Evaxion A/S

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

Thank you, speaker. I'm Helen Tayton-Martin. I'm the chief executive of Oveaction, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Rono, 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. So first, of course, we may make forward looking statements and the audience is advised to look at our recently filed SEC documents. And now I'll kick off the discussion. So really Q2 has been marked by a series of achievements in our four core areas of 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 evaction 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. And in particular, in our R&D area, we have been very pleased to be accepted to present further updates on our EVXO1 program, our personalized neoantigen cancer vaccine in advanced melanoma patients. and obviously it was a great day for the field yesterday to see the positive phase three results from the similar Moderna Merck program in personalized cancer vaccine in melanoma produced and so 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 EVXO3 and EVXO1 platform actually into a new program which we call EVXO5 in glioblastoma where we are further leveraging the herbs that we have been able to identify highly conserved herb antigens for glioblastoma building on what we have done in our EVXO4 program using a similar approach to use AI immunology to find highly conserved and herb antigens in AML. So we've presented new preclinical data on that earlier this year at the European Haematology Association conference, annual conference. And we've also updated in our infectious disease portfolio on EVXV1, CMV program two at the recent HSE, Herpes Sublux conference last month. More broadly on AI immunology, the platform itself, we were really delighted to see that recognized in the Galeon UK award, a second Galeon award we have had for the technology in the last 12 months. So 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. And 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. And with that discipline, we can confirm that our cash runway remains unchanged with cash at hand funder operations into the second half of 2027. And Thomas will talk more about that. So 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. EVXO1 will be a focus for Birgitte's presentation in a few moments and obviously also including our EVXO4 and EVXO5 programmes which are focused on the conserved of off-the-shelf antigen vaccines. In infectious diseases we have a number of preclinical programmes there and some of which are partnered, one with Merck, one with Afrogen and data is continuing to build around the interest that we have on those programmes from partners. So, 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 EBX01 platform at AACR earlier this year with biomarker and immunogenicity preclinical data alongside the clinical data from year two at ESMO last year. We have mentioned already and we will be updating on the three year data from that program with efficacy results at ESMO in October. And in the rest of this 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 EVXO4 program, the off-the-shelf program in AML. and finally we will have an update on our Group A strep program with the design and preclinical validation advantages in their EVXB4 and we continue to prosecute a partnership approach around these programs and platforms where we see value creation. So with that I'll hand over to Nagita who will talk you through our R&D and AI immunology update.

Thank you Helen. So today I'll focus on our lead asset EVXO1 so that our personalized new antigen cancer vaccine currently in phase two in advanced melanoma. Then I'll present our new official vaccine program demonstrating the stability of our AI immunology platform into the hard to treat and deadly brain cancer glioblastoma. So lastly, I'll showcase how AI immunology identified T cell epitopes are relevant in controlling So, as Helen mentioned, we'll present three-year effects or one phase two outcome data at the ESMO Congress in October. And this data includes evaluation of the vaccine's effect as a standalone and also in combination with anti-PD1 treatment. The data will potentially give further insight into enhanced treatment effects and also the durability of EVX01-induced immune responses. And collectively, these data provide a more comprehensive assessment of the full potential of EVX01, so strengthening the already strong clinical data package. So looking back at previously announced data from the EVX01 phase 2 trial, we reported strong EVX01-induced immune activation at the AACR meeting in April. So we were able to show that 86% of the EVX01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported and other similar vaccine candidates. Furthermore, we also showed that 86% of the immunogenic vaccine targets induced a de novo T cell response, meaning that EVXL1 specifically triggers novel T cell responses rather than amplifying existing responses. And this is very important as induction of de novo T cell responses has been linked to clinical benefit. And at the ESMO Congress last year, we recorded 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. And importantly, more than half of the patients converted into and improve clinical response upon EVXO1 treatment. So over the last approximately 10 years, personalized new antigen vaccines have shown promise across several early phase clinical studies. And with the Moderna America 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. And these data are not just only a win for Moderna and Merck, but it's a win for the entire field as they boldly validate the personalized new antigen vaccine concept. So overall, with our encouraging EVXO1 data, and with the validation from Moderna and Merck, we believe that we are well-positioned as we move forward towards further value creation. So let's turn our focus to our off-the-shelf cancer vaccine programs. So in collaboration with Duke University, we are developing an off-the-shelf vaccine EVXO5 for glioblastoma or GVM. targeting conserved antigens as announced earlier this week. So GBM is the most common and most aggressive primary malignant tumor, brain tumor, and despite surgery followed by chemoradiation, outcomes remain very poor with a median overall survival of approximately one year underscoring a significant unmet medical need. So our EVEXO5 approach builds on the same novel and broadly applicable concept as EDX04 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. So we have applied AI immunology, so our AI-powered target discovery approach, and identified an optimal set of earth fragments based on cross-patient relevance and immunogenic potential. And we have mined patient sequencing data, identifying approximately 1.5 million ERG fragments and selected 16 of these as the fragments that will be included in the EVXO5 vaccine. So 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 and GDM experts we are collaborating with at Duke University. So our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. So EVX-01 targets multiple conserved IRFs in the case of this program identified in AML patient samples. So as Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVXO4 vaccine is expressed and secreted by human cells, enabling immune recognition and activation. So further, we showed that the 16 ERG targets included in the EVXO4 vaccine activate human immune cells across different HLA types, and that these active immune cells can mediate targeted cell killing, indicating not only immune recognition, but also relevant functional impact of these vaccine-induced immune cells. So collectively, these data highlight and E.V.X. or false potential as a new effective therapeutic cancer vaccines. And we look forward to reporting further data as the program progresses towards regulatory filing data this year. So another promising program presented at a scientific conference during the summer is our E.V.X. V1 for the cytomegalovirus or CMV vaccine program. So in EVXV1, we are using AI immunology to design a known target, so optimizing them, and also to identify previously unexplored vaccine targets. And at the International Herpes Virus Workshop in July, we presented new data demonstrating that T-cell epitopes discovered with AI immunology have the potential to control acute infection, latency, and also reactivation in CMV-infected mice. And this is a key finding, as it complements previous results, demonstrating the ability of both novel and optimized known B-cell antigens to reduce viral infection. And the data will guide antigen selection a broadly protected CMV vaccine candidate and as such represent a very important step towards forward for the EDX V1 program. So having highlighted progress across our key R&D programs, let's now focus on our AI immunology platform. and the data validating its ability to generate high quality product candidates. So AI Immunology is clinically validated with positive outcome in three out of three oncology trials. Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ERV targeting vaccines, as well as in infectious diseases. with several candidates against bacterial and viral pathogens. And importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. And additionally, the novel earth-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. So finally, AI Immunology supports multiple modalities, including peptides, recombinant proteins, DNA and RNA platforms, enabling both pipeline and partnering procedures. So in conclusion, we've demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. So with that, I'll hand over to Thomas who will present our quarterly financial results.