Q4 2025 Evaxion Biotech AS Earnings Call

March 6, 2026

Operator: Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Full Year 2025 Financial Results Webcast and Conference Call. At this time, all participants are in a listen only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one again. Please be advised that today's conference is being recorded. Very sorry. I will now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please go ahead.

Helen Tayton-Martin: Thank you, good morning, everyone. Thank you for joining us for Evaxion business update following the reporting of our 2025 full year financial results yesterday. Apologies that this call is 24 hours later than we anti-anticipated, but for technical reasons, we're 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 CEO. If we move to the first slide. 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 Rønø, will walk through our key R&D updates from the year, including the latest innovations from our AI-Immunology platform. Our CFO, Thomas Schmidt, will walk through our 2025 financial results before we close with a few concluding remarks and take questions.

Helen Tayton-Martin: Moving to the next slide. Of course, our comments and presentation today may contain forward-looking statements. All participants on today's call are referred to our filed SEC statements and specifically our most recent 20th annual report for 2025, filed yesterday. 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 core pillars of the company. First of all, in business development, we were delighted with the progress in our collaboration with MSD in our infectious disease portfolio, with the decision by Merck to exercise its option over our EVX-B3 program candidate.

Helen Tayton-Martin: 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 through an AI discovery platform. 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 two-year phase 2 data at ESMO on our EVX-01 program with a personalized neoantigen-directed cancer vaccine in advanced melanoma patients.

Helen Tayton-Martin: We also presented preclinical data at ASH on our first cancer vaccine to a shared antigen-based directed to a conserved endogenous retroviral or ERV element 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 Streptococcus. On the platform itself, the team has continued to innovate and use the platform to not only identify optimal vaccine candidates, but improve their design biology for product delivery for us in our new automated module. 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.

Helen Tayton-Martin: Finally, we were very pleased to see the capital influx to the business last year through financing, business development, and the use of our ATM, which now gives Evaxion a cash runway to the second half of 2027. Thomas will talk more to this later. Moving to the next slide. Just as a reminder, Evaxion has built a broad novel product focused pipeline of assets from its unique AI-Immunology platform, clinically validated with the cancer vaccine space with our EVX-01 peptide-based vaccine in advanced melanoma. Supported by assets and data on DNA and RNA platforms, and together with a preclinical pipeline of infectious disease vaccine candidates focused on challenging targets remaining intractable with conventional approaches and subject to significant medical need. Onto the next slide.

Helen Tayton-Martin: 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 affect over 14 million patients annually in the US. 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'll be more to come on this later in the year. Finally, on the next slide, turning to our 2026 milestones.

Helen Tayton-Martin: This year, we will be updating on our EVX-01 program with additional biomarker and immunogenicity data at AACR, and then the clinical data, 3-year data later towards the end of the year. 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 A Streptococcus in the second half of the year. Finally, be ready to submit our regulatory application for our next EVX-04 candidate vaccine candidate for the shared ErbB antigens in AML by the end of the year. Throughout, we remain committed to deriving value from both our platform and our pipeline assets through partnerships for our shareholders and patients. I'll now hand over to Birgitte to update you further on our R&D achievements.

Birgitte Rønø: Thank you, Helen. 2025 marked a turning point with significant advancement across our R&D pipeline and also, and our AI platform. Additionally, as Helen alluded to, we also entered into the in-licensing agreement with MSD on the EVX-B3 program. Our 2025 focus has been on strengthening our platform's predictive power, maturing key R&D assets, and on building the foundation for future partnerships. The 2025 achievements position us well as we move towards the data-rich milestones in 2026 that Helen just presented. With that, I'll begin by walking through individual key programs and platform development. Next slide, please. EVX-01, our personalized peptide-based cancer vaccine in advanced melanomas, continues to deliver strong clinical data.

Birgitte Rønø: Our two-year phase two data presented at an oral session at ESMO in October showed strong clinical outcome, including a high objective response rate of 75% and complete response rate of 25%. Notably, 92% of the responders remained in response at this two-year mark. Key biomarker data included the very high immunogenicity hit rate with 20 or 81% of all the individual new antigen administered across patients, giving rise to a specific T-cell response. This very impressive hit rate outcompetes data from similar programs conducted by others. This truly underlines the precision of our AI-Immunology platform to identify relevant vaccine targets. Two key milestones are expected for this program, as Helen also alluded to. Additional biomarker and immunogenicity data expected in the first half of 2026.

Birgitte Rønø: We also plan to communicate the 3-year data from a subset of patients that are currently in an expansion part of the phase II study, and that will be reported in the second half of 2026. Importantly, we aim to conduct future trials in partnership, ensuring the broadest possible impacts for patients. Moving to the next slide, and EVX-04, our off-the-shelf therapeutic vaccine for Acute Myeloid Leukemia or AML. We have generated a compelling preclinical 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, importantly, we aim to conduct future trials in partnership and ensure the broadest possible impacts for patients.

