Q2 2026 Evaxion Biotech AS Earnings Call And Business Update Call
Operator: Good day, and thank you for standing by. Welcome to the Evaxion business update and Q2 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 one and one on your telephone. You will then 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, Helen Tayton-Martin, CEO. Please go ahead.
Operator: Good day, and thank you for standing by. Welcome to the Evaxion business update and Q2 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 one and one on your telephone. You will then 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, Helen Tayton-Martin, CEO. Please go ahead.
Speaker #1: After the speaker's presentation, there will be a Q&A session. To ask a question during the session, you will need to press *1 and *1 on your telephone.
Speaker #1: You will then hear an automated message advising your hand is raised. To withdraw your question, please press *1 and *1 again. Please be advised that today's conference is being recorded.
Speaker #1: I would now like to hand the conference over to your speaker today, Helen Dayton Martin, CEO. Please go ahead.
Speaker #2: Thank you, speaker. I'm Helen Dayton 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 Rono, our CFO and COO, who will provide an overview of our updates in our R&D pipeline and AI immunology platform.
Helen Tayton-Martin: Thank you, speaker. I am Helen Tayton-Martin. I am the Chief Executive of Evaxion, and we are delighted today to be presenting our Q2 business update. I am 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 will 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 will 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.
Helen Tayton-Martin: Thank you, speaker. I am Helen Tayton-Martin. I am the Chief Executive of Evaxion, and we are delighted today to be presenting our Q2 business update. I am 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 will 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 will 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.
Speaker #2: 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.
Speaker #2: And now I'll kick off the discussion. So really, Q2 has been marked by a series of achievements in our four core areas or four core platforms for the company.
Speaker #2: 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.
Helen Tayton-Martin: 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 have 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 will 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.
Helen Tayton-Martin: 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 have 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 will 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.
Speaker #2: We've had a new stream of very encouraging data, which continues to come through and continuously validate the AI immunology platform. This really feeds into those various conversations.
Speaker #2: 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.
Speaker #2: And 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.
Speaker #2: 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.
Helen Tayton-Martin: 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 ERV antigens in AML. We presented new preclinical data on that earlier this year at the European Hematology Association annual conference. We have also updated in our infectious disease portfolio on our EVX-V1 CMV program too at the recent IHW conference last month.
Helen Tayton-Martin: 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 ERV antigens in AML. We presented new preclinical data on that earlier this year at the European Hematology Association annual conference. We have also updated in our infectious disease portfolio on our EVX-V1 CMV program too at the recent IHW conference last month.
Speaker #2: Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVX03 and EVX01 platform, actually, into a new program, which we call EVX05 in glioblastoma. Here, we are further leveraging the ERVs—we have been able to identify highly conserved ERV antigens for glioblastoma—building on what we have done in our EVX04 program using a similar approach, to use AI immunology to find highly conserved ERV antigens in AML.
Speaker #2: So, we've presented new preclinical data on that earlier this year at the European Hematology Association annual conference, and we've also updated our infectious disease portfolio on our EVX-V1 CMV program too, at the recent HSV (herpes simplex) conference last month.
Speaker #2: More broadly, on AI immunology, the platform itself—we were really delighted to see that recognized with the Galeon UK Award, the second Galeon Award we have had for the technology in the last 12 months.
Helen Tayton-Martin: 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 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. 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 H2 2027, and Thomas will talk more about that. Just a reminder before we jump into it.
Helen Tayton-Martin: 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 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. 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 H2 2027, and Thomas will talk more about that. Just a reminder before we jump into it.
Speaker #2: It's very exciting to see this being recognized more broadly and globally in terms of the value of AI immunology prediction for our programs in infectious disease, oncology, and autoimmune disease.
Speaker #2: 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.
Speaker #2: And 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.
Speaker #2: And Thomas will talk more about that. So, just a reminder before we jump into it, the pipeline consists of a number of programs in cancer and infectious disease at the current time.
Helen Tayton-Martin: 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 and 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 Afrigen Biologics, 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.
Helen Tayton-Martin: 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 and 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 Afrigen Biologics, 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.
Speaker #2: EVXO1 will be a focus for Birgitte's presentation in a few moments, and obviously, also including our EVXO4 and EVXO5 programs, which are focused on the conserved ERV and off-the-shelf antigen vaccines.
Speaker #2: In infectious diseases, we have a number of preclinical programs—some of which are partnered, one with Merck and one with Afrigen—and data is continuing to build around the interest that we have on those programs from partners.
Speaker #2: 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 EVXO1 platform at AACR earlier this year, with biomarker and immunogenicity preclinical data, alongside the clinical data from year two at ESMO last year.
Speaker #2: As we have mentioned already, we will be updating on the three-year data from that program with efficacy results at ESMO in October. For the rest 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 the EVX-04 program, the off-the-shelf program in AML.
Helen Tayton-Martin: 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 their EVX-V4. 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.
Helen Tayton-Martin: 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 their EVX-V4. 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.
Speaker #2: And finally, we will have an update on our Group A Strep program with a design and preclinical validation of antigens in the EVX-B4. And we continue to prosecute a partnership approach around these programs and platforms, where we see value creation.
Speaker #2: So with that, I'll hand over to Birgitte, who will talk you through our R&D and AI immunology update.
