EVAX

Good day. 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 one and one on your telephone. You will 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 speaker today, CEO Helen Tayton-Martin. Please go ahead.

Thank you, and welcome everyone to Evaxion's Q1 2026 Business Update Call. I'm very pleased to be joined today by our CSO, Birgitte Rønø, our COO, recently promoted, we'll talk more about that, and Thomas Schmidt, our CFO, and our Head of Investor Relations and Communications, Mads Kronborg. 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 Birgitte, who will talk through some of the recent highlights from our R&D portfolio on AI-Immunology platform.

Birgitte will hand over to Thomas, who will walk you through our Q1 financial results. Then we will have some concluding remarks before opening up the call for Q&A. 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 filed documents. If I go past our introduction to slide 5. 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, somewhat, and 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 Evaxion can deliver in terms of products and, the platform. 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. Secondly, in our R&D focus areas, we're delighted to talk about our recent data from our EVX-01 lead program phase II study in which we were able to update some of the translational data recently at AACR.

Birgitte will talk more, 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. That is very much part of how we were able to demonstrate the broader applicability of the platform in Glioblastoma. Again, Birgitte will speak more to that.

Finally, we were able to confirm the completion of the last patient, last visit in the extension phase of our EVX-01 program and our phase II trial. 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 in autoimmune disease, again, where we'll update later in the year. 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.

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 6. As mentioned, we have reorganized slightly inside the organization. I'm delighted to announce the promotion of Birgitte Rønø to the combined role of CSO and COO, which really reflects on how we organize 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 interactions. Separately and in parallel, we were able to welcome Jens Bitsch-Nørhave to our board of directors.

Jens Bitsch-Nørhave comes to us with a huge amount of experience in BD and corporate strategy and outreach in general, both from a biotech perspective, but more recently from J&J and Homrie, where he is currently Corporate VP and Global Head of Corporate Development. 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. On slide 7, 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. Andreas continues to support and drive the organization's innovation strategy around AI-Immunology.

Our board remains the same, but with the addition of Jens, as I mentioned. Moving to slide 8 to set up our objectives and key milestones for this year. Just a reminder that Evaxion, over many years, now has the privilege of having a pipeline in phase II in oncology with our EVX-01 asset in advanced melanoma, our personalized neoantigen-directed peptide-based vaccine, where we've got great data, which Birgitte will touch on in terms of now and what to come. We have our EVX-03 program, which is a combination of personalized and ERV-based antigens on our DNA platform. Then we also have coming along in preclinical development, aiming for clinical readiness by the end of this year, our off-the-shelf vaccine program, EVX-04, 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, EVX-B1, against pathogen Staphylococcus aureus, our EVX-B2 program, against Neisseria gonorrhoeae. Also in collaboration with Aphrogen on an RNA platform. EVX-B3, our optioned partnered program, continues to move forward with MSD. EVX-B4, our more recent newer program on Group A Streptococcus is making great strides in initial early discovery component design. Our first viral program is continuing to make progress in terms of confirming the candidate components. A lot going on in the organization. In slide 9, just wanted to remind the audience of our 2026 milestones and the fact that we have achieved the first one of those in our EVX-01 additional biomarker and immunogenicity data.

We remain on track in terms of updating on the approach of AI-Immunology in autoimmune disease, our 3-year data for the EVX-01 melanoma program, our planned strategy with the EVX-04 AML program, and early work maturing in our preclinical EVX-B4 program against Group A Streptococcus. 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. At this point, I'd like to hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.

Thank you, Helen. Today I'll be focusing on our lead candidate, EVX-01. As mentioned, this is our personalized neoantigen cancer vaccine currently in phase II in advanced melanoma. 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. Lastly, I will showcase how we have applied AI-Immunology to design optimized vaccine antigens for an improved polio vaccine. If you take the next slide. As Helen mentioned, we presented EVX-01 phase II biomarker and T cell new data at the AACR annual meeting here in April. We reported that 86% of the EVX-01 vaccine target triggered a specific immune response. 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 EVX-01 vaccine specifically triggers novel T cell responses and not just amplifying existing responses. This is of great importance, as induction of these novel responses have been linked to clinical benefit. Furthermore, we demonstrated a positive correlation between the predicted quality of the EVX-01 vaccine targets and the magnitude of the T cell response induced by the vaccine targets. This high vaccine target success rate, together with this positive correlation, demonstrates the strong predicted power of our AI-Immunology platform. If you take the next slide. EVX-01 continues to deliver strong data adding to the already existing and promising clinical and immunological data package.

At ESMO last year, we reported a 75% overall response rate, including 25 complete responders and 92 sustained responses, indicating a durable benefit. Importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. 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. Looking ahead, we have a clear development trajectory. We will announce 3-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. Importantly, EVX-01 has already received FDA Fast Track designation, validating both the unmet need and then also the development potential.

Overall, this positions EVX-01 very strongly as we move forward into the next phases of value creation. If you take the next slide. Let's turn our focus to the other promising data set presented at AACR. In collaboration with Duke University, we demonstrated that our AI-Immunology platform scales beyond melanoma, and here it's exemplified with a glioblastoma or GBM. GBM is the most common and the most aggressive primary malignant brain tumor. Despite surgery followed by chemoradiation, outcome remains very poor for these patients, with a median overall survival of approximately 15 months and a 5-year survival below 10%. 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.

Importantly, these designs were based on 2 classes of antigens, classical neoantigens and also antigens derived from the dark genome, so-called Endogenous retroviruses or ERVs. In 21 out of the 24 designs, they included both types of antigens. 2 vaccine designs included only neoantigens, and 1 design relied solely on the ERV antigens. This analysis showcases the flexibility and the scalability of the platform to integrate antigen from different sources, fitting the patient tumor biology. Overall, the data demonstrate that AI-Immunology can address hard to treat low mutational burden tumors like GBM, and it also supports broader applicability of the platform across different cancers. If you move on to the next slide. Another example of how AI-Immunology can be used to design improved vaccine was showcased at the World Vaccine Congress.

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 T cell antigen with the aim of eliciting a strong and broad humoral response against all serotypes. Overall, this highlights the potential of AI-Immunology to reinvent classical vaccines with improved simplicity and also improved breadth. Take the next slide. 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. AI-Immunology is clinically validated with positive outcomes in three out of three oncology trials.

Preclinically, we have demonstrated proof of concept across multiple disease areas, including cancer with our ERV targeting off-the-shelf vaccine concept, as well as in infectious diseases with several vaccine candidates targeting multiple bacterial and viral pathogens. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors, so beyond melanoma. Additionally, the platform's applicability in challenging cancer indications was further validated in GBM. Finally, AI-Immunology supports multiple modalities, including peptides, proteins, and DNA and RNA, enabling both pipeline and also partnership potential. 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. With that, I will now hand over to Thomas, who will present our quarterly financial results.

Yes. Thank you, Birgitte. As mentioned, I will now 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. Really according to plan, that also means that we are on track to deliver what we expect of an operational cash burn of roughly $14 million 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 plan. On the other side, our G&A expenses are slightly lower versus last year. Also, mainly driven by the fact that we have had a lower capital market costs in Q1 2026 versus the same period in 2025. The first quarter resulted in a net loss of $3.6 million USD, again, according to our plan.

On the balance sheet side of things on the next slide, reconfirming once again, our cash position and equivalent end of the quarter stands at $18.4 million, which confirms runway until the second half of 2027. 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 as equity at the end of the quarter. All in all, financials according to plan, allocation into our main priorities, and cash runway confirmed until the second half of 2027. With that, I hand it back to Helen for some concluding remarks.

Thanks, Thomas, and thanks, Birgitte. I would just like to emphasize that we believe we've made a great start to 2026 achieving the first of our milestones with really encouraging translational data from EVX-01. We've got various presentations that have been made that validate the capabilities and scalability of the platform, as Birgitte 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. The cash runway is maintained through to the second half of 2027. We are rigorously following execution of our strategy and engagement externally and making great progress. With that, I would like to hand back over to take some questions via the operator.