So, moving to the next slide and Elixir for our official therapeutic vaccines for acute myeloid leukemia, or AML. We have generated compelling preclinical evidence supporting its development.

In this program, we are focusing on a completely novel class of tumor antigens, so-called indigenous special viruses, or Earths.

Birgitte Rønø: With AI-Immunology, we have identified millions of short ERV fragments from patient sequencing tumor data and designed the EVX-04 vaccines with 16 optimal ERV antigen fragments selected based on cross-patient relevance and also on their immunological potential. Key data include in vitro vaccination studies demonstrating that all of these 16 ERV fragments in the vaccine induce a strong specific immune response and further that EVX-04 prevents tumor growth in several mouse tumor models and induces strong T-cell responses. 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 readiness for EVX-04, we have completed key steps including antigen selection and lead development.

These are selectively and highly expressed in AML blasts, making them attractive as therapeutic ties.

So, with AI monology, we have identified millions of short Earth fragments from patient sequencing tumor data, and assigned the EVX for four vaccines, uh, with 16 optimum Earth antigen fragments selected, based on cross-patient balance and also on their immunological potential.

So key data include, uh, individual vaccination studies, uh, demonstrating that all of these 16 Earth fragments in the vaccine induced a strong, specific immune response and further that EVXO 4 preventable.

So, again, these findings reinforce the power of our platform, and here, we have expanded it to uncover unique tumor antigens that are not accessible through traditional discovery methods.

Birgitte Rønø: We have conducted preclinical efficacy studies and are currently conducting 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 2026, which enable first-in-human testing. This program is a prime example of how AI-Immunology accelerates vaccine design from concept through clinic. Next slide, please. Now turning to our key infectious disease programs. 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 Neisseria gonorrhoeae. Our preclinical data package is strong and comprehensive, demonstrating significant protection in a mouse infectious model.

Next slide, please. As we progress towards clinical readiness, for events of all, we have, uh, completed key steps, including antigen selection and lead development. We have conducted pre-preclinical efficacy studies and are currently conducting 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 through clinic.

So, next slide, please. Now, turning to our key indexes, disease programs,

So, after we, uh, retained the full global rights to Edex B2, uh, late last year, we are now fully in control of the development of this highly differentiated vaccine candidate targeting Nigeria.

Birgitte Rønø: We have demonstrated broad efficacy against 50 clinically relevant isolates reflecting coverage across diverse strains and further induction of significant humoral and cellular responses in mice. We have also demonstrated a well-established mechanism of action supported by potent antibody-dependent complement-mediated killing. 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. Given the strength of our data, we see a clear opportunity to engage with potential partners to progress the program towards clinical development. Next slide, please. Another of our key infectious disease vaccine programs is EVX-B1. In this program, we are developing a multi-target vaccine against cytomegalovirus, or CMV.

So our preclinical data package is strong and comprehensive, demonstrating significant protection in a mouse intestis model. We have demonstrated broad efficacy against 50 clinically relevant.

Isolates reflecting coverage across diverse strengths.

And further induction of significant human and cellular responses in mice. And we have also, uh, demonstrated a well-established mechanism of action supported by potent antibody-dependent complement-mediated killing.

So collectively, these, uh, results—Precision, EVX, B2 S1—are the most advanced and differentiated infectious disease preclinical, uh, 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.

Birgitte Rønø: Instead of relying on a single glycoprotein or limited set of glycoproteins, the program integrates both these well-described glycoproteins and novel antigens to target the virus from multiple complementary angles. This broad multi-component strategy is designed to enhance vaccine efficacy and also to reduce the risk of viral escape. We have applied AI-Immunology for both antigen optimization of the known glycoproteins and for identification of truly novel antigens. First, we improved these established CMV antigens that are essential for virus neutralization. As part of this, we have engineered the glycoprotein B antigen by locking it in a prefusion state. This AI-Immunology designed construct has demonstrated a superior neutralization capacity compared to the native protein.

Target vaccine against such Migos virus or CMD.

And instead of the line on a single glycoprotein, or limited set of glycoproteins, the program integrates both, uh, these well described. Um,

Glyphosate novel. Antigens to target the virus from multiple complementary angles.

And so, this broad multicomponent strategy is designed to

Enhance vaccine efficacy and, also, to reduce the risk of viral escape.

So, we have applied AI analogy for both antigen optimization of the known glylo proteins, and for identification of truly novel antigens.

so first we

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 it in a prefusion state.

Birgitte Rønø: Secondly, we are identifying and validating entirely novel antigens. Several of these have already demonstrated the ability to inhibit viral entry, and further, we are characterizing them at the moment. Supported by this strong preclinical data, EVX-B1 represent a highly promising program for continued development and for future partnership discussions. Next slide, please. Now turning to the recent development of our AI-Immunology platform. AI, our AI-Immunology platform continues to expand in capability. The platform integrates multi-omic data set to generate ranked antigen lists within 24 hours. In October last year, we launched an automated vaccine design module enabling sequence and structural optimization directly from the shortlisted antigens. This end-to-end automation significantly reduce cost, development time, and also risk. Next slide, please.