Speaker #3: Thank you, Helen. So today, I'll focus on our lead asset, EVX01, our personalized neoantigen cancer vaccine currently in Phase II in advanced melanoma.
Birgitte Rønø: 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 strengthening the already strong clinical data package.
Birgitte Rønø: 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 strengthening the already strong clinical data package.
Speaker #3: Next, I'll present our new off-the-shelf EVX05 vaccine program, demonstrating the scalability of our AI immunology platform into the hard-to-treat and deadly brain cancer, glioblastoma.
Speaker #3: So, lastly, I'll showcase how AI immunology-identified T-cell epitopes are relevant in controlling CMV infections. As Helen mentioned, we'll present three-year EVX-01 Phase II outcome data at the ESMO Congress in October.
Speaker #3: These data include evaluation of the vaccine's effect as a standalone, as well as in combination with anti-PD-1 treatment. The data will potentially provide further insight into enhanced treatment effects and the durability of EVX-01-induced immune responses.
Speaker #3: And collectively, these data provide a more comprehensive assessment of the full potential of EVXO1 to strengthen the already strong clinical data package. So, looking back at previously announced data from the EVXO1 Phase II trial, we reported strong EVXO1-induced immune activation at the AACR meeting in April.
Birgitte Rønø: 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.
Birgitte Rønø: 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.
Speaker #3: So, we were able to show that 86% of the EVXO1 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported for other similar vaccine candidates.
Speaker #3: Furthermore, we also showed that 86% of the immunogenic vaccine targets induced a de novo T-cell response, meaning that EVX01 specifically triggers novel T-cell responses rather than amplifying existing responses.
Speaker #3: And 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.
Birgitte Rønø: 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 have 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.
Speaker #3: And importantly, more than half of the patients converted to an improved clinical response upon EVX01 treatment. So, over the last approximately ten years, personalized neoantigen vaccines have shown promise across several early phase clinical studies.
Birgitte Rønø: 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 have 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.
Speaker #3: And 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.
Speaker #3: And these data are not just a win for Moderna and Merck, but it's a win for the entire field, as they broadly validate the personalized neoantigen vaccine concept.
Speaker #3: 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.
Speaker #3: So, let's turn our focus to our off-the-shelf cancer vaccine programs. In collaboration with Duke University, we are developing an off-the-shelf vaccine, EVX05, for glioblastoma, or GBM, targeting conserved antigens, as announced earlier this week.
Birgitte Rønø: 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 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. 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.
Birgitte Rønø: 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 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. 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.
Speaker #3: So, GBM is the most common and most aggressive primary malignant 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.
Speaker #3: So, our EVXO5 approach builds on the same novel and broadly applicable concept as EVXO4, 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.
Speaker #3: The target selection process allows for broad tumor coverage, despite immune and tumor ERF antigen differences across patients. So, we have applied AI immunology in our AI-powered target discovery approach and identified an optimal set of ERF fragments based on cross-patient relevance and immunogenic potential.
Speaker #3: And we have mined patient sequencing data, identifying approximately 1.5 million ERF fragments, and selected 16 of these as the fragments that will be included in the EVX05 vaccine.
Birgitte Rønø: And we have mined the 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 R&D 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.
Birgitte Rønø: And we have mined the 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 R&D 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.
Speaker #3: 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 GBM experts we are working with at Duke University.
Speaker #3: So, our other off-the-shelf cancer vaccine program, EVX04, is also progressing well. EVX01 targets multiple conserved ERFs—in this case, the ERFs identified in AML patient samples.
Speaker #3: So, as Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVX04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation.
Speaker #3: Further, we showed that the 16 ERF targets included in the EVX04 vaccine activate human immune cells across different HLA types, and that these ERF-reactive immune cells can mediate targeted cell killing, indicating not only immune recognition but also the relevant functional impact of these vaccine-induced immune cells.
Birgitte Rønø: 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.
Birgitte Rønø: 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.
Speaker #3: So, collectively, these data highlight EVX04'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.
Speaker #3: So another promising program presented at a scientific conference during the summer is our EVXV1 cytomegalovirus, or CMV vaccine program. So in EVXV1, we are using AI immunology to design known targets, so optimizing them and also to identify previously unexplored vaccine targets.
Speaker #3: And at the International Herpesvirus 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.
Birgitte Rønø: At the International Herpesvirus 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. 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. The data will guide antigen selection for a broadly protective CMV vaccine candidate, and as such, represent a very important step forward for the EVX-V1 program. 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. AI-Immunology is clinically validated with positive outcome in 3 out of 3 oncology trials.
Birgitte Rønø: At the International Herpesvirus 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. 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. The data will guide antigen selection for a broadly protective CMV vaccine candidate, and as such, represent a very important step forward for the EVX-V1 program. 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. AI-Immunology is clinically validated with positive outcome in 3 out of 3 oncology trials.
Speaker #3: 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.
Speaker #3: And the data will guide antigen selection for a broadly protective CMV vaccine candidate and, as such, represent a very important step forward for the EVX-V1 program.
Speaker #3: 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.
Speaker #3: So, AI immunology is clinically validated with positive outcomes in three out of three oncology trials. Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer, with our ERF-targeting vaccines, as well as in infectious diseases.
