expanded indications in cancer in particular, Is the plan to go after other diseases where PD-1s have historically been ineffective due to that synergistic activity of directing the anti-tumor immune response?

So I think we've taken a lot of parameters into account. But, Birgitta, do you want to comment on how we have been marshalling the approach internally to focus on the right diseases?

Yeah, so as mentioned, we are looking at multiple different antigen sources currently, and there's further development in this area in the company. So we would like to be able to provide a cancer vaccine for all patients independently of their antigen profiles or landscapes. So we have so far looked at more than 30 different indications mapping out their mutational burden, their ERV burden, et cetera, and can see that for many of these indications we're able to, with the capabilities we have currently, to design a high-quality vaccine. And of course, one would need to further dive into, yeah, medical need and current treatment landscapes to find the optimal subpopulations where our therapies would fit. But not necessarily in PD-1 low patient. It could also be in high. So it's mostly, we are mostly focusing on understanding the endogenic landscape and fitting our therapies towards these profiles.

And then when thinking about designing new vaccines, do you find that it makes more sense to use one personal vaccine and then see if you could expand that to multiple tumor types with the same vaccine for more universal coverage? Or does it make more sense to go tumor by tumor and create a new batch of targets that are directed specifically at the common targets for that given tumor type, like melanoma or like glioblastoma, and have an individual vaccine candidate for each of those different cancers.

So, the way that we are approaching this is to look into a lot of data from a certain indication and understanding, as mentioned, the landscape. If we do see that there are these conserved antigens, so antigens that are shared across patients, we would definitely develop a off-the-shelf vaccine, just due to the fact that the statistics are more simple and also the cost for the manufacturing would be way lower than for personalized approach. Further on, you can, if it's an off-the-shelf therapy, you can immediately treat the patients and not have to wait for that personalized batch to be ready. So that's the, everything comes back to the patient omics data and the profiles that we are seeing in our analysis. For some indication, we know that development and off-the-shelf cancer vaccine would be very challenging. And so it clearly depends on these different biological profiles.

And I think the EVX04 illustrates just where in that setting, Pegida, the high level of conserved has enabled us to produce a single vaccine for those patients.

Thank you. I appreciate the additional color, and I'm looking forward to the three-year data coming up later this year.

Yep. Thank you. Thank you. We will now take our next question. And this question comes from the line of Dania Van Hale from Jones. Please go ahead.

Hi. Congratulations on the update. Thank you for taking your questions. You mentioned that there are several parallel partnerships and discussions. Can you provide more detail on whether these discussions lean toward broad platform licensing or specific asset-based collaboration? Thank you.

So we obviously can't say much at this point. I think we have stated the priority around partnership on EVX01, but as you've heard, that has broader applicability than melanoma in our minds, and that is obviously also gathered interest externally with partnering conversations also. And across our infectious diseases portfolio, there are a number of assets there which are of interest to a number of companies. So we can't really provide any more details than that. I'm surprised to say that we are trying to be strategic around the way we have the partnering discussions in terms of maximizing the value, whether it's from an asset group in infectious diseases or the approach with something like the personalized EDXO1, EDXO3, cancer vaccines. Obviously, as soon as we can tell you all, we'll be delighted to do so, but we're pushing forward on a more strategic basis, if you will, around how to get the most value out of the assets that we can produce from AI immunology.

Thank you. And just one more question on the autoimmune platform part. So we should expect more details in the second half?

Yes, that's our current plan aligned to, as is always generally with evaction, generally aligned to scientific relevant conferences to report on data.

Perfect. Thank you very much. Looking forward. Thank you.

Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone.

That is star 1 and 1 to ask a question. There are no further questions for today.

I will now hand the call back to Helen Taiton-Martin for closing remarks.

Thank you. Thank you very much, and thank you to all those who listened in to the call, and thank you very much for the questions that we received. I think in summarizing, we are very enthusiastic and excited about the performance so far in Q1 2026. We are really just getting started and are achieving as we have stated them to be. So very excited about the initial data, very excited about the additional updates to come later this year. And with that, I'd like to thank you very much, and I think we'll be closing the call.

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