And this AI Immunology-designed construct has demonstrated a superior neutralization capacity compared to the native protein.

The second thing, we are identifying and validating entirely novel antigens, and several of these...

They have already demonstrated the ability to inhibit viral entry, and further, we are characterizing them.

At the moment.

So, supported by this strong preclinical data, V1 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,

Um, so AI, our AI Immunology platform continues to expand in, uh, capabilities. So the platform integrates multi-omic data sets to generate ranked antigen lists, within 24 hours. So in October, last year, we launched an automated vaccine design module enabling a sequence and structural optimization directly from this shortlisted, uh, antigens.

And this, in the end, automation significantly reduces cost, uh, development time, and also risk.

Birgitte Rønø: More specifically, the automated module enhances a design of soluble antigen constructs, enabling higher expression, better formulation, and improved manufacturability. This capability directs the design of soluble antigen constructs and also solubilizing antigens using inverse folding, producing more reliable antigen constructs than the wild type variants. The result is a faster and more cost-effective design cycle, fully integrated into our antigen discovery and vaccine optimization workflow. This strengthens the foundation for all of our programs across oncology and infectious diseases. In conclusion, we have seen strong progress across our platform and our R&D pipeline, and we are encouraged by the momentum. We look forward to keeping you updated as we advance through 2026. With that, I will now hand over to Thomas, who will walk us through our financial results.

So, next slide, please. So, more specifically, the automated module enhances, uh, the design of soluble antigen constructs, enabling higher expression, better formulation, and improved manufacturability.

So this capability, uh, directs the design of soluble antigen sub, uh, constructs and also, uh, solubilizing antigens using inverse folding, producing more reliable antigen constructs than—

The white side variance.

The result is a faster and more cost-effective design cycle, fully integrated into our antigen discovery and the vaccine optimization workflow.

So, this strengthens the foundation for all of our programs across oncology and infectious diseases.

So in conclusion, uh, 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 advance.

2 2026.

Thomas Schmidt: Yes. Thank you, Birgitte. Also warm welcome from my side to our call today. I will now walk you through the financial results for 2025. 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 use in September. Furthermore, the exercise of investor warrants from our January offering in October and November, all summing up to a cash inflow of $32 million.

And with that, I will now hand over to Thomas, who will walk us through Power Financial Wizards.

Yes, thank you for giving it. Um, and, uh, also a warm welcome from my side to our call today. Um, and I will now walk you through the financial results for 2025. So, turning to the next page. Uh, we have throughout 2025 been really successful in expanding, um, on our cash runway and also strengthening, uh, on our equity side. This has happened throughout the year, uh, through public offering and the use of ATM we did in January, followed by the NSD exercise fee and the ATM use in September. And furthermore, uh, the exercise of investor warrants from our January offering, uh, in October and November, all, so on.

Thomas Schmidt: Furthermore, as also shown on this slide, our EIB debt to equity conversion done in July of $4.1 million, we've reduced certainly our cash, future cash out, and thereby certainly also expanding and extending our cash runway. Finally, with our filing in December of our prospectus supplement regarding our ATM, it has now created us with further flexibility and options as we move forward with expanding our pipeline and platform also. Really, really underlines the strong execution throughout the year. 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.

Of 32 million us. Um, furthermore as also shown on this slide, um, our eib debt to equity conversion, done, in July of 4.1 million us. We've, uh, reduced certainly, our cash future cash out, uh, and thereby certainly also expanding and extending our cash Runway. And finally, with, uh, our filing in December of our prospectus, uh, prospectus supplement regarding our ATM, uh, it has now created us with, uh, further flexibility and options as we move forward.

Thomas Schmidt: 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. With the improved cash runway and equity, we have created more stability and certainly have also reduced uncertainty. I think that is really, really also a highlight for 2025.

Uh, with expanding our Pipeline and platform also. So really, really, uh, underline the strong execution throughout the year and turning to the next slide. Uh, that also leads into the highlights of 2020, uh, 5 where we really have delivered on all the targets that we set, and we are progressing, uh, towards our aim of becoming as a sustainable self-funding, uh, business, both revenue and costs have a pro have improved. Um, while at the same time, we are continuing to invest in our platform and in our pipeline programs, uh, as just mentioned, uh, uh, on the previous slide activities and execution of the MSD,

Thomas Schmidt: 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, also we've improved on our operational costs. We've actually been successful in lowering 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 MSD option exercise, also important to mention, we also had a grant from the Gates Foundation that also has come in 2025. Apologies.