Birgitte Rønø: Pre-clinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ER targeting vaccines, as well as in infectious diseases with several candidates against bacterial and viral pathogens. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. Additionally, the novel ER-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. Finally, AI-Immunology supports multiple modalities, including peptides, recombinant proteins, DNA and RNA platforms enabling both pipeline and partnering potential. In conclusion, we've demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. With that, I'll hand over to Thomas, who will present our quarterly financial results.
Birgitte Rønø: Pre-clinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ER targeting vaccines, as well as in infectious diseases with several candidates against bacterial and viral pathogens. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. Additionally, the novel ER-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. Finally, AI-Immunology supports multiple modalities, including peptides, recombinant proteins, DNA and RNA platforms enabling both pipeline and partnering potential. In conclusion, we've demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. With that, I'll hand over to Thomas, who will present our quarterly financial results.
Speaker #3: We have several candidates against bacterial and viral pathogens. Importantly, the EVX01 concept is highly scalable, with potential in other solid tumors. Additionally, the novel ERF-based cancer vaccine concept is used in both our off-the-shelf programs, EVX04 and EVX05.
Speaker #3: So finally, AI Immunology supports multiple modalities, including peptides, recombinant proteins, DNA, and RNA platforms, enabling broad pipeline and partnering potential. So in conclusion, we've demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress.
Speaker #3: So with that, I'll hand over to Thomas, who will present our quarterly financial results.
Speaker #1: Perfect. Thank you, Birgitte. And let me jump straight into the presentation of the financial result for the second quarter of 2026. The main highlights to start with that for the quarter is that we have indeed continued our disciplined resource allocation throughout our strategy direction, of course, and certainly also very much aligned to the priorities around value drivers that we have defined and also communicated earlier for this year.
Thomas Frederik Schmidt: Perfect. Thank you, Birgitte. Let me jump straight into the presentation of the financial results for Q2 2026. The main highlights to start with for the quarter is that we have indeed continued our disciplined resource allocation throughout our strategy direction, of course, and certainly also very much aligned to the priorities around value drivers that we have defined and also communicated earlier for this year. So full alignment and full progress on those elements. We are certainly also on track to deliver according to our financial plan, which both shows in the Q2 results but certainly also confirmed from the cash position that we do have. The cash position, we can reconfirm, as mentioned by Helen already, that we have a cash runway that runs into H2 2027. So reconfirmed and maintained from earlier communication also.
Thomas Schmidt: Perfect. Thank you, Birgitte. Let me jump straight into the presentation of the financial results for Q2 2026. The main highlights to start with for the quarter is that we have indeed continued our disciplined resource allocation throughout our strategy direction, of course, and certainly also very much aligned to the priorities around value drivers that we have defined and also communicated earlier for this year. So full alignment and full progress on those elements. We are certainly also on track to deliver according to our financial plan, which both shows in the Q2 results but certainly also confirmed from the cash position that we do have. The cash position, we can reconfirm, as mentioned by Helen already, that we have a cash runway that runs into H2 2027. So reconfirmed and maintained from earlier communication also.
Speaker #1: So, full alignment and full progress on those elements. We are certainly also on track to deliver according to our financial plan, which is reflected both in the Q2 results and, certainly, is also confirmed by the cash position that we have.
Speaker #1: And the cash position—we can reconfirm, as mentioned by Helen already, that we have a cash runway that extends into the second half of 2027.
Speaker #1: So reconfirmed and maintained from earlier communication also. Looking a little bit closer to our profit and loss statement for the quarter, overall we see slightly reduced operating expenses, mainly driven by our general and administration costs—the G&A costs—where we have significantly lower capital market costs in Q2 compared to the same period last year.
Thomas Frederik Schmidt: Looking a little bit closer to our profit and loss statement for the quarter. Overall, we see a slightly reduced operating expenses, mainly driven from our general and administration costs or the G&A costs, where we have significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses do show a slight increase versus last year, but it is fully aligned with all the progress that Birgitte just mentioned on EVX-01, EVX-04, EVX-05. Again, also those programs are confirmed within our cash runway until the half year to 2027. We reported a net loss for the period of DKK 3.7 million. Again, as mentioned already, on plan and following the execution that we have set for this year. Balance sheet. We have a cash position at the end of the quarter of DKK 14 million.
Thomas Schmidt: Looking a little bit closer to our profit and loss statement for the quarter. Overall, we see a slightly reduced operating expenses, mainly driven from our general and administration costs or the G&A costs, where we have significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses do show a slight increase versus last year, but it is fully aligned with all the progress that Birgitte just mentioned on EVX-01, EVX-04, EVX-05. Again, also those programs are confirmed within our cash runway until the half year to 2027. We reported a net loss for the period of DKK 3.7 million. Again, as mentioned already, on plan and following the execution that we have set for this year. Balance sheet. We have a cash position at the end of the quarter of DKK 14 million.
Speaker #1: On the R&D front, expenses do show a slight increase versus last year, but it is fully aligned with all the progress that Birgitte just mentioned on EVX01, EVX04, EVX05.
Speaker #1: And again, also, those programs are confirmed within our cash runway until the half year to 2027. We reported a net loss for the period of $3.7 million—again, as mentioned already—on plan and following the execution that we've set for this year.
Speaker #1: Balance sheet: We have a cash position at the end of the quarter of $14 million. We are again reconfirming our cash runway. The equity that we also have reflects the result for the first six months.