Thank you. 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 3-year EVX-01 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?

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. We'll confirm which of the 4 conferences it will be once we're able to once abstracts are released.

Got it. 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?

We are very excited about the data. You know, 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 EVX-01. Probably more to come on that as more data and discussions mature. It would be a partnering approach for that one too.

Got it. Appreciate it. Thank you.

Thanks. Question.

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

Hey there. Good morning, everyone. Thank you for taking my questions today. Congrats on all the great progress.

Thank you.

I guess to kick things off, I'd like to ask just a little bit about Evaxion 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-1 have historically been ineffective due to that synergistic activity of directing the antitumor immune response?

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

As mentioned, we are looking at multiple different antigen sources currently. There's a further development in this area in the company. We would like to be able to provide a cancer vaccine for all patients, indicant independently of their antigen profiles or landscapes. 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. Of course, one would need to further dive into medical need and current treatment landscapes to find the optimal subpopulations where our therapies would fit. Not necessarily in a PD-1 low patient, it could also be in high. We are mostly focusing on understanding the antigenic landscape and fitting our therapies towards these profiles.

Mm-hmm. 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? Does it make more sense to go tumor by tumor and create a new batch of targets that are directed specifically at the common target for that given tumor type, like melanoma or like Glioblastoma, and have an individual vaccine candidate for each of those different cancers?

Oh, not again. Yeah.

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 that are shared across patients, we would definitely develop a off-the-shelf vaccine just due to the fact that the logistics are more simple and also the cost for the manufacturing would be way lower than for a personalized approach. Further on, you can, since 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. That's everything comes back to the patient omics data and the profiles that we are seeing in our analysis. For some indication, we know that developing an off-the-shelf cancer vaccine would be very challenging. It clearly depends on these different biological profiles.

I think the EVX-04 illustrates just where in that setting, Birgitte, the high level of conserved has enabled us to produce a single vaccine for those patients. Yeah.

Thank you. I appreciate the additional color. I'm looking forward to the 3-year data coming up later this year.

Yep. Thank you.

Thank you. We will now take our next question. This question comes from the line of Tania Vanmale from Jones. Please go ahead.

Hi. Congratulations on the update. Thank you for taking our 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.

We obviously can't say much at this point. I think we have stated the priority around partnership on EVX-01, but as you've heard, that has broader applicability than melanoma in our minds. That has obviously also gathered interest externally with partnering conversations also. Across our infectious diseases portfolio, there are, you know, a number of assets there which are of interest to a number of companies. I We can't really provide any more details than that.

Suffice 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 a personalized EVX-01, EVX-03 cancer vaccines. We obviously will, as soon as we can tell you more, we will be delighted to do so. But we're well 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. Just a 1 more question on the Autoimmune platform part. We should expect more details in second half?

Yes. That's our current plan aligns to, as is always generally with Evaxion, 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 one and one on your telephone. That is star one and one to ask a question. There are no further questions for today. I will now hand the call back to Helen Tayton-Martin for closing remarks.

Thank you. Thank you very much, and thank you to all those who listened in to the call. 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 our milestones as we have stated them to be. Very excited about the initial data, very excited about the additional updates to come later this year. With that, I'd like to thank you very much, and I think we'll be closing the call.

Thank you. This concludes this conference call. Thank you for participating. You may now disconnect.

Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Full Year 2025 Financial Results Webcast and Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please go ahead.

Thank you, and good morning, everyone. Thank you for joining us for Evaxion's business update following the reporting of our 2025 full year financial results yesterday. And apologies that this call is 24 hours later than we anticipated for technical reasons, we are delighted to be here today. My name is Helen Tayton-Martin, and I am honored to be leading this call for the first time as Evaxion's CEO. We move to the first slide. Okay. So on today's call, we will review the achievements of 2025 and touch on the milestones we anticipate for 2026. Our Chief Scientific Officer, Birgitte Rono, will then walk through our key R&D updates for the year, including the latest innovations from our AI immunology platform, after which our CFO, Tom Schmidt, will walk through our 2025 financial results before we close with a few concluding remarks and take questions. Right. Moving to the next slide. And of course, our comments and presentation today may contain forward-looking statements and all references on today's call, I'll refer to our filed SEC statements and specifically, our most recent 20th annual report for 2025 -- 2025 filed yesterday. So moving to the next slide. I will start with our 2025 achievements and our 2026 milestones. In 2025, we were very pleased to report tremendous progress across all pillars of the company. First of all, in business development, we were delighted with the progress in our collaboration with MSD and our infectious disease portfolio, with the decision by Merck to exercise its option over our EVX-B3 program candidate. Whilst the target for this program is not disclosed, we are very proud that this represents the first in-licensing to our knowledge of an infectious disease vaccine candidate identified and validated to an AI discovery platform. Whilst MSD chose not to exercise its option over our EVX-B2 candidate in gonorrhea, we remain very excited about the data and the prospects for this program, over which we have retained full rights and have seen significant interest. We were also pleased to enter into a collaboration with the Gates Foundation on the design of a new polio vaccine and are also seeing significant interest in our platform and pipeline programs more broadly from a number of parties. In R&D, we were very pleased to be able to present very positive [ to ] Phase II data at ESMO on our EVX-01 program with a personalized neoantigen-directed cancer vaccine in advanced melanoma patients. We also presented preclinical data at ASH on our first cancer vaccine we shared [ at antigen directed ] to a conserved endogenous retroviral EBR elements that we have identified in AML patients with our EVX-04 program. In our infectious disease portfolio, we were also able to move forward a new program with candidates identified from our AI immunology platform against [ Group A strep Coke ]. On the platform itself, the team has continued to innovate and use platform to not only identify optimal vaccine candidates, but improve their design biology for product delivery for us in our new automated module. And Birgitte will touch on all of these achievements shortly. We were also honored by the recognition of our AI immunology platform by the Galien Foundation for AI advances in human health. And finally, we were very pleased to see the capital influx of the business last year through financing, business development and the use of our ATM, which now gives us action a cash runway to the second half of 2027. And Thomas will talk more to this later. So moving to the next slide. Just as a reminder, our action has built a broad novel product basis pipeline of assets from its unique AI immunology platform. clinically validated with the cancer vaccine space with our EVX-01 [ peptide ] base vaccine in advanced melanoma that's supported by assets and data on DNA and RNA platforms and together with a preclinical pipeline of infectious disease vaccine candidate, focused on challenging targets remaining intractable with conventional approaches and subject to significant medical need. On to the next slide. This unique capability with AI immunology is something that we have also begun to investigate within the autoimmune field, given a wider range of diseases driven by autoimmune attack and the direct applicability of our platform to focus on immune mechanisms in disease. Autoimmune diseases affected over 14 million patients annually in the U.S. and are characterized by chronic debilitating conditions with treatment options focused primarily on the symptoms rather than the underlying cause of disease. Moving on to the next slide. This is why we believe our AI immunology platform is strongly positioned to focus on underlying disease mechanisms with greater specificity to identify autoimmune disease targets, which can be approached in different ways. There will be more to come on this later in the year. So finally, in the next slide, turning to our 2026 milestones. This year, we will be updating on our EVX-01 program with additional biomarkers and immunogenicity data, AACR and then the clinical data, 3-year data towards the [ later ] towards the end of the year. Well, we will be talking more about the autoimmune applications of our AI immunology platform and bringing forward data on our new EVX-B4 candidate in Group B [ rubric ] in the second half of the year. And finally, be ready to submit a regulatory application for our next EVX-04 candidate vaccine candidate for the shared her antigens in AML by the end of the year. And throughout, we remain committed to driving value from both our platform and our pipeline assets to partnership for our shareholders and patients. I'll now hand over to Birgitte to update you further on our R&D achievements.