Filled the EIP depth conversion, our ATM and Capital Market. Activities have not only improved our cash position and Runway. But as also significantly, strengthened our Equity, um, and with the improved cash Runway and Equity Equity, we have created more stability, and certainly have also reduced, uh, on certainty. Uh, so I think that is really, really, also a highlight for 25. And again, uh, with the update of 3 and ATM, uh, we have removed the constraints of baby shelf, uh, and also provides us far better flexibility and options in support of our long term strategic, uh, initiatives. And also the long term, uh, plans we do have, um, next slide

Thomas Schmidt: Net financial position of DKK 4.6 million is driven by a premium that we received from our debt conversion, debt to epi-equity conversion from the EIB. Against that goes remeasurement of a derivative liability as some of our warrants or our warrants from the public offering in January were in a different exchange setting, so USD versus our reporting of DKK. Net loss for the year DKK 7.7 million, certainly a bettering compared to last year. As I said before, also a good step on the way of becoming a self funding and profitable business.

Apologies. Um, net financial position of $0.6 million is driven by a premium that we received from our debt conversion—uh, debt-to-equity conversion from the EIP. Uh, and against that goes remeasurement of the derivative liability, as some of our warrants, or our warrants from the public offering in January were in a different, uh,

Thomas Schmidt: Next slide, on the balance sheet items, we ended the year with a cash position of $23 million with a runway that now is extended into half year 2 of 2027. Certainly also a significant improvement compared to last year. This of course will be used for operations expenses and investing into our platform and pipeline. 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 warrant Exercise has been reducing the outstanding warrants in terms of ADSs by 1 million, which leaves another 2.8 million warrants outstanding. Also an improvement in that and really drives in the right direction.

Uh, exchange, uh, setting. So the USD versus our reporting of DKK net loss, uh, for the year 7.7 million, certainly a bettering compared to, uh, last year. Uh, and as I said before, also a good step on the way of becoming a self-funding and profitable business. Next slide on the, uh, balance sheet items. We ended the year with a cash position of $203 million, uh, with a runway that now is extended into half year 2 of 2027. Certainly also a significant, uh, improvement compared to last year. Um, and this of course will be used for operations, uh, expenses, and investing into our platform and pipeline. Um, we currently have an outstanding—uh, we have a total outstanding, 88.

Thomas Schmidt: 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 2026 and the years beyond. With that, I hand it back to Helen for some final concluding remarks.

S of 8.3 million. When assuming that all shares have been converted into adss. We've also through the investor want exercises, exercise has been reducing the outstanding warrants, uh, in terms of ads is by 1 million, which leaves, uh, another 2.8 million warrants outstanding. So also an improvement, uh, in that, uh, and uh, really drives uh, in the right direction. So in summary from a financial position we have during 2025 established a far better Foundation uh that really uh makes us uh 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, uh, final, uh, conclusion, uh, concluding remarks.

Helen Tayton-Martin: Thanks, Thomas. Just moving to the, 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 through 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 drug 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. We're in a good position to move forward, through 2026. We, with that, I'll hand over to the operator for questions.

Thanks, Thomas, and uh, just moving to the last slide.

In summary, 2025 was a year of strong operational momentum and action, in which we achieved several key milestones.

Hey, it's Rule. We strengthen 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 drug discovery, design, and early development.

With a number of potential partnership discussions ongoing, we are already funded into the second half of 2027, so the financial milestone is achieved in 2025.

So we're in a good position to move forward, uh, through 2026. Um, we, uh, with that, I'll hand over to the operator for questions.

Operator: Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. Our first question today comes from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead.

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

To withdraw your question, please press star 1 and 1 again.

Thomas Flaten: Hi, everybody. Thanks for taking the questions. 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, you know, what you have implemented or are going to implement, you know, any changes to strategy, and any bigger picture notes like that could help us with context of your tenure.

Our first question today comes from the line of Thomas Flatten from Lake Street Capital Markets. Please go ahead.

Hi, everybody. Thanks for taking the questions. 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,

Helen Tayton-Martin: Sure. Thanks. Thanks, Thomas. Thanks for the question. Yep, I joined at the end of November last year, so the last three months have flown by. I already had a strong impression from my prior seat on the Evaxion board. In terms of bigger picture changes, I think the fundamentals of Evaxion remain really strong. In fact, I think they have only got stronger through 2025. The ability to have an AI platform that is built up over many years, many iterations, grounded in data and testing of that data in the lab and ultimately in the clinic, has really strengthened the core offering. I remain really excited about the power of the platform in the oncology space and also in the infectious disease space.

Helen Tayton-Martin: I think we're sort of seeing a lot more traction around what we can do with the platform now from external engagement. I think the fundamental strengths of and core of what Evaxion has to offer is even stronger now than potentially before. 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 a clinical response is meaningful and is becoming recognized as meaningful, certainly in our partnering conversations, et cetera. I think that that is core. Clear observation I had before coming into the company and certainly strengthened by all my observations within it. I'm even more impressed by the team that's in place that can deliver on this.