Thomas Frederik Schmidt: We are again reconfirming our cash runway and the equity that we also have reflects the result for the first 6 months, meaning that we are at DKK 9.5 million at the end of Q2, reflecting that versus last year of the net result. All in all, a good financial performance aligned with expectation and certainly aligned with the progress of our platform and portfolio. With that, I hand it back to Helen for some concluding remarks.
Thomas Schmidt: We are again reconfirming our cash runway and the equity that we also have reflects the result for the first 6 months, meaning that we are at DKK 9.5 million at the end of Q2, reflecting that versus last year of the net result. All in all, a good financial performance aligned with expectation and certainly aligned with the progress of our platform and portfolio. With that, I hand it back to Helen for some concluding remarks.
Speaker #1: Meaning that we are at $9.5 million at the end of the second quarter, reflecting that versus last year’s net result. So, all in all, a good financial performance aligned with expectations and certainly aligned with the progress of our platform and portfolio.
Speaker #1: And with that, I hand it back to Helen for some concluding remarks.
Speaker #2: Thanks, Thomas, and thanks, Birgitte. So, in conclusion, I want to emphasize that we've seen some really good operational momentum on our set milestones and actually, with a new program emerging—EVX05—from all of our activities.
Helen Tayton-Martin: Thanks, Thomas, and thanks, Birgitte. In conclusion, I would want to emphasize that we have seen some really good operational momentum on our set milestones and actually with a new program emerging with EVX-05 from all of our activities, but still maintaining our cash runway into H2 2027. We are really excited by the stream of new data that we have continued to generate with the team that continues to validate that AI-Immunology can deliver products, real meaningful products for future development. That is the core underneath all of our ongoing business development discussions as we continue to process which programs that we bring forward and with which partners. With that, we are very happy to take questions. Thank you for your attention.
Helen Tayton-Martin: Thanks, Thomas, and thanks, Birgitte. In conclusion, I would want to emphasize that we have seen some really good operational momentum on our set milestones and actually with a new program emerging with EVX-05 from all of our activities, but still maintaining our cash runway into H2 2027. We are really excited by the stream of new data that we have continued to generate with the team that continues to validate that AI-Immunology can deliver products, real meaningful products for future development. That is the core underneath all of our ongoing business development discussions as we continue to process which programs that we bring forward and with which partners. With that, we are very happy to take questions. Thank you for your attention.
Speaker #2: But still maintaining our cash runway into the second half of 2027. We're really excited by the stream of new data that we've continued to generate with the team, which continues to validate that AI immunology can deliver meaningful products for future development.
Speaker #2: And that is the core underneath all of our ongoing business development discussions, as we continue to process which programs we bring forward and with which partners.
Speaker #2: So with that, we are very happy to take questions, and thank you for your attention.
Speaker #4: Thank you. To ask a question, you will need to press star one one on your telephone and wait for your name to be announced.
Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. One moment for our first question. This question comes from Thomas Patton from Lake Street Capital Markets. Please go ahead.
Operator: Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. One moment for our first question. This question comes from Thomas Patton from Lake Street Capital Markets. Please go ahead.
Speaker #4: To withdraw your question, please press star one, and then one again. One moment for our first question. This question comes from Thomas Flatten from Lake Street Capital Markets.
Speaker #4: Please go ahead.
Speaker #1: Good morning, everybody. Just two questions on EVX05. I was curious if you could perhaps delineate when we might expect to see some more news out of that program.
Thomas Patton: Good morning, everybody. Just two questions on EVX-05. I was curious if you could perhaps delineate when we might expect to see some more news out of that program. Then if you could elaborate a little bit on the specific role that Duke played in the development up to date.
Thomas Flaten: Good morning, everybody. Just two questions on EVX-05. I was curious if you could perhaps delineate when we might expect to see some more news out of that program. Then if you could elaborate a little bit on the specific role that Duke played in the development up to date.
Speaker #1: And then, if you could elaborate a little bit on the specific role that Duke played in the development up to date.
Operator: Sure. Birgitte?
Helen Tayton-Martin: Sure. Birgitte?
Speaker #2: Sure. Birgitte?
Birgitte Rønø: Well, the collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic. So we received sequencing data for some of those, and we're able to identify. First, we did our personalized approach, looking into the profiles of the ERV and neoantigen expression. Then, as EVX-04 were in parallel progressing and this off-the-shelf concept were developing, we were able to use some of the same approaches, and analyze these samples for identifying conserved ERVs. We were very pleased to see that across these many patients, there were shared features indicating that we could definitely generate an off-the-shelf or design an off-the-shelf therapy. It's still, as I mentioned, a bit early in the development path.
Birgitte Rønø: Well, the collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic. So we received sequencing data for some of those, and we're able to identify. First, we did our personalized approach, looking into the profiles of the ERV and neoantigen expression. Then, as EVX-04 were in parallel progressing and this off-the-shelf concept were developing, we were able to use some of the same approaches, and analyze these samples for identifying conserved ERVs. We were very pleased to see that across these many patients, there were shared features indicating that we could definitely generate an off-the-shelf or design an off-the-shelf therapy. It's still, as I mentioned, a bit early in the development path.
Speaker #3: Yeah, so the collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic.
Speaker #3: So, we received sequencing data for some of those and were able to identify—first, we did our personalized approach, looking into the profiles of the ERV and neoantigen expression.
