Evaxion A/S American Depositary Share 2026 Q2 Earnings Call

I'm Helen Tayton-Martin. I'm the Chief Executive of Evaxion, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Rønø, our CSO and COO, who will provide an overview of our updates in our R&D pipeline and AI-Immunology platform. Then I'll hand over to Thomas Schmidt, who will talk through our Q2 financial results before we bring it back to conclusions and Q&A. First, of course, we may make forward-looking statements, and the audience is advised to look at our recently filed SEC documents. Now I'll kick off the discussion. Really Q2 has been marked by a series of achievements in our four core areas or four core platforms for the company. First of all, just focusing on business development.

As previously and ongoing through the course of this year, there are many discussions we are having with partners regarding the Evaxion programs and pipeline. We've had a stream of very encouraging new data, which continues to come through and continuously validate the AI-Immunology platform, which really feeds into those various conversations, and we'll touch on some of those today. In particular, in our R&D area, we have been very pleased to be accepted to present further updates on our EVX-01 program, our personalized neoantigen cancer vaccine in advanced melanoma patients. Obviously, it was a great day for the field yesterday to see the positive phase III results from the similar Moderna Merck program in personalized cancer vaccine in melanoma produced.

It will be great for us and the field to talk more about that as we head into ESMO and an update on our own data there. Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVX-03 and EVX-01 platform actually into a new program, which we call EVX-05 in glioblastoma, where we are further leveraging the ERVs that we have been able to identify, highly conserved ERV antigens for glioblastoma, building on what we have done in our EVX-04 program, using a similar approach to use AI-Immunology to find highly conserved and ERV antigens in AML. So we've presented new preclinical data on that earlier this year at the European Hematology Association annual conference, and we've also updated in our infectious disease portfolio on our EVX-V1 CMV program, too, at the recent International Herpesvirus Workshop last month.

More broadly on AI-Immunology, the platform itself, we were really delighted to see that recognized in the Prix Galien UK award, a second Prix Galien award we have had for the technology in the last 12 months. It is very exciting to see that being recognized more broadly, more globally in terms of the value in AI-Immunology prediction for our programs in infectious disease, oncology, and autoimmune disease. Finally, in terms of the core of our updates, we have maintained a disciplined focus on our resource allocation, really strongly aligned to where we can build the most value from the platform. With that discipline, we can confirm that our cash runway remains unchanged with cash at hand to fund our operations into the second half of 2027, and Thomas will talk more about that.

Just a reminder before we jump into it, our pipeline consists of a number of programs in cancer and infectious disease at the current time. EVX-01 will be a focus for Birgitte's presentation in a few moments, and obviously also including our EVX-04 and EVX-05 programs, which are focused on the conserved ERV off-the-shelf antigen vaccines. In infectious diseases, we have a number of preclinical programs there, and some of which are partnered, one with Merck, one with Aprogen, and data is continuing to build around the interest that we have on those programs from partners.

In terms of where we are, as we meet the halfway point of 2026, we have already met the first of our milestones in terms of updating on the EVX-01 platform at AACR earlier this year with biomarker and immunogenicity preclinical data alongside the clinical data from year 2 at ESMO last year. We have mentioned already, and we will be updating on the 3-year data from that program with efficacy results at ESMO in October. In the rest of the course of this year, we will be talking more about the application of AI-Immunology in autoimmune disease, as well as planning for the regulatory filing of that EVX-04 program, the off-the-shelf program in AML. Finally, we will have an update on our group A strep program with the design and preclinical validation of antigens and the EVX-04.

We continue to prosecute a partnership approach around these programs and platforms where we see value creation. With that, I will hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.

Thank you, Helen. Today, I will focus on our lead asset, EVX-01, our personalized neoantigen cancer vaccine currently in phase II in advanced melanoma. Then I will present our new off-the-shelf EVX-05 vaccine program, demonstrating the scalability of our AI-Immunology platform into the hard-to-treat and deadly brain cancer, glioblastoma. Lastly, I will showcase how AI-Immunology identified T cell epitopes are relevant in controlling CMV infections. As Helen mentioned, we will present three-year EVX-01 phase II outcome data at the ESMO Congress, in October. This data includes evaluation of the vaccine's effect as standalone and also in combination with anti-PD-1 treatment. The data will potentially give further insight into enhanced treatment effects, and also the durability of EVX-01-induced immune responses. Collectively, these data provide a more comprehensive assessment of the full potential of EVX-01 to strengthen the already strong clinical data package.

Looking back at previously announced data from the EVX-01 phase II trial, we reported strong EVX-01 induced immune activation at the AACR meeting in April. We were able to show that 86% of the EVX-01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported for other similar vaccine candidates. Furthermore, we also showed that 86% of the immunogenic vaccine targets induced a de novo T cell response, meaning that EVX-01 specifically triggers novel T cell responses rather than amplifying existing responses. This is very important, as induction of de novo T cell responses has been linked to clinical benefit. At the ESMO Congress last year, we reported two-year outcome data including a 75% overall response rate, 25% complete responses, and 92% of the patients still being in response, indicating durable clinical benefit.

Importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. Over the last approximately 10 years, personalized neoantigen vaccines has shown promise across several early-phase clinical studies. With the Moderna and Merck announcement yesterday, we can definitely say that the field is moving from promising experimental immunotherapy towards a clinically validated therapeutic modality, with a clear and realistic path to regulatory approval. These data are not just only a win for Moderna and Merck, but it is a win for the entire field as they broadly validate the personalized neoantigen vaccine concept. Overall, with our encouraging EVX-01 data and with the validation from Moderna and Merck, we believe that we are well-positioned as we move forward towards further value creation. Let us turn our focus to our off-the-shelf cancer vaccine programs.

In collaboration with Duke University, we are developing an off-the-shelf vaccine, EVX-05, for glioblastoma or GBM, targeting conserved antigens, as announced earlier this week. GBM is the most common and most aggressive primary malignant brain tumor. Despite surgery followed by chemoradiation, outcomes remain very poor, with a median overall survival of approximately one year, underscoring a significant unmet medical need. Our EVX-05 approach builds on the same novel and broadly applicable concept as EVX-04, as it is designed with AI-Immunology to target conserved tumor-specific antigens derived from endogenous retrovirus elements, or ERVs, which are part of the dark genome. The target selection process allows for broad tumor coverage despite immune and tumor ERV antigen differences across patients. We have applied AI-Immunology, our AI-powered target discovery approach, and identified an optimal set of ERV fragments, based on cross-patient relevance and immunogenic potential.

And we have mined patient sequencing data, identifying approximately 1.5 million ERV fragments and selected 16 of these as the fragments that will be included in the EVX-05 vaccine. Next steps include lead candidate selection and IND-enabling activities prior to a first-in-human study that is expected to be conducted in collaboration with the world-leading GBM experts we are collaborating with at Duke University. Our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. EVX-01 targets multiple conserved ERVs, in the case of this program, identified in AML patient samples. As Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVX-04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation.

Further, we showed that the 16 ERV targets included in the EVX-04 vaccine activate human immune cells across different HLA types, and that these ERV-reactive immune cells can mediate targeted cell killing, indicating not only immune recognition but also relevant functional impact of these vaccine-induced immune cells. Collectively, these data highlights EVX-04's potential as a new, effective therapeutic cancer vaccine, and we look forward to reporting further data as the program progresses towards regulatory filing later this year. Another promising program presented at a scientific conference during the summer is our EVX-V1 cytomegalovirus or CMV vaccine program. In EVX-V1, we are using AI-Immunology to design known targets, optimizing them, and also to identify previously unexplored vaccine targets.