Helen Tayton-Martin: I think in terms of the overall strategy, what Evaxion does well is that early discovery, that early validation, that deep scientific and informatic embedded expertise. We can certainly bring things forward into early clinical development, late preclinical, early clinical. 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're being very cautious about that. We certainly see strength in the gate in getting interest from external parties around the assets that we've already got and actually the capability of the platform.

And ultimately in the clinic has really strengthened the core offering. So I I remain really excited about the power of the, 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, uh, from external engagement. So I think the the fundamental strengths of uh and core of what sort of action has to uh to offer uh is is even stronger. Now uh than 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 a clinical response is Meaningful and is becoming recognized as meaningful. Certainly, in our partnering conversations, Etc. So I, I think that, that, uh, is is core so clear. Clear observation? I had before coming into the company and certainly strengthened by all my observations with within it, um, and even more impressed by the team that's in place that can deliver on this, I think, in terms of

The overall strategy um what of action does? Well is that early discovery that early validation that that's that deep scientific and informatic embedded expertise um and we can we can certainly bring things forward into early clinical development late. Pretty late pre-clinical early clinical. And I think what we're going through at the moment is, is a process of of really um, optimizing where we see the most value in the near term, both in terms of our oncology assets but also um, within the Infectious dis

These areas, I think we are not positioned to take too much further forward into the clinic. So we're being very cautious about that. Um, but we certainly see strength and getting, um, interest from external parties.

Helen Tayton-Martin: No fundamental change to strategy, but I think a sharpening and a deepening of focus around the assets that will add the most value. I hope that's helpful.

Thomas Flaten: That's. Yeah, no, that's great. Thank you, Helen. Just keying off of your last comment there about taking products into the clinic. You mentioned with EVX-04 or 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 ERVs are a bit new, a bit different, in order to attract partner interest?

Around the assets that we've already got, and actually the capability of the platform. So, no fundamental change to strategy, but I think a sharpening and a deepening of focus around the assets that will have the most value.

I hope that's helpful.

Helen Tayton-Martin: 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 set of candidate antigens in the vaccine. I think we're doing some further validation work, which I think will continue to strengthen it. So the answer, in short, is not necessarily, but clearly the more credible validation data that we can add to the package, the stronger the value proposition, to, you know, an external partner. That's obviously what we're all about is maintaining building the value for as long as we can, to strengthen our position.

Yeah that's great. Thank you Holland and just a keying off of your last comment there about taking products into the clinic. And um, you mentioned with evxo 4 or get this presentation, that you would be looking to submit regulatory. Paperwork, um, is that, is that a product that you think you have to take into phase 1? Given that herbs are a bit bit, new a bit different, uh, in order to to to attract partner interests.

Um, I I think that's a really good question. Um, we are certainly, uh, preparing to take it into the clinic and we believe that we we can do that to to gain some initial uh proof of concept. There's a lot of interest around the, the platform at that particular, um, set of candidate. Uh, antigens in the vaccine. I think we, we're doing some further validation work, which I think will continue to strengthen it. I so the answer in short is not necessarily but but clearly the more credible validating data that we can add to the package, uh, the stronger, the value proposition, um, to, you know, an external partner and that's all

Helen Tayton-Martin: I think we're very confident about what we can do with it, pre-clinically, and potentially clinically.

Michael Okunewitch: That's great. Thank you very much.

Thomas Flaten: That's great. Thank you very much.

Obviously what we're what we're all about is is maintaining the vat, building the value for as long as we we can uh, to strengthen our position. And and I think we will, we're very confident about what we can do with it. Um, pretty quickly. Um, and potentially clinically

Helen Tayton-Martin: Thank you.

That's great. Thank you very much.

Thank you.

Operator: Thank you. Our next question today comes from the line of Michael Okunewitch from Maxim Group. Please go ahead.

Thank you.

Our next question today.

Comes from the line of Michael Okanovich, from Maxine Group. Please, go ahead.

Michael Okunewitch: Hi there. Thank you so much for taking my questions today. Congrats on all the great progress you've made.

Helen Tayton-Martin: Thank you.

Michael Okunewitch: 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 yourself would be particularly important for us to watch for from the upcoming data releases, whether that's the three-year data or the biomarker immunogenicity. Is there anything in particular you think is key for driving these partnering discussions?

I guess to start off, I'd just like to see if you could comment a little bit on the partnering efforts for EBX-01. And, in particular, if there's anything that you've heard, either in your feedback from partners or that you think yourself,

Would be particularly important for us to watch for from the upcoming data releases, whether that's the 3-year data or the biomarker community. Is there anything in particular you think is key for driving these partnering discussions?