Speaker #3: And then, as EVXO4 was progressing in parallel and this off-the-shelf concept was developing, we were able to use some of the same approaches and analyze these samples for identifying conserved ERVs.
Speaker #3: And we were very pleased to see that, across these many patients, there were shared features indicating that we could definitely generate an off-the-shelf, or design an off-the-shelf, therapy.
Speaker #3: It's still, as I mentioned, a bit early in the development path. We have conducted and concluded on what we would call target discoveries—so, selecting the targets that will be included in the vaccine.
Birgitte Rønø: We have conducted and concluded on what we would call target discovery, so selecting the targets that will be included in the vaccine, and we are now heading towards lead selection. We have designed several different candidates that are now being experimentally tested. Then it is the classical path with R&D enabling activities and then a first-in-human study. We have not yet settled entirely on a timeline for all of these activities, but that is what we are working on at the moment.
Birgitte Rønø: We have conducted and concluded on what we would call target discovery, so selecting the targets that will be included in the vaccine, and we are now heading towards lead selection. We have designed several different candidates that are now being experimentally tested. Then it is the classical path with R&D enabling activities and then a first-in-human study. We have not yet settled entirely on a timeline for all of these activities, but that is what we are working on at the moment.
Speaker #3: And we are now heading towards lead selection. We've designed several different candidates that are now being experimentally tested. Then it's the classical path, with R&D enabling activities, and then a first-in-human study.
Speaker #3: We have not yet settled entirely on a timeline for all of these activities, but that's what we are working on at the moment.
Helen Tayton-Martin: More to come.
Helen Tayton-Martin: More to come.
Speaker #2: So more to come.
Birgitte Rønø: More to come, definitely.
Birgitte Rønø: More to come, definitely.
Speaker #3: More to come, definitely.
Speaker #2: Thank you.
Thomas Patton: Thank you.
Helen Tayton-Martin: Thank you.
Birgitte Rønø: Yeah.
Birgitte Rønø: Yeah.
Speaker #4: Thank you. We are now going to move to our next question, and this one comes from RK from HC Wainwright. Please go ahead.
Operator: Thank you. We are now going to move to our next question, and this one comes from RK from H.C. Wainwright. Please go ahead.
Operator: Thank you. We are now going to move to our next question, and this one comes from RK from H.C. Wainwright. Please go ahead.
Speaker #5: Thank you. Good afternoon, Helen, Birgitte, and Thomas. A few questions from me, but let me—hopefully I can go one at a time. Starting off on EVX01, obviously it was exciting to see today's news from the Merck-Moderna collaboration.
[Analyst] (H.C. Wainwright): Thank you. Good afternoon, Helen, Birgitte, and Thomas. There are a few questions from me, but let me, hopefully, I could go one at a time. Starting off on EVX-01, obviously, it was exciting to see yesterday's news from the Merck Moderna collaboration, because it validates the program that you have been working on for a while now. Going into ESMO, for the three-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability result, especially in the standalone vaccine period? How would that help your discussions with either the partners that are currently looking at this program or even the AI model itself that helped generate EVX-01 on a broader perspective?
Ramakanth Swayampakula: Thank you. Good afternoon, Helen, Birgitte, and Thomas. There are a few questions from me, but let me, hopefully, I could go one at a time. Starting off on EVX-01, obviously, it was exciting to see yesterday's news from the Merck Moderna collaboration, because it validates the program that you have been working on for a while now. Going into ESMO, for the three-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability result, especially in the standalone vaccine period? How would that help your discussions with either the partners that are currently looking at this program or even the AI model itself that helped generate EVX-01 on a broader perspective?
Speaker #5: Because it validates the program that you have been working on for a while now. So, going into ESMO for the three-year EVX01 extension data, Birgitte, what would you consider a clinically meaningful durability result?
Speaker #5: That's especially true in the standalone vaccine period. And how would that help your discussions with either the partners that are currently looking at this program, or even the AI model itself that helped generate EVX-01?
Speaker #5: On a broader perspective.
Speaker #3: Yeah. So for the EVXO1 clinical data that we would like to see at ESMO, it is basically that we have almost the same or even improved overall response rate.
Birgitte Rønø: Yeah. So for the EVX-01 clinical data that we would like to see at ESMO is basically that we have almost the same or even improved overall response rates. We should remember that these patients, advanced melanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the five-year mark are actually having a severe disease or even passed away. So there is definitely a high unmet medical need for these patients. So we would like to see that we have durable responses, so the same number of patients remains in response as at the two-year mark, and further, that the T cell responses are maintained. So that is, we would consider that as positive data, positive outcome of this expansion phase.
Birgitte Rønø: Yeah. So for the EVX-01 clinical data that we would like to see at ESMO is basically that we have almost the same or even improved overall response rates. We should remember that these patients, advanced melanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the five-year mark are actually having a severe disease or even passed away. So there is definitely a high unmet medical need for these patients. So we would like to see that we have durable responses, so the same number of patients remains in response as at the two-year mark, and further, that the T cell responses are maintained. So that is, we would consider that as positive data, positive outcome of this expansion phase.
Speaker #3: So we should remember that these patients—advanced melanoma patients—if they only receive checkpoint inhibitors, then almost half of them by the five-year mark are actually having severe disease or have even, yeah, passed away.