Thank you, Helen. So 2025 marked a turning point with significant advancement across our R&D pipeline and also and our AI platform. And additionally, as Helen alluded to, we also entered into the in-licensing agreement with MSD on the EVX-03 program. So our 2025 focus has been on strengthening our platforms predictive power, maturing key R&D assets and are building the foundation for future partnerships. So the 2025 achievements position us well as we move towards the data with milestones in 2026, that Helen just presented. So with that, I will begin by walking through individual key programs and platform development. So next slide, please. [ EVX-01 ], our personalized peptide-based cancer vaccine in advanced melanoma continues to deliver strong clinical data. So our 2-year Phase II data presented at an oral session at ESMO in October showed strong clinical outcomes, including a high objective response rate of 75% and complete response rate of 25%. Notably, 92% of the responders remained in response at this 2-year mark. Key biomarker data included the very high [ immunogenicities ] rate with 81% of all the individual new antigen administered across patients, giving rise to a specific T-cell response. So this very impressive heat rate outcompete data from similar programs conducted by others. And this truly underlines the precision of our AI immunology platform, to identify better than vaccine targets. Two key milestones are expected for this program, as Helen also alluded to, additional biomarker and [ genicity ] data expected in the first half of '26, and we also plan to communicate the 3-year data from a subset of patients that are currently in expansion part of the Phase II study, and that will be reported in the second half of '26. So importantly, we aim to conduct future trials in partnership ensuring the broadest possible impacts for patients. So moving to the next slide and EVX-04, our after-shelf therapeutic vaccine for acute myeloid leukemia or e-mail, we have generated a compelling preclinical base evidence supporting its development. In this program, we are focusing on a completely novel class of tumor antigens, so-called endogenous retroviruses or ERVs that are selectively and highly expressed in AML blast, making them attractive as therapeutic targets. So with AI immunology, we have identified millions of shortages from patient sequencing tumor data and designed the [ EVX-04 ] vaccines with 16 optimal ERV [ anti fragment ] selected based on craft patients [ pellets ] and also on the immunological potential. So key data include invite vaccination studies, demonstrating that all of these 16 fragments in the vaccine induced a strong specific immune response and further that EVX-04 prevents tumor growth in several of our tumor [ virus ] and induce strong T-cell responses. So again, these findings reinforces the power of our platform. And here, we have expanded it to uncover unique tumor antigens that are not accessible through traditional discovery methods. Next slide, please. As we progress towards clinical business for EVX-04, we have completed key steps, including antigen selection and lead development we have conducted preclinical efficacy studies and are currently conducted further human cell-based translational assays. CMC work and GMP manufacturing are advancing according to plan. And the next major milestone for this program is the submission of the clinical trial application in the second half of '26, which enabled first in human system. So this program is a prime example of how AI immunology accelerates vaccine design from concept to clinic. So next slide, please. Now turning to our key indexes disease programs. So after retaining the full global rights to EVX-B2 late last year, we are now fully in control of the development of this highly differentiated vaccine candidate targeting -- gonorrhea. So our preclinical data package is strong and comprehensive demonstrating significant protection in a mouse infectious model. We have demonstrated broad efficacy against 50 clinically relevant -- dates reflecting coverage across diverse strengths and further induction of significant [ una ] and cellular responses in mice, and we have also demonstrated a well-established mechanism of actions supported by potent antibody-dependent complement-mediated killing. So collectively, these results position EVX-B2 as one of the most advanced and differentiated infectious disease preclinical gonorrhea vaccine candidates in an area of high unmet need where no approved vaccine exists today. So given the strength of our data, we see a clear opportunity to engage with potential partners to progress the program towards clinical development. So next slide, please. So a number of our key infectious disease vaccine program is EVX-B1. In this program, we are developing a margin target vaccine against cytomegalovirus or CMV and instead of relying on a single glycoprotein or limited set of glycoproteins, the program integrates both these well-described glycoprotein and novel antigens to target the prior -- from multiple complementary angles. So this broad multicomponent strategy is designed to enhanced vaccine efficacy and also to reduce the risk of viral escape. So we have applied AI immunology for both antigen optimization of the known glycoproteins and for identification of 2 novel antigens. So first, we improved these established CMV antigens that are essential for virus neutralization. And as part of this, we have engineered the glycoprotein B antigen, by locking in a prefusion state. And this AI analogy designed a construct has demonstrated a superior neutralization capacity compared to the native program. And secondly, we are identifying and validating entirely novel antigens and several of these -- they have already demonstrated the ability to inhibit [ Vinten ] further, we are characterizing them at the moment. So supported by this strong preclinical data, EVX-B1 represents a highly promising program for continued development and for future partnership discussions. Next slide, please. So now turning to the recent development of our AI-Immunology platform. So our AI-Immunology platform continues to expand capability. So the platform integrates [ multiomic ] data sets to generate ranked antigen lifts within 24 hours. So in October last year, we launched a an automated vaccine design module enabling sequence and structural optimization directly from this short-listed engines. At this end-to-end automation significantly reduced cost development time and also this. So next slide, please. So more specifically, the automated module enhances design of [ Sage ] antigen constructs, enabling higher expression, better formulation and improved manufacturability. So this capability directs the design of [ salable ] antigen constructs and also stabilizing antigens using in various posing producing more reliable antigen construct vendor, wire side variance. There is a faster and more cost-effective design cycle fully integrated into our antigen discovery and vaccine optimization workflow. So this strengthened the foundation for all of our programs across oncology and infectious diseases. So in conclusion, we have seen strong progress across our platform and our R&D pipeline, and we are encouraged by the momentum and we look forward to keeping you updated as we advanced to 2026. And with that, I will now hand over to Thomas, who will go us through our financial business.

Yes. Thank you, Birgitte. And also a warm welcome from my side to our call today. And I will now walk you through the financial results for 2025. So turning to the next page. We have, throughout 2025, been really successful in expanding on our cash runway and also strengthening on our equity side. This has happened throughout the year through public offering and the use of ATM we did in January, followed by the MSD exercise fee and the ATM used in September. And furthermore, the exercise of investor warrants from our January offering in October and November, all summing up to a cash inflow of USD 32 million. Furthermore, as also shown on this slide, our EIB debt-to-equity conversion done in July of USD 4.1 [ billion ]. We've reduced certainly our cash -- future cash out and thereby certainly also expanding and extending our cash runway. And finally, with our filing in December of our prospectus supplement regarding our ATM. It has now created us with further flexibility ability and options as we move forward with expanding our pipeline and platform also. So really, really underlines the strong execution throughout the year. And turning to the next slide. that also leads into the highlights of 2025, where we really have delivered on all the targets that we set and we are progressing towards our aim of becoming a sustainable self-funding business. Both revenue and costs have improved while at the same time, we are continuing to invest in our platform and in our pipeline programs. As just mentioned on the previous slide, activities and execution of the MSD deal, the EIB debt conversion, our ATM and capital market activities have not only improved our cash position and runway, but has also significantly strengthened our equity. And with improved cash runway and equity -- equity we have created more stability and certainly have also reduced uncertainty. So I think that is really, really also a highlight for '25. And again, with the update of [ F3 ] and ATM, we have removed the constraints of baby shelf and also provides us far better flexibility and options in support of our long-term strategic initiatives and also the long-term plans we do have. Next slide. is on our profit and loss statement. As I just mentioned, revenue has improved, but also we've improved on our operational costs. So we've actually been successful in long in our operational spend whilst at the same time delivering on the quality that we would want to do from a pipeline and platform perspective. revenue certainly stems from our NST option exercises, but also important to mention, we also had a grant from the Gates Foundation that also has come in 2025 -- apologies. Net financial position of [ $4.6 million ] is driven by a premium that we received from -- our debt conversion -- debt-to-equity conversion from [ EIB ] and against that goes remeasurement of a derivative liability as some of our warrants or our [ launch ] from the public offering in January were in a different exchange setting, so the USD versus our reporting of DKK. Net loss for the year, [ $7.7 million ], certainly a better in compared to last year. And as I said before, also a good step on the way of becoming a sales funding and profitable business. Next slide, on the balance sheet. since we ended the year with a cash position of USD 23 million with a runway that now is extended into half year 2 of 2027 in certainly also a significant improvement compared to last year. And this, of course, will be used for operations expenses and investing into our platform and pipeline. We currently have an outstanding -- we have a total outstanding ADS of $8.3 million when assuming that all shares have been converted into ADSs. We've also, through the investor warrants exercise has been reducing the outstanding warrants in terms of ADSs by $1 million. which leaves another [ 2.8 million warrants ] outstanding. So also an improvement in that and really drives in the right direction. So in summary, from a financial position, we have during 2025, established a far better foundation that really makes us puts us in a good position to continue our execution of strategy and business for '26 and the years beyond. With that, I hand it back to Helen for some final concluding remarks.