Helen Tayton-Martin: That's a really good question. I mean, clearly the cancer vaccine space has had something of a checkered past, you know, way back, but more of a renaissance, I think, in the checkpoint era. I think our data is certainly resonating with companies who are interested in the cancer vaccine area, understand the nuances around getting strong antigens, personalized cancer antigens for not just immune recognition, but for clinical benefit. It is a complex therapy to administer, but it is also potentially an effective therapy.

So, so that's a really good question. Um,

Um, and uh, I mean clearly the, the counter vaccine space, uh, in the has had something of a, of a checkered past, uh, you know, way back. But more of a Renaissance. I think in the in the checkpoint era and I think our data is certainly resonating with companies who are interested in in in the cancer vaccine area, understand the nuances around uh getting um,

Helen Tayton-Martin: I think the sorts of things that gain interest are the not just the response rate that we've seen at 2 years, one year, then 2 years at ESMO, but also the response, the recognition of the antigens, the numbers that Birgitte spoke to, and I'll ask her to add comment to this as well. I think we're in a strong position with that data, clinical data package that we have. The translational data, I think, is going to be interesting. It continues to show why and how, you know, the immune response is happening in parallel to the clinical response. That is, I think, a differentiator. Also in the population, the advanced population rather than the adjuvant melanoma population.

Um, not just the response rate that we've seen at two years, one year, then two years in at ESMO, but also the, um,

Helen Tayton-Martin: Clearly, I think we're also seeing interest in this whole approach in other high mutational burden cancers too. Beyond melanoma, I think those are the differentiators, thinking about where else this is, this is applicable, acknowledging 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. Quite a bit of interest. I think the number... to be honest, a number of companies are on the fence, but looking with interest and very interested in the shared approach, the shared antigen approach that our EVX-04 program offers. Birgitte, do you want to add some further comments?

Uh, the response, the recognition of the antigens, the, the numbers that that, that the Gita spoke to, and I'll ask her to to add comments to this as well. So I think the, um, we're in a strong position with with that can with that data, clinical data package that we have the translational data, I think is going to be interesting. It continues to show. Um, why and how the, you know, the immune response is is happening in parallel to the clinical response. So that is, I think, a a differentiator and also in the, the population, the advanced population rather than the agent melanoma population. And clearly, I think we're also seeing interest in this this whole approach in in other. Um, um, mutation High mutational burden uh, cancers too. So beyond melanoma. I think those are the the differentiators thinking about where else this is, this is applicable um acknowledging the the different biological parameters, the translational insights that we're seeing that somewhat different to uh how others have reported on this uh with similar approaches so quite a bit of Interest I think the number of

To be honest, the number of companies are on the fence, but but but looking with interest and very interested in the the shared approach, the shared antigen approach that are, um, a evxo for program offers, um, Spa, do you want to add some further comments?

Birgitte Rønø: 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. 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. This is of course a testament to the precision of our platform. That's one of the key elements.

Doubts that the ability.

No.

And so there's no doubt that the the ability of our AI Immunology platform to identify the relevant targets and is getting a lot of interest from from potential partners and also from the, from the academic, uh, community. And with this 81% hit rate as we call it, um, I think this is very impressive. Um, we have, of course, uh, looked at other similar programs and, uh, seen that most of them are reporting heat rates. Uh, way below. 60%, meaning that uh, the antigens that they are including in their vaccines are not all. Um,

Birgitte Rønø: 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 indications where there are a high mutational burden, meaning that there are several antigens to choose from, and that includes many of the high prevalent cancer indications. It could be non-small cell lung cancer and also some of the colorectal cancers.

Um, a high mutational burden, meaning that there are several engines to choose from, and that includes many of the—

The high prevalent, uh, cancer indications. It could be in small cell lung cancer, and also some of the colorectal cancers.

Michael Okunewitch: Thank you. I appreciate that additional color on that. 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. 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.

Thank you, I appreciate that. Additional color on that, um,

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

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. Um, 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 the best thing to say is it, it's early. Uh, in terms of our, uh, prioritization of the indications. But we've certainly done some work around that are based on parameters, which are bigger if you're happy to comment on that, I think high level in terms of what's guiding where we focus? That would be, that would be good.

Birgitte Rønø: Yes. We have done a lot of analysis on the 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 AI-Immunology. We do have many things in place that can be directly applied in this area. 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.

Yes. So we have, uh, done a lot of analysis on on the most prevalent autoimmune diseases, and we do see a clear fit for for our platform. I mean, we of course, need to, uh, to further improve it and build a few additional, uh, smaller unit that, uh, that allows us to, uh, to apply the Immunology. But, um,

We do have many things in place that can be directly applied in, in this, uh, in this area. Um, so we will, of course, share more, uh, when we have done, uh, both, um, analysis on, on which key indications we will pursue, and also on—

Birgitte Rønø: 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 types of diseases. Not only for autoimmune diseases, but also for other diseases where there is a strong immunological component. Of course, we need to build a little bit, but the majority is already in AI-Immunology.