Speaker #3: So there is definitely a high unmet medical need for these patients. So, we would like to see that we have durable responses—so the same number of patients remains in response as at the two-year mark.
Speaker #3: And further, that the T-cell responses are maintained. So, we would consider that as positive data—a positive outcome of this extension phase. And then you had an additional comment around how this data would potentially support partnership discussions.
[Analyst] (H.C. Wainwright): Thank you.
Ramakanth Swayampakula: Thank you.
Birgitte Rønø: And then you had an additional comment around how this data would potentially support partner-
Birgitte Rønø: And then you had an additional comment around how this data would potentially support partner-
[Analyst] (H.C. Wainwright): Yes
Ramakanth Swayampakula: Yes
Birgitte Rønø: partnership discussions. So there is no doubt that the more positive data we can generate would be appreciated in these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive or supports us in these discussions. The whole field has been waiting for these phase III data for a long time. And it is not just a win for Moderna and Merck, but it is actually a win for the whole field. So definitely, we see this as very encouraging and positive and not just bad competitor news. It is very positive.
Birgitte Rønø: partnership discussions. So there is no doubt that the more positive data we can generate would be appreciated in these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive or supports us in these discussions. The whole field has been waiting for these phase III data for a long time. And it is not just a win for Moderna and Merck, but it is actually a win for the whole field. So definitely, we see this as very encouraging and positive and not just bad competitor news. It is very positive.
Speaker #3: Yeah. So there's no doubt that the more positive data we can generate would be appreciated in these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely is also supportive, or supports us, in these discussions.
Speaker #3: We have been waiting—the whole field has been waiting—for these phase 3 data for a long time. And it’s not just a win for Moderna and Merck, but it’s actually a win for the whole field.
Speaker #3: So definitely, we see this as very encouraging and positive, and not just, yeah, bad competitor news. It's very positive.
[Analyst] (H.C. Wainwright): Perfect. Then going on to the off-the-shelf molecule, EVX-04. In terms of getting it ready to get into the clinic, what are the gating steps here? Is it manufacturing? Is it CMC or making sure that you have enough investigators who will do the right thing when you start taking this into the clinic?
Ramakanth Swayampakula: Perfect. Then going on to the off-the-shelf molecule, EVX-04. In terms of getting it ready to get into the clinic, what are the gating steps here? Is it manufacturing? Is it CMC or making sure that you have enough investigators who will do the right thing when you start taking this into the clinic?
Speaker #5: Perfect. Then, going on to the off-the-shelf molecule EVXO4, in terms of getting it ready to get into the clinic, what are the gating steps here?
Speaker #5: Is it manufacturing? Is it CMC, or making sure that you have enough investigators who will do the right thing when you start taking this into the clinic?
Speaker #3: Yeah, so EVX04 is—we have done target discovery, we have selected the lead, and now we are conducting R&D enabling activities. That includes GMP manufacturing, and then of course we need to check that the molecule that is produced is also capable of driving a strong immune response.
Birgitte Rønø: Yeah. So EVX-04 is, we have done target discovery, we have selected the lead, and now we are conducting IND-enabling activities. So that includes the GMP manufacturing. And then, of course, we need to check that the molecule that is produced is also capable of driving a strong immune response. And then at the same time, we also engaging with clinical sites, ensuring that we have a setup for testing the EVX-04 molecule. We plan to take this program into the clinic, but we are, of course, always interested and are engaging with companies. So, yeah.
Birgitte Rønø: Yeah. So EVX-04 is, we have done target discovery, we have selected the lead, and now we are conducting IND-enabling activities. So that includes the GMP manufacturing. And then, of course, we need to check that the molecule that is produced is also capable of driving a strong immune response. And then at the same time, we also engaging with clinical sites, ensuring that we have a setup for testing the EVX-04 molecule. We plan to take this program into the clinic, but we are, of course, always interested and are engaging with companies. So, yeah.
Speaker #3: And then, at the same time, we are also engaging with clinical sites, ensuring that we have a setup for testing the EVX04 molecule. We plan to take this program into the clinic, but we are of course always interested in, and are engaging with, companies, so yeah.
Helen Tayton-Martin: Yeah.
Helen Tayton-Martin: Yeah.
Speaker #3: But it's not necessarily dependent on us entering into a partnership.
Birgitte Rønø: But it's not necessarily dependent on us entering into a partnership.
Birgitte Rønø: But it's not necessarily dependent on us entering into a partnership.
Speaker #2: Yeah. And all of those activities are ongoing and on track. So I think in terms of clinical sites, protocol development, GMP production, and compiling the necessary regulatory documentation.
Helen Tayton-Martin: Yeah, and all of those activities are ongoing and on track.
Helen Tayton-Martin: Yeah, and all of those activities are ongoing and on track.
Birgitte Rønø: Yeah, definitely.
Birgitte Rønø: Yeah, definitely.
Helen Tayton-Martin: So I think in terms of clinical sites, protocol development, GMP production, compiling the necessary regulatory documentation, so that contributes to our timeframe that we put out publicly. So no change there, no concern there at the moment.
Helen Tayton-Martin: So I think in terms of clinical sites, protocol development, GMP production, compiling the necessary regulatory documentation, so that contributes to our timeframe that we put out publicly. So no change there, no concern there at the moment.
Speaker #2: So that contributes to our timeframe that we've made public. So no change there—no concern at the moment with all those activities.