Thanks, Thomas. And just moving to the last slide. In summary, 2025 was a year of strong operational momentum for Evaxion, in which we achieved several key milestones. Overall, we strengthened the business considerably to the validation of our strategy with our AI-Immunology platform, delivering on both data and partnerships. This, in turn, has enabled us to both strengthen our financial position and consolidate our position as a leader in AI-based of discovery, design and early development. With a number of potential partnership discussions ongoing, we are already funded into the second half of 2027 through the financial milestones achieved in 2025. So we're in a good position to move forward through 2026. With that, I'll hand over to the operator for questions.

[Operator Instructions]. Our first question today comes from the line of Thomas Flaten from Lake Street Capital Markets.

Maybe to start broadly, Helen, you've been in the seat now for a few months. I'm just curious if you could provide some overarching commentary on what you have implemented or are going to implement -- any changes in strategy? And any bigger picture notes like that, that could help us with the context of your tenure?

Sure. Thanks. Thanks for the question. Yes, I joined at the end of November last year. So the last 3 months have flown by. But I already have a strong impression from my prior seat on the Evaxion Board. In terms of bigger picture, changes. I think the fundamental action remains really strong. And in fact, I think they have only got stronger through 2025. So the ability to have an AI platform that is built up over many years, many iterations, grounded in data and testing for that data in the lab, and ultimately in the clinic has really strengthened the core offering. So I remain really excited about the power of the platform in the oncology space and also in the infectious disease space. And I think we're sort of seeing a lot more traction around what we can do with the platform now from external engagement. So I think the fundamental strengths and core of what Evaxion has to offer is even stronger now than potentially before. And I think in a world of AI, everything, actually getting to products, actually producing candidates that can generate vaccines that generate a biological response and the clinical response is meaningful and is becoming recognized as meaningful, certainly in our partnering conversations, et cetera. So I think that, that is core. So clear observation I had before coming into the company and certainly strengthened by all my observations within it. and even more impressed by the team that's in place that can deliver on this. I think in terms of the overall strategy, what have Evaxion has done well is that early discovery, the early validation, that deep scientific and informatic embedded expertise, and we can certainly bring things forward into early clinical development, late preclinical, early clinical. And I think what we're going through at the moment is a process of really optimizing where we see the most value in the near term, both in terms of our oncology assets, but also within the infectious disease area. I think we are not positioned to take too much further forward into the clinic. So we've been very cautious about that but we certainly see strength in getting interest from external parties around the assets that we've already got. And actually, the capability of the platform. So there's not a fundamental change to strategy, but I think a sharpening and the deepening of focus around the assets that will have the most value. I hope that's helpful.

Yes, that's great. And just keying off of your last comment there about taking products into the clinic. You mentioned with EVX-04 in Birgitte's presentation that you would be looking to submit regulatory paperwork. Is that a product that you think you have to take into Phase I given that herbs are a bit new, a bit different in order to attract a partner interest?

I think that's a very good question. We are certainly preparing to take it into the clinic, and we believe that we can do that to gain some initial proof of concept. There's a lot of interest around the platform at that particular metacandidate antigens in the vaccine. I think we're doing some further validation, which I think will continue to strengthen it. So the answer in short is not necessarily, but clearly, the more critical validating data that we can add to the package. The stronger the value proposition to an external partner, and that's obviously what we're all about is maintaining the -- building the value for as long as we can to strengthen our position. And I think we're very confident about what we can do with it preclinically and potentially clinically.

Our next question today comes from the line of Michael Okunewitch from Maxim Group.

Congrats on all the great progress you made. I guess to start off, I'd just like to see if you could comment a little bit on the partnering efforts for EVX-01. And in particular, if there's anything that you've heard either in your feedback from partners that you think you're still would be particularly important for us to watch for from the upcoming data releases, whether that's the 3-year data or the biomarker immunogenicity. Is there anything in particular you think is key for driving these partnering discussions?

So that's a really good question. And I mean, clearly, the cancer vaccine space has had something of a checker passed -- way back, but more renaissance, I think, in the checkpoint era. And I think our data is certainly resonating with companies who are interested in the cancer vaccine area, understand the nuances around getting, I think, strong cancer -- antigens, [ presliced ] cancer antigens for not just immune recognition but for clinical benefit. So the -- it is a complex therapy to administer, but it is also potentially an effective therapy. And I think the sorts of things that gain interest of the -- not just the response rate that we've seen in 2 years, 1 year than 2 years at ESMO, but also the recognition of the antigens, the numbers that the [indiscernible], and I'll ask you to add comment to this as well. So I think the -- we're in a strong position with that updated clinical data package that we have, the translational data, I think it's going to be interesting. It continues to -- so why and how the immune response is happening in parallel to the clinical response. So that is, I think, a differentiator and also in the population, the advanced population rather than adjuvant melanoma population. And clearly, I think we're also seeing interest in this whole approach in other high mutational burden cancers too. So beyond melanoma knows of it. I think those are the differentiators thinking about where else this is applicable accolading the different biological parameters, the translational insights that we're seeing that's somewhat different to how others have reported on this with similar approaches. So quite a bit of interest. I think the number -- to be honest, a number of companies are on the fence, but we're looking with interest and very interested in the shared approach -- the share approach that our EVX-04 program offered. Birgitte, do you want to add some further comments?

So there's no doubt that the ability of our AI immunology platform to identify the relevant targets and is getting a lot of interest from potential partners and also from the academic community. And with this 81% hit rate, as we call it, I think this is very impressive. We have, of course, looked at other similar programs and seen that most of them are reporting hit rates way below 60%, meaning that the antigens that they are including in their vaccines are not all able to induce a specific T cell response. And this is, of course, a testament to the position of our platform. So that's one of the key elements. And another point that I would like to make is that we do see EVX-01 as not just a therapy for advanced melanoma. We believe that the same concept can be very useful in other occasions where there are a high mutational burden, meaning that there are several antigens to choose from. That includes many of the high prevalent cancer indications. It could be non-small cell lung cancer and also some of the colorectal cancers.

Thank you. I appreciate that additional color on that. And then as a follow-up, I wanted to ask if you could provide a bit more color on how you're applying the AI immunology platform to autoimmune disease. You identified this as a new area of interest. And do you expect that this would be more focused on allergies? Or would you focus more on the major large autoimmune and inflammatory diseases. Any additional color you could provide on that would be helpful?

Sure. I think the first thing to say is it's early in terms of our prioritization of the indications, but we've certainly done some work around that based on parameters, which I'll -- Birgitte you're happy to comment on that, I think, high level in terms of what's guiding where we focus will be -- that would be good.

Yes. So we have done a lot of analysis on most prevalent autoimmune diseases, and we do see a clear fit for our platform. I mean, we, of course, need to further improve it and build a few additional smaller unit that allows us to apply the immunology. But we do have many things in place that can be directly applied in this area. So we will, of course, share more when we have done both analysis on which key indications we will pursue and also when we have done a little bit more work on adjusting AI-immunology, so it fits these diseases. But we should remember to say that there's a lot of these smaller units we call them building blocks that we can directly apply for these tax of diseases. So not only for autoimmune diseases but also for other diseases where there is a strong immunological component. So of course, we need to build a little bit, but the majority is already in AI-Immunology.

Our next question today will come from the line of RK from H.C. Wainwright.