So, of course, we need to build a little bit, but, uh, the majority is already in AI Immunology.

Michael Okunewitch: All right. Thank you very much. I appreciate your additional comments and look forward to future updates.

Birgitte Rønø: Thank you.

Thank you very much. I appreciate your additional comments and look forward to future updates. Thank you.

Operator: Thank you. Our next question today will come from the line of RK from H.C. Wainwright. Please go ahead.

Thank you.

Our next question today.

Swayampakula Ramakanth: Thank you. This is RK from H.C. Wainwright & Co. Good afternoon, Helen, Birgitte Rønø, and Thomas Schmidt. To start off, Helen, a quick question for you. You know, you have, you know, basically been an architect in multi-billion dollar alliances, at Adaptimmune, you know, especially the large deal that was transacted with GSK. Also you have had a lot of experience in transactions. While Evaxion is technically a very strong company, they've always had a difficulty in translating that language into meaningful transactions. Of course, Merck is pretty strong partner.

Will come from the line of Arkay from HC Wayne Wright. Please go ahead.

um,

And also, you have had a lot of experience, uh, in, in, in transactions.

um, and

Swayampakula Ramakanth: Based on your experiences and how you have managed to translate that, you know, what sort of discussions could you have at this point, especially when talking with large cap pharma, and convince them that an AI tool's predictability is as good as a physical assay, and get them to start looking into some of the products that Evaxion is generating?

While Evaxion is technically a very strong company, there were always had a difficulty in, um, translating that, uh, that language, um, into—into—into meaningful transactions. Of course, Merus, pretty strong partner.

Um, based on your experience, is—and um, how we are managed—to translate that. Um,

You know, what sort of, um,

Discussions—could you have at this point, especially when, um, talking with large-cap pharma, um, and convince them that an AI tool’s predictability is as good as a physical assay, um, and get them to, uh, start looking into, uh, some of the products that, uh, the vaccine is generating.

Helen Tayton-Martin: Hello, RK. Thanks for the question. I think that there's a, there are probably multiple dimensions to that 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. I think actually, the fact that we have the scope to validate and iterate candidates, target discovery with candidate development, with candidate validation is something really novel that isn't sort of generally out there.

Hello, hello. Okay, thanks. Thanks for the question. Um, uh,

Helen Tayton-Martin: 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. I don't think there are many that have got the sort of integrated long sort of longitudinal depth of expertise that Evaxion has. Really this is about crystallizing the offering through the validation of the candidates we have and sort of being in dialogue with the right people. You mentioned my background was a long time, 17 years in my previous 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.

Uh, Target Discovery with candidate development, with candidates candidate, validation is something really novel that isn't sort of generally out there. And when I said timing, there's um, there are obviously many of the large farmer. Most of them will will all have in-house AI platforms running in in 1 form or or another.

Helen Tayton-Martin: Ultimately it's down to relationships and credibility and really having something that fits a need. All I can say at this point is we're working, reworking up some of those approaches and some of those themes in terms of how we are approaching potential partnering interactions. I have to say, though, that the Evaxion team is well-known with quite a few of these groups, but we're building and expanding that profile. I think that that's critical to, you know, the future success in partnering conversations. It's being what you say you are in front of the right people.

Uh, themes, uh, in terms of how we are, um, approaching potential partnering interactions. I have to say though that the team, that the action team is well known with quite a few of these groups. But we're, we're building and expanding that, uh, profile. And I think that that's critical to, um,

Uh, you know, the future success in partnering—conversation. So, it's being what you say you are in front of the right people.

Swayampakula Ramakanth: Perfect. No, thanks for that. 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 assays, or are they requesting from you, are additional work so that they can come to a conclusion?

Point. Um, is this a function of them trying to do additional experiments or functionality, or are they requesting, um, from you, um, additional work so that, um, they can come to a conclusion.

Helen Tayton-Martin: Sorry, you're referring to the extension that they had last year.

sorry, you're referring to the

Swayampakula Ramakanth: Yeah.

Helen Tayton-Martin: before the ultimate decision there. I mean, we can't really comment on obviously the, the combination nature of the interactions. All I can say is that sometimes it's sort of, R&D programs when they are back and forth and shared between organizations don't always run to plan. Sometimes that requires, you know, looking at things again. Ultimately then, you know, there are time frames around things which have to, you know, are followed through. I think that the reasons for not taking it up are sort of obviously their reasons and multi, you know, 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.