Helen Tayton-Martin: No
Birgitte Rønø: No
Helen Tayton-Martin: with all those activities.
Helen Tayton-Martin: with all those activities.
Birgitte Rønø: on track with the communicated timelines of regulatory filings by the end of the year.
Speaker #3: And we're on track with the communicated timelines for regulatory filing by the end of the year.
Birgitte Rønø: on track with the communicated timelines of regulatory filings by the end of the year.
[Analyst] (H.C. Wainwright): Okay. Thank you. I got a couple more questions, one for Helen. So, you and even the previous management have been talking about potential partnerships over a couple of quarters now.
Ramakanth Swayampakula: Okay. Thank you. I got a couple more questions, one for Helen. So, you and even the previous management have been talking about potential partnerships over a couple of quarters now.
Speaker #5: Okay, thank you. I have a couple more questions—one for Helen. So, it's you, and previously even the previous management have been talking about potential partnerships over a couple of quarters now.
Helen Tayton-Martin: Yeah.
Helen Tayton-Martin: Yeah.
[Analyst] (H.C. Wainwright): At this point, what can you tell us in terms of where some of these discussions are? If you would like to characterize the stage of the most advanced ones, where are they at? Are they at the due diligence part, the exploratory part, or you are almost in the hands of the lawyers and waiting for them to get things put into print?
Ramakanth Swayampakula: At this point, what can you tell us in terms of where some of these discussions are? If you would like to characterize the stage of the most advanced ones, where are they at? Are they at the due diligence part, the exploratory part, or you are almost in the hands of the lawyers and waiting for them to get things put into print?
Speaker #5: At this point, what can you tell us in terms of where some of these discussions are? And if you would like to characterize the stage of the most advanced ones, where are they at?
Speaker #5: Are they at the due diligence part, the exploratory part, or are you almost in the hands of the lawyers and waiting for them to get things put into print?
Helen Tayton-Martin: Sure. That is an obvious, it is a good question, RK, but one I cannot really answer as transparently as you would like. I would say in our oncology conversations, obviously clinical data that we have, that Birgitte has talked about, particularly with EVX-01, has been very meaningful. I think to some extent, the validation of the whole field in terms of seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact. I think whilst we have been doing various levels of dialogue and diligence, things have been somewhat, there is sort of a wait to see how the field pans out.
Helen Tayton-Martin: Sure. That is an obvious, it is a good question, RK, but one I cannot really answer as transparently as you would like. I would say in our oncology conversations, obviously clinical data that we have, that Birgitte has talked about, particularly with EVX-01, has been very meaningful. I think to some extent, the validation of the whole field in terms of seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact. I think whilst we have been doing various levels of dialogue and diligence, things have been somewhat, there is sort of a wait to see how the field pans out.
Speaker #2: Sure. So that's an obvious—it's a good question. Okay. But it's one I can't really answer as transparently as you would like. I would say, in our oncology conversations, obviously the clinical data that we have, that Birgitte has talked about, particularly with EVX-01, has been very meaningful.
Speaker #2: But I think that, to some extent, validation of the whole field in terms of seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact.
Speaker #2: So I think whilst we've been doing various levels of dialogue and diligence, things have been somewhat—as there's sort of a wait to see how the field pans out.
Speaker #2: And I think, hence Birgitte's comments earlier about the positive endorsement that this provides for all of us who, I think, have programs that are actually quite differentiated in terms of what they can offer.
Helen Tayton-Martin: Hence Birgitte's comments earlier about the positive endorsement that this provides for all of us who think have programs that are actually quite differentiated in terms of what they can offer and beyond melanoma as well. In amongst all of that, I think that the novelty around the ERV platform, the ability to find the conserved antigens from the dark genome has also piqued quite a bit of interest. Coming in with a second program there in a very difficult to treat brain cancer, accelerates that interest. I have been doing BD for 20-odd years, and things can go very fast when there is motivation and competition, and sometimes it can take 2 years. I would say that we are in active conversations, and obviously, we will be very happy to update when we can.
Helen Tayton-Martin: Hence Birgitte's comments earlier about the positive endorsement that this provides for all of us who think have programs that are actually quite differentiated in terms of what they can offer and beyond melanoma as well. In amongst all of that, I think that the novelty around the ERV platform, the ability to find the conserved antigens from the dark genome has also piqued quite a bit of interest. Coming in with a second program there in a very difficult to treat brain cancer, accelerates that interest. I have been doing BD for 20-odd years, and things can go very fast when there is motivation and competition, and sometimes it can take 2 years. I would say that we are in active conversations, and obviously, we will be very happy to update when we can.
Speaker #2: And beyond melanoma as well. So, in amongst all of that, I think that the novelty around the ERV platform—the ability to find the conserved antigens from the dark genome—has also piqued quite a bit of interest. And coming in with the second program there, in a highly, very difficult-to-treat brain cancer, accelerates that interest.
Speaker #2: So, I've been doing BD for 20-odd years, and things can go very fast when there's motivation and competition. And sometimes, it can take two years.
Speaker #2: So, I would say that we are in active conversations, and obviously, we'll be very happy to update when we can.
Speaker #5: Thank you. One last question from me. So, Thomas, when we look at your operations in the first half, the cash use was about $8.3 million.