Thank you. This is RK from H.C. Wainwright. Just to start off, Helen, a quick question for you. You have basically, we've been an architect and multibillion dollar balances at that [ immune ] especially the large deal that was transacted with GSK. And also, you have heard a lot of experience in transactions. And while Evaxion is technically a very strong company, they have always had a difficulty in translating that language into meaningful transactions. Of course, Merck is a pretty strong partner. Based on your experiences, and how you manage to translate that. What sort of discussions could you have at this point? especially when talking with large-cap pharma, I'm convinced them that an AI tools predictability is as good as a physical assay and get them to start looking into some of the products that Evaxion is generating.

Thanks for the question. I think there are probably multiple dimensions to answer that question to the extent that it is possible to answer it at this point. One is that A lot of this is to do with timing. It's to do with data that validates that it's more than a sort of an AI platform. And I think actually, the fact that we have the scope to validate and iterate candidates target discovery with candidate development with cancer validation is something really novel that we're generally out there. And when I said timing -- there are obviously many of the large pharma, most of them will all have in-house AI platforms running in one form or another. But I don't think there are many that have got this sort of integrated long sort of longitudinal depth of expertise that actually has. So really, is that this is about crystallizing the offering through the validation of the cannabis we have and sort of being in dialogue with the right people. And you mentioned my background was a long time, 17 years in my precise company, building relationships establishing contact, understanding and listening to strategy, looking at the wider picture. These are all things that are very much part of how deals get done. And ultimately, it's down to relationships and credibility and really having something that fits the need. And all I can say at this point is we're reworking up some of those approaches and some of those themes in terms of how we are approaching potential partnering interaction, I have to say that the action team is well known with quite a few of these groups, but we're building and expanding that profile. And I think that's critical to the future success in partnering conversations. So it's being what you say you are in front of the right...

Perfect. Then going into relationships with Merck, especially regarding EVX-B2, Merck decided to extend the evaluation of the molecule rather than exercise the option at this point. Is this a function of them trying to do additional experiments or functional assets? Or are they requesting from new additional work so that they can come to a conclusion?

Sorry, are you referring to the extension that they had last year before the opt decision there?

Yes, yes.

I mean we can't really comment on, obviously, the combination nature of the interactions. All I can say is that sometimes is sort of R&D programs when they are back and forth and shared between organizations don't always run to plan. And so sometimes that requires looking at things again. But ultimately, then there are time frames around things, which have to follow through. So I think there are reasons for not taking sort of obviously, their reasons not multidimensional. All I can say is that we remain really excited about the data. We actually continue to build data on the program internally throughout that period of time as well. So we feel very, very bullish and strong about the data package but how and why I wanted to do that work? Or is it something we probably we can't really add any more commentary on.

Okay. On the EVX-01 durability, Birgitte, so you have shown 92% of the responders showing sustainability, be it 24 months. As we are looking forward to the 3-year durability what sort of exhaustion markers are you going to be tracking so that we understand how well the durability is.

Yes. Thank you for that question,. So it's correct that 92% of the responders remained in response with this 2 year mark. And I guess your question was related to the T-cell extortion -- as yes, we do a deep scar profiling, looking at activation marker, extortion markers and also at different phenotypes of the T-cells, so including CD4, CD8, but also looking into whether there are regulatory T-cells coming up. And so far, we have demonstrated that -- the profile of the T-cells are very favorable. So in more of the activation or effective type of sales and not too many that are having exhaustion markers. We also see that there's a like dominance of CD4 T-cells and with some patients are also mounting a CD8 T-cell by time. So we have -- during this extension phase of the study, we have been collecting additional blood samples that are currently being analyzed in our lab. So not to comment on that, but it's very exciting. And since EVX-01 is giving us a immunotherapy in this extension phase, we're also very curious of understanding what EVX-01 can drive on its own without having the background of the checkpoint inhibitors.

Okay. One last question from me. This is on the EVX-04...

In the interest of time, we will move to our next question. And our next question comes from the line of Daniel Ben Hill from Jones.

On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates?

Thanks for the question. I mean it's early, and we probably cannot provide more details. But, Birgitte, do you want to comment on how we think about it.

Yes. So the first step is to settle on an indication. So we have done landscaping. We've done dianalysis on looking at the top 10 most prevalent ultimate diseases, and we are now narrowing down which one could be the most, I would say, interesting from a -- from our perspective, where there is a nice fit for AI-Immunology. And so that work is ongoing. We've almost completed it. And next step is to focused on building the additional smaller units that we will be needing in AI immunology to enable us to develop therapies for these diseases. And in parallel, we are also sitting on mouse models in our lab, so ensuring that we can also test the candidates that AI-Immunology is designing. So that is the current plan. So pretty traditional way of analyzing our existing the candidates that AI immunology is designing.

Thank you. This concludes today's question-and-answer session. I will now hand the call back to Helen Tayton-Martin, CEO, for closing remarks.

Thank you very much for everyone participating on the call today. It's been a great year of 2025 of transforming the company for Evaxion delivering on multiple milestones, leaving us in a stronger financial position than for some time, where we hope we can take the company forward and deliver on our 2026 milestones and continue to strengthen the value that comes from the platform and the asset. So thank you for your questions and your engagement, and we look forward to our next update. Thank you. Bye-bye.

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

Hello, and welcome to the Evaxion Business Update and Third Quarter 2025 Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand over to Birgitte Rono, Interim CEO and CSO. Please go ahead.