Helen Tayton-Martin: We feel very bullish and strong about the data package. You know, but how and why, you know, Merck wanted to do, you know, certain work or is something we can't really, we can't really add any more commentary on.

engine that they had last year um before the offer decision there. Um, I mean we can't really comment on on the the combination of the, the interactions. All I can say is that sometimes it's sort of uh R&D programs when they are back and forth and shared between organizations, don't always run to plan. And so sometimes that requires um, you know, looking at things again but but ultimately, then you know, there are time frames around things which uh, have to, you know, are followed through. So I think that the the reasons for not taking it up a sort of obviously their reasons and multi, you know, multi-dimensional. Um, all I can say is that we remain really, um, excited about the data. We actually continue to build data on the program internally throughout that period of time as well. So so we we we we feel very very bullish and strong about about the data package. Um, you know, but how and why our you know em once wanted to do, you know, set work or is something we can't really, we can't.

Swayampakula Ramakanth: Okay. On the EVX-01 durability, Birgitte. You have shown 92% of the responders showing sustainability via at 24 months. As we are, you know, looking forward to the sort of three-year durability, what sort of exhaustion markers are you going to be tracking so that we understand how well the durability is?

Yeah, um, on the UVX or on durability. Um, Regetta, so you, um—

Birgitte Rønø: Yeah. Thank you for that question, Ake. It's correct that 92% of the responders remained in response up at this two-year mark. I guess your question was related to the T-cell exhaustion.

Swayampakula Ramakanth: Mm-hmm

Birgitte Rønø: markers. Yes.

Swayampakula Ramakanth: Yeah.

Birgitte Rønø: We do deep T cell profiling, looking at activation marker, exhaustion 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. So far we have demonstrated that the profile of the T cells are very favorable, so in more of the activation or effector type of cells and not too many that are having exhaustion markers. We also see that there's like a dominance of CD4 T cells and with some patients are also mounting a CD8 T cells by time.

Part of this is, um, we do a deep-sea cell profiling, looking at activation markers, exhaustion markers, uh, and also at the different phenotypes of the T cells. So including, uh, CD4, CD8, but also looking into whether there are, uh, regulatory T cells coming up, and so far, we

we have uh, demonstrated that

The profile of the TA cells are, um, very favorable. So, in more of the activation or effects type of, uh, of cells, and not—not too many that are, um, that are having exhaustion markers.

Uh, we also see that there's a

Birgitte Rønø: We have, during this extension phase of the study, we have been collecting additional blood samples that are currently being analyzed in our lab. More to come on that. It's very exciting. Since EVX-01 is giving us a monotherapy in this extension phase, we are also very curious of understanding what EVX-01 can drive on its own without having the background of the checkpoint inhibitors.

Like a dominance of CD4 T cells, and with some patients also mounting a CD8 T cell response by time. So we have, during this extension phase of the study, we have

We've been collecting additional, uh, blood samples that are currently being analyzed in our lab, so more to come on that. Um,

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

And, but it's very exciting. And since EVX01 is giving us a monotherapy in this extension phase, we're also very curious to understand what EVX01 can drive on its own without having the background of the checkpoint inhibitors.

Okay, one last question from me. Um, this is on the, um, EVXO for—

Operator: In the interest of time, we will move to our next question. Our next question comes from the line of Soumit Roy from JonesTrading.

In the interest of time, we will move to our next question.

And our next question comes from the line of De Van Hill from Jones.

Soumit Roy: Hi. Thank you for taking our question. On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates? Thank you.

[Analyst] (JonesTrading): Hi. Thank you for taking our question. On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates? Thank you.

Hi, thank you for taking my questions, uh, on the autoimmune disease program. Um, can you provide more detail on your strategy for validating, um, early candidates? Thank you.

Helen Tayton-Martin: Thanks for the question. I mean, it's early. We probably cannot provide more details. Birgitte, do you want to comment on how we think about it?

Birgitte Rønø: Yes. The first step is to settle on an indication. We've done landscaping, we've done dry analysis on looking at the top 10 most prevalent autoimmune diseases, and we are now narrowing down which one could be the most, I would say, interesting from a, from our perspective, whether it's a nice fit for AI-Immunology. That work is ongoing. We've almost completed it. Next step is to focus on building the additional smaller units that we will be needing in AI-Immunology to enable us to develop therapies for these, for these diseases. In parallel, we are also setting up mouse models in our lab, so ensuring that we can also test the candidates that AI-Immunology is designing. That is the current plan.

And we are now narrowing down which one could be the most, um,

Uh, mouse models in our lab, so ensuring that we can also test, um, the candidates that AI Immunology is designing.

Birgitte Rønø: pretty, traditional way of analyzing or testing the candidates that AI-Immunology is designing.

Soumit Roy: Great. Thank you very much.

[Analyst] (JonesTrading): Great. Thank you very much.

Operator: 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.

Helen Tayton-Martin: Thank you very much for everyone participating on the call today. It's been a great year for 2025 of transforming the company full of action, delivering on multiple milestones and 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 assets. Thank you for your questions and your engagement, and we look forward to our next update. Thank you. Bye-bye.

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

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

Q4 2025 Evaxion Biotech AS Earnings Call

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