Thank you. Good morning and good afternoon, and thank you all for joining our Q3 2025 business update and financial results conference call. I'm Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. I'm joined today by Thomas Schmidt, Chief Financial Officer; and Mads Kronborg, Vice President of Investor Relations and Communications. I'll begin by walking through the agenda for today's presentation. I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, we will open for questions. I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risks and uncertainties, and actual results may differ materially. First and foremost, I'm pleased to welcome Dr. Helen Tayton-Martin as the new CEO of Evaxion effective November 24. So Dr. Tayton-Martin brings extensive biotech leadership, fundraising and partnership experience. Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. Helen holds a PhD in molecular immunology and MBA and with more than 30 years of experience in early research through project approval, Helen is an ideal candidate to lead the next stages of Evaxion strategy. This also means that I will return to my previous role as CSO and with Helen's transition from Director in the Board to CEO, Jens Bitsch will join the Board as an adviser and observer with the intention to seek election at the next AGM. Since the last business update, we have made several significant achievements. Historical in-licensing of EVX-B3 by MSD, providing significant cash and validation. The extension evaluation period or the evaluation period for EVX-B2 has been extended. We have several ongoing partnership discussions, though market uncertainty affects deal climate. We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia to our pipeline. Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. Lastly, we have strengthened our financial position, and we now have a cash runway extended to second half of 2027. And this is based on a USD 7.5 million option exercise fee received from MSD and an additional capital market funding sources, and Thomas will share detail around this. So, as mentioned, one of the main highlights of the quarter is the MSD transformative deal. So, in September 25, was a historical moment for a vaccine with MSD or Merck exercising their option on EVX-B3. So this was the first ever in-licensing of an AI discovered vaccine candidate by a major pharma company. And as mentioned, the $7.5 million exercise fee extends our cash runway significantly. The deal confirms our strategy of value creation through partnerships even with industry giants like MSD. It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. And not related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. So 2025 is shaping up to be a pivotal year for Evaxion. We've achieved several key milestones since the last business update. As mentioned, MSD exercised the option on EVX-B3. We presented two-year clinical outcome data from our EVX-01 Phase II study, and we have announced the addition of EVX-04 to our pipeline and EVX-04 is the lead candidate for our precision cancer vaccine. And looking ahead, we are expecting to provide further R&D and business development updates. So let's shift focus to our recent R&D and AI-Immunology progress. EVX-04 is our novel AI designed cancer vaccine candidate targeting nonconventional antigens from the dark genome, so-called endogenous retrovirus or ERVs. And these ERVs are specifically expressed in cancers of dormant in normal tissue, making them an attractive target for cancer vaccines. EVX-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia, where we know relapses remain a major challenge. The vaccine is based on our AI-Immunology platform, leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that matches the expression profile and also the immune characteristics in patients. And we have now designed the lead candidate and have conducted preclinical studies. Next steps include GMP manufacturing and additional IND-enabling studies to prepare for a first-in-human study. With the EVX-01 lead vaccine candidate selected, the program has been added to our pipeline. Further changes include the removal of the EVX-02 program as we do not have any active development currently ongoing on this program. The EVX-02 vaccine program serves as proof-of-concept for DNA delivery of neoantigen and has informed on the design of both EVX-03 and 04. Our lead program, EVX-01, a personalized cancer vaccine that includes multiple patient-specific targets, so-called neoantigens that we identify with our AI-Immunology platform from patient tumor material. EVX-01 is administered in combination with pembrolizumab, an immune checkpoint inhibitor to enhance the clinical efficacy. So, in October, we presented two-year clinical outcome data from our Phase II trial in an oral session at the ESMO Congress. And the results are highly encouraging and were received well by the scientific and medical community. So, at the congress, we reported a 75% objective overall response. We also saw that 11 out of 12 patients that responded had a sustained response at two years mark. We also saw a 34% conversion rate, meaning that patients with stable disease or a partial response deepened their response upon EVX-01 treatment. So we find the clinical outcome data very encouraging. And further, we believe that they compare favorably to historical pembro monotherapy data. Equally encouraging is the strong immunological activity of EVX-01, which is critical for long-term efficacy. So, in all patients treated with EVX-01, we saw a neoantigen-specific T cell response. Further, when assessing the individual neoantigen immune responses, we demonstrated that 81% of the vaccine neoantigens administered across patients were immunogenic. So this high hit rate provides strong evidence of the predictive power of our AI-Immunology platform. We also showed that the immune responses were sustained throughout the two-year trial period. Even after dosing after the dosing period ended, T cell activity remained high, indicating lasting immune memory. And durable T cell responses are essential for preventing relapses and in achieving long-term control of melanoma. So this reinforces the potential of EVX-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with standard of care, but also builds on a robust immune defense. As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development time lines. It enables us to optimize vaccine candidates with high precision, both for new and approved vaccines. So, from data input to candidate generation, the process is now fully automated, ensuring optimal sequence and confirmation of vaccine targets. And as mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. And further, it seamlessly connects with downstream processes supporting a smooth transition from design to production. And the design module has already been applied in some of our key R&D projects. One first example is the use of the module to identify and select regions of an antigen that can be expressed. So we noticed that the full length of a particular antigen could not be expressed due to solubility constraints. But when we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen. Another example is of the application is that we can, with the module, predict most optimal sequences of a vaccine target based on a given antigen protein structure. And here, we have also been able to rescue a HER2 express protein that would require labor-intensive and trial and error design approaches to find expressible constructs. So with this new design module, it position us at the forefront of AI-driven vaccine innovation and further enable us to move fast from target discovery to final product candidate. So, in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. And we look forward to updating you as our programs continue to advance. So, with that, I would like to give the word to Thomas to present the financial results.

Yes. Thank you, Birgitte. I am happy to present the financial results for the quarter. And maybe let me just start with an overview of the achievements that we have done throughout the year up until now based on strong execution of our financial strategy. As we can see here on the slide also, throughout the year, we have made a number of activities with capital market activities with, of course, also the agreement that we did with the European Investment Bank of debt conversion plus also MSD out-licensing of the EVX-B3. So throughout the year and up until end of October, we have activities in the -- to the sound of USD 31.8 million, all which basically helps strengthening our equity and certainly also our runway, which is now extended into the second half of 2027. So really a good and strong achievement and following the financial strategy that we have laid out. If we zoom in on the third quarter and the highlights from the third quarter, we certainly have had a strong financial quarterly performance. As mentioned, the cash runway now has been extended into the second half of 2027. And we've also seen in the quarter the option exercised by Merck or MSD, which not only provides cash income now, but also has a future revenue income of potentially up to $592 million. We are well on track also in the third quarter on delivering on our financial targets for the full year. And throughout the quarter, we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income. So really a good and strong quarter. If we look a little bit closer on the profit and loss element of it, clearly, the revenue from MSD drives the first -- drives the quarterly operational gain, the first of its kind for action -- but also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter. So also from earlier communications, we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level. Net financials in the quarter is to the sound of $1.3 million, driven by the debt conversion that we did in July. The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10. That premium has been recorded on the financial income for the quarter. And that then brings the income for the quarter to the USD 4.6 million. Turning to the balance sheet. We certainly, as mentioned already, have continued the strong execution that also has improved our equity. The equity now stands at the end of the quarter at USD 16.6 million. Included in the equity is a derivative liability with a net impact of $1.5 million. The derivative stems from our public offering in January and the investor warrants that we had from that date. However, in October, we have seen, as mentioned already, warrant exercises of $2.7 million, which means that this net impact of the derivative will be at a minimal value at the end of the year. So also a good outcome. It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrants of 2.8 million. Also important to note is that our cash balance end of June is at a sound and solid USD 10.6 million and we'll see further cash income as we -- or cash flow in as we received in October, the revenue income from MSD and also the cash from the sales of shares due to the investor warrant exercise. And last but not least, the debt conversion -- debt to equity conversion with the European Investment Bank really has strengthened our balance sheet, has improved our cash flow as we move forward and has certainly also lowered our leverage. So really a great outcome from that event also. So a good solid quarter following along our financial strategy. And with that, I then hand it back to Birgitte.

Thank you, Thomas. So lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority and multiple parallel partnership discussions are currently ongoing. Cash runway is extended to second half of 2027. And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. Please follow the operator's instructions. Thank you.

[Operator Instructions] First question comes from Soumit Roy at JonesTrading.

Congratulations on all the progress this quarter. A quick question on the EVX-01. What are -- if you can give us any color on the potential partnership deal, like what seems -- what is the key question that you're getting from a partner, they want to wait for a much longer-term data or any other key achievements you have to present for a successful deal?

Yes. Thank you for that question. So we just presented, as mentioned, the two-year clinical outcome data. And I would say that we have moved from questions around quality of data, how does your platform work to more how can we apply your technology within perhaps other types of cancer indications. So the data was received well, and we have been discussing it with key opinion leaders. We have also been discussing it with potential partners. And the strategy is that we will out-license it at the current development stage and then the partner can, of course, decide on potential next step. If we continue on the track we are currently with advanced melanoma, the next most likely step would be to conduct a larger randomized control arm study comparing the combination of EVX-01 plus standard of care to standard of care alone. So that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden, meaning that we can select high-quality neoantigens and formulate a vaccine that would benefit the patients. So multiple different discussions are ongoing and also different questions are coming our way. But generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward together and find solutions for manufacturing and also for other indications.

Got it. One last question. Congrats on unveiling the EVX-04 in the AML program. If you can give us a slight understanding on the target or how is it -- is it expressed on AML stem cells, like CD33, CD123 have been tried and trying to understand what is the differentiation from this target.

Yes. No, this is a very good question. So the way that we have applied our AI-Immunology platform is that we look at genomic and transcriptomic data. And for this particular type of antigens, we mainly look at transcriptomic data. So the sequences that are being expressed as messenger RNA or RNA in general in the tumors. And then we have looked -- we started out by actually analyzing several different types of novel classes of antigens. And we realized that in certain indications and AML is one of them, there's a very high expression level of these endogenous retroviral sequences from the dark genome, meaning that we can across patients, find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine. So this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients. But we're still using AI-Immunology and our core technology to identify the most optimal antigens. Now it's just coming from the dark genome.

The next question comes from Nelson Cox at Lake Street Capital.

Nelson on for Thomas. Congrats on all the progress here this quarter. I'll maybe ask my two upfront, and apologies if I've kind of missed some of this, I had some technical issues. But a lot of updates here as of late. Maybe at a high level, can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? And then when you look at the proportion of your business development conversations you're having today, can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline?

Thomas, thank you for that question. So we do have multiple dialogues ongoing. And I would say that they are across -- the interest is across our R&D pipeline, but also centered around our capabilities for identifying novel targets, so classical target discovery programs. There's interest in our oncology programs, and there's also interest in our infectious disease programs. So it's a little bit mixed, I would say, and some companies do have preferences in infectious disease. Some do have interest in both vaccine candidates that we have developed and in target discovery collaborations. So a little bit of mix and that confirms, I would say, our strategy to monetize on both our own in-house developed vaccine candidates, but also to enter into or target discovery collaborations. I cannot comment so much on exactly where we are as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal. But a lot of activities, and we can see that the interest is increasing when we have major data readouts as we have had in this last quarter with the EVX-01 Phase II data coming out.

[Operator Instructions] The next question comes from Swayampakula Ramakanth at H.C. Wainwright.

This is RK from H.C. Wainwright. So, certainly, there are very interesting developments going on at the company. So can we focus for a second on your automated design module, which is yet another interesting AI design -- drug design module that you have. So how should we think about this? Is this something that can help your internal designing -- I mean, designing of your internal molecules only? Or is this up for entering into partnerships? Or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules. It looks like there's a lot of places where this thing could go. And what are your thoughts on that?

Yes, you're absolutely right. It can go in multiple directions. So, in the past, we have used AI immunology to identify novel vaccine targets. And then these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. And this process has been labor intensive. So the ambition was to set up an automated process for this. And we have now been able to launch a new module where several different AI tools are being integrating, enabling us to go from target discovery to product candidate selection very fast. So that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or in general, key targets that these antigens or targets can also be produced in a cost-effective way. So I do see multiple options for monetizing on this new module.

Okay. So, and then coming into the real world and talk about EVX-01 for more -- for another minute. At SITC, you're planning to present some additional data from the ongoing trial. What sort of data would come out from there? And how would it strengthen your narrative on EVX-01, not only for yourselves, but also for a potential partner, whether it is just on the drug or on the platform, just as you were talking about with -- when you're answering Soumit Roy?

So at ESMO, we presented the clinical outcome data, and we are still in the process of analyzing patient samples. So -- we have collected samples, blood samples before therapy during vaccination and then also as follow-up samples. And all of these samples from the patients are currently being assessed in our own labs. So, we do, of course, monitoring of the EVX-01 induced T cell responses, but we also do deeper phenotypic analysis. So some of this will go out at SITC. We have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients. So more to come, more deep dive into the immune profiles of the cells. collected from the patients. And then we also have the extension phase of the EVX-01 trial where six patients are now receiving EVX-01 as a monotherapy. So more data will come from this subset of patients.

Perfect. And then my last question is on the MSD relationship. And it's great to have the $7.5 million. But how much more -- do you still need to give any additional data for the second molecule? Or is it the Merck still has to complete their due diligence on that -- on the data that you've given them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million?

Yes. So, for EVX-B2, MSD is currently evaluating the data that we have provided and further, they are in the process of generating some confirmatory analysis. And that was also why the evaluation term was extended. So we expect that they will come back with an answer in the -- or in the first half of next year. But the process is ongoing, and it's, of course, very exciting, and we would love to out-license EVX-B2 to MSD.

There are no further questions. So I shall hand back to you for final remarks.

Yes. And thank you for joining us today. And please do not hesitate to reach out should you have any additional questions. Thank you.

That concludes today's presentation. Thank you for participating. You may now disconnect. Speakers, please stand by.

Hello, and welcome to Evaxion's Second Quarter 2025 Conference Call. [Operator Instructions] I would now like to turn the conference over to Birgitte Rono, Interim CEO and CSO. You may begin.

Thank you for that. So first and foremost, welcome to our Q2 2025 business update and financial results. I am Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. And with me today, I have Thomas Schmidt, Chief Financial Officer, now permanent CFO as of August 1; and Mads Kronborg, VP of IR and Communications. Today, I will start with a short introduction, followed by an R&D update, and then Thomas will present our Q2 financial results. And lastly, we are, of course, as always, open for questions. So before we begin, please note that today's presentation contains forward-looking statements based on current expectations and actual results may differ from this. So since last quarter, we have made significant achievements and with the partnership with MSD, we are on track towards potential option exercise in the second half of 2025. Our business development pipeline remains solid and supports the FY target. However, we do see that the challenging financial markets and increased regulatory uncertainty is impacting deal execution in general. Key R&D events and progress include EVX-01 2-year clinical efficacy data accepted for an oral presentation at the ESMO Congress in 2025 and treatment in the main part of the EVX-01 Phase II trial is completed and patients have been recruited for the 1-year extension phase. We have also expanded our R&D pipeline with EVX-B4 and we will get back to the details around this. Further, we have received a grant from the Gates Foundation, allowing for risk and cost-free application of the platform in yet another disease, polio. On the financial side, we have cash at hand until mid-2026 and we have converted our loan from the European Investment Bank to equity with an immediate increase in equity with USD 4.1 million. Since last quarter, we have achieved an additional milestone with the initiation of the EVX-B4 program and we are well on track with the many exciting milestones coming up in the second half of '25. If we take a closer look at our R&D pipeline and recent progress, we have a very broad R&D pipeline of AI-Immunology designed vaccine candidates, spanning across 2 key disease areas, cancer and infectious diseases. And today, I'll walk you through some of our latest progress in key R&D programs. I'll start with our lead asset, EVX-01, or personalized peptide-based cancer vaccine currently in Phase II clinical development. And then I would also, as mentioned before, point your attention to our recently added pipeline program, EVX-B4, a discovery program with the objective of developing a preventive vaccine against Group A Streptococcus. And lastly, I'll present our progress in our [ CB ] program that is EVX-V1. So back to EVX-01. EVX-01 is, as mentioned, currently in Phase II and is being developed as a first-line treatment for advanced melanoma. As I mentioned earlier, our upcoming 2-year data from the EVX-01 Phase II trial will be presented at the European Society for Medical Oncology, also called ESMO Congress in October. And the ESMO Congress is one of the most important and prestigious medical oncology congresses in the world. And we are very much looking forward to this as it gives us a great opportunity to interact with the global audience, including potential partners. And to this end, we are currently finalizing the 2-year clinical outcome data for preparing it for the ESMO presentation and partner discussions. And as we talked about earlier, we have extended the EVX-01 Phase II study, allowing us to obtain 3-year clinical outcome data. During this extension phase, EVX-01 will be administered as a monotherapy, allowing us better to understand the vaccine's stand-alone effect. The extension involves minimal additional costs as clinical trials remain active and vaccine production is already complete. Furthermore, we are planning to seek advice from FDA around the path to registration for this compound as we believe that this is important for any potential partners to understand this path. The strategy for the assets remain unchanged, and we are actively seeking partners that can take the compound through the last steps of clinical development towards registration. Yes. Another key recent achievement is the grant we received from the Gates Foundation. And in this collaboration, we are applying AI-Immunology to design a subunit vaccine against polio, and the project is progressing according to plan and in close dialogue with the Gates Foundation and the Polio Program Officer. So this initial grant could potentially lead to further projects and plans with the Gates Foundation or any other partner. As we saw that the announcement of the grant gave or generated significant attention to our platform and pipeline. Further, we are making strong progress in our infectious disease vaccine pipeline. And as mentioned, in June, we announced the expansion of the infectious disease R&D pipeline with the addition of the EVX-B4 program. And this program aims at developing a preventive vaccine against Group A Streptococcus, also called GAS. And development and testing of potential GAS vaccine has been traced back to 1923, yet no vaccine exists today. So we have conducted initial computational analysis demonstrated that AI- Immunology can identify novel vaccine targets to combat the pathogen. We have ongoing and future planned activities that include identification and testing of novel antigens for immunogenicity, functionality and protection in mouse models and in vitro assays. So GAS infections can cause a broad spectrum of health issues, including severe invasive infections and also the development of immune-mediated life-threatening conditions. There is an increase in antibiotic resistance and therefore a great need for finding novel treatment solutions. And with EVX-B4, we are hopefully able to offer such a solution. Lastly, I will briefly touch on our EVX-V1 program. And in this program, we are developing a multicomponent vaccine for the prevention of CMV infections. We are in early preclinical development heading towards lead antigen selection in the second half of 2025. We believe that an efficacious vaccine should contain both a B and T cell antigens and also glycoproteins that are known to be essential for viral entry. Despite many years of focus, no vaccine is approved for CMV, but with AI-Immunology, we believe that we can develop an efficacious vaccine that targets the virus from multiple angles. This multi-target approach stands out from traditional methods that have been focused on a limited set of glycoproteins involved in viral entry. Combating the virus from numerous angles is expected to enhance the efficacy of future vaccines. And with our proprietary platform, AI-Immunology, we are uniquely positioned to optimize already no antigens and further to identify novel B and T cell targets. And to give an initial insight into the data in this program, we have designed a proprietary glycoprotein B antigen, and that is one of the glycoproteins essential for viral entry that demonstrates superior ability to neutralize the virus. Further, we are currently pursuing top ranked B-cell antigens identified with AI-Immunology and initial data demonstrate induction of the potent tumor or antibody immune response in immunized animals. Several T cell epitope vaccine designs targeting multiple genes in the viral life cycle have been completed and they all induce a strong cellular immune response. So in summary, we do see significant progress across our pipeline in both our Oncology and Infectious Disease programs and we are well on track for our next milestones. And we look forward to updating you as our programs continue to advance. So with that, I will give the word to Thomas to present the financial results.

Yes. Thank you, Birgitte. And I will now, of course, go through the financial highlights, but we'll start, first and foremost, with a summary of the agreement that we have made with the European Investment Bank that really fundamentally helps our capital structure. So on July 11, we finalized the debt settlement agreement with the European Investment Bank where they converted EUR 3.5 million of the total EUR 7 million loan, and that was converted into equity via a purchase of ordinary Evaxion shares. Our Evaxion shares and the purchase price was $4.87 per ADS, representing 89% premium versus the closing stock exchange on July 11. That immediately also in July then increased our equity by $4.1 million and also then, of course, both simplified our balance sheet and certainly reduced our overall liabilities. Furthermore, and also looking forward, it improves our cash flow and certainly also the repayment of course that we need to do at the end of the loan agreement in 2028. So all in all, a very good agreement that we have reached with the European Investment Bank. And as mentioned, as the agreement was done in July, it is, of course, not included in our Q2 financials but will eventually be once we get into Q3. Q2 financial highlights. First and foremost, our cash position is, at the end of June, $14.7 million. And with an operating cash burn that we still expect to be around $14 million. That also means we have cash in hand to fund operations until mid 2026. And important to note, that takes us past the potential option exercise by the MSD and also passed our 2-year data readout on our EVX-01 study. Our overall spend was reduced in Q2 2025 compared to same period last year, which mainly reflects project timing. We still expect for the full year to be at a similar level versus last year from a spending perspective also. Total equity end of June of $6.2 million obviously strengthened compared to end of last year due to the capital market activities we've done in the first half of the year. And again, this will further be strengthened in July as we -- the agreement registered with the European Investment Bank. Our Q2 profit and loss statement shows an operating loss of $4.3 million, which again compares to $4.6 million in the same period last year. R&D project costs are expected to increase in the second half year, so in the 2 coming quarters, while we still expect operating expenses in line with 2024. This also means that we expect, as mentioned already, the operational cash burn of approximately $14 million for the full year 2025. Our net financial expenses of $0.7 million in the Q2 compared to $1.8 million net financial expenses in Q2 last year and in both years driven by reassessment of our derivative liability. Important to note is that the derivative liability in 2024 came from the February public offering in 2024, while this year, it comes from our January public offering. So 2 independent and different derivative liability. Our net loss for the quarter of $4.8 million compared to a net loss of $6.2 million same period last year. And the main difference is exactly the difference in net financial expenses. So that's the driver behind that difference. Turning to the balance sheet. Our equity of USD 6.2 million, certainly further will be strengthened in July or has been strengthened in July as we have booked the conversion into equity from the EIB. The derivative liability from the public offering, as mentioned in January 2025, net impacts our equity of USD 0.4 million as of end of June. Cash at hand was $14.7 million. And again, really important to notice a note that this gives us a cash runway until mid-2026. So both past our potential MSD option exercise and past our EVX-01 2-year data. But also importantly, the cash runway projection into mid-2026 does not yet include the potential MSD expertise or any new business development deals. So both will net case further extend our cash runway. And with that, I hand it back to Birgitte for some closing remarks.

Thank you, Thomas. So lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum, and we are tracking towards several potential value catalysts. Business development remains a key priority and multiple parallel partnership discussions are currently ongoing. And as Thomas mentioned, we have cash at the hand until this 2026. And that takes us, as Thomas also explains beyond the EVX-01 2-year data and the potential MSD option exercise. And with that, I would like to thank you for your time and your attention, and we'll be happy to answer any questions.

[Operator Instructions] Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets.

Birgitte, I was curious if you could maybe detail for us what remaining steps are there in the process for Merck to make a decision on whether or not they want to option either or both of the programs.

Yes. Thank you for that question. So we have been running one of the collaborations, the B3 since September 2023. So we entered into this R&D collaboration. And there's been a lot of very exciting data generated under this collaboration. And we are currently -- according to the plan time lines are kept, and we are heading towards the conclusion here in the second half of 2025. For B2, this is more a type of, I would say, evaluation collaboration. So MSD have been looking into our data and been conducting some studies on their side. Again, we are on track in terms of time lines and also, yes, heading towards this conclusion in the second half of 2025. So all in all, it looks very promising, and we are progressing according to the plan.

Got it. I appreciate that. And then one final question. If you look at the business development conversations you're having, are they primarily on the Infectious Disease side? Is there some Oncology interest? Can you maybe just give us a sense of what those discussions look like?

Yes. No. It's across the R&D pipeline and assets across the 2 therapy areas and also centered around what we call target discovery collaboration, so where we apply AI-Immunology and find novel targets for a certain pathogen. So it's a mixed picture at the moment, but definitely dialogues across some are more mature than others. And I think that's just the name of the game. And it's, of course -- I know there's a lot of curiosity around this. But as you know, we cannot say a lot about this until there is a signed contract. So -- but we remain optimistic and do see also new dialogues starting.

Our next question comes from the line of [ Charles Wallace ] at H.C. Wainright.

This is Charles on for RK. I had a question about the data at ESMO coming up. So how will the 2-year data, like the clinical outcomes compared to the 1-year data that was presented, and how many of the patients from year 1 will be seen in the 2-year data? And then also, with the extension to the third year, how many patients will you enroll additionally?

Yes. Charles, thank you for those questions. So we have not yet disclosed the 2-year data for EVX-01. So you have to be a bit patient here. We have, of course, since our last update of the clinical data, the 1-year data gathered additional information and scans, et cetera, of all the patients. We still have 18 -- no, sorry, 11 patients active in the trial. So a lot of the patients are faring extremely well. So more to come on this. For the extension phase, it's a subset of the patients that now have consented to participate in this additional year. They will receive 2 doses of EVX-01 and without concomitant pembrolizumab treatment. So this allows us to look further into the mode of action of EVX-01 without having this background of the checkpoint inhibitor. We have not yet said a lot about how many patients, et cetera, because there's still -- yes, we will come back with more information on this.

[Operator Instructions] I'm showing no further questions in the queue. I would now like to turn the call back over to Birgitte for closing remarks.

Thank you for that. So finally, I would just like to say thank you for all of you participating in this business update and financial results. And we are, of course, as always, looking forward to update you on the further progress. Thank you.

Thank you.

Ladies and gentlemen, that concludes today's conference call. You may now disconnect.