[Analyst] (H.C. Wainwright): Thank you. One last question from me. Thomas, when we look at your operations in H1, the cash use was about $8.3 million. It looks like your quarterly burn rate is about $4-plus million. Against the DKK 14 million that you have in the bank now, can you walk us through your assumptions of how to get into H2 2027? Are you expecting cash infusion either organically or inorganically?
Ramakanth Swayampakula: Thank you. One last question from me. Thomas, when we look at your operations in H1, the cash use was about $8.3 million. It looks like your quarterly burn rate is about $4-plus million. Against the DKK 14 million that you have in the bank now, can you walk us through your assumptions of how to get into H2 2027? Are you expecting cash infusion either organically or inorganically?
Speaker #5: And it looks like your quarterly burn rate is about $4 million-plus. So, against the $14 million that you have in the bank now, can you walk us through your assumptions for how to get into the second half of 2027?
Speaker #5: And are you expecting a cash infusion, either organically or non-organically?
Speaker #1: Yeah, yeah. No, good. Thanks. Okay, so maybe to the first part of your question: our cash-out is not linear in the sense that you can just extrapolate it each quarter.
Thomas Frederik Schmidt: Yeah. No, good. Thanks, RK. Maybe first part of your question. Our cash out is not linear in the sense of each quarter just to extrapolate that. Of course, what we have seen and done, in Q2, even in Q1, is not just automatically to be extracted for the full year. There are some differences. Now, we are and will expect to remain on that level that we have communicated also, that said, roughly DKK 14 million for the year. We might, and I would expect to be even slightly lower than that. It is not a round figure as such. We do have, of course, DKK 14 million, as you rightfully have seen on the bank account. Please also do remember, of course, that there are some normal fluctuancies based on we are predominantly a DKK-based company versus the US.
Thomas Schmidt: Yeah. No, good. Thanks, RK. Maybe first part of your question. Our cash out is not linear in the sense of each quarter just to extrapolate that. Of course, what we have seen and done, in Q2, even in Q1, is not just automatically to be extracted for the full year. There are some differences. Now, we are and will expect to remain on that level that we have communicated also, that said, roughly DKK 14 million for the year. We might, and I would expect to be even slightly lower than that. It is not a round figure as such. We do have, of course, DKK 14 million, as you rightfully have seen on the bank account. Please also do remember, of course, that there are some normal fluctuancies based on we are predominantly a DKK-based company versus the US.
Speaker #1: So, of course, what we've seen and done in Q2—even in Q1—isn't just automatically to be extrapolated for the full year. There are some differences.
Speaker #1: Now, we are, and will expect to remain, on that level that we've communicated. Also, that said, roughly $14 million for the year. We might, and I would expect to be, even slightly lower than that.
Speaker #1: So it's not a round figure as such. We do have, of course, 14 million, as you rightfully have seen on the bank account. Please also do remember, of course, that there are some normal fluctuations based on that we are predominantly a DKK-based company versus the US.
Thomas Frederik Schmidt: There are some fluctuations from a pure Forex perspective into that also. On top of that, we still do expect that with the runway and with the focus on where we spend, how we spend, that we still, as mentioned earlier, can confirm that we are in H2 2027. We will, of course, utilize the different things that we have available to us. One is also, not that that has gone in, I should start saying, into the plan in terms of how we've communicated H2 2027, but we do have an ATM facility that we can make use of. Actually, just as of yesterday, we also activated some of that ATM also in the market. Based, of course, on the positive news as we've seen, and the volume in our price.
Speaker #1: So, there are some fluctuations from a pure Forex perspective in that as well. On top of that, we still do expect that, with the runway and with the focus on where we spend and how we spend, as mentioned earlier, we can confirm that we are in the second half of 2027.
Thomas Schmidt: There are some fluctuations from a pure Forex perspective into that also. On top of that, we still do expect that with the runway and with the focus on where we spend, how we spend, that we still, as mentioned earlier, can confirm that we are in H2 2027. We will, of course, utilize the different things that we have available to us. One is also, not that that has gone in, I should start saying, into the plan in terms of how we've communicated H2 2027, but we do have an ATM facility that we can make use of. Actually, just as of yesterday, we also activated some of that ATM also in the market. Based, of course, on the positive news as we've seen, and the volume in our price.
Speaker #1: We will, of course, utilize the different things that we have available to us. One is also not—that has not gone in, I should start saying—into the plan in terms of how we've communicated out to 2027. But we do have an ATM facility that we can make use of.
Speaker #1: And actually, just as of yesterday, we also activated some of that ATM in the market. So, based of course on the positive news we've seen, and the volume in our price.
Thomas Frederik Schmidt: We will make use of those type of possibilities from an ATM perspective. Plus, of course, when we also, at a point in time, announce deals or partnerships, that will certainly also add to it. But with the current straight runway and with our prioritized programs, we are very confident that we will go and get into H2 2027.
Speaker #1: So we will make use of those types of possibilities from an ATM perspective. Plus, of course, when we also, at a point in time, announce deals or partnerships, that will certainly also add to it.
Thomas Schmidt: We will make use of those type of possibilities from an ATM perspective. Plus, of course, when we also, at a point in time, announce deals or partnerships, that will certainly also add to it. But with the current straight runway and with our prioritized programs, we are very confident that we will go and get into H2 2027.
Speaker #1: But with the current straight runway, and with our prioritized programs, we are very confident that we will go and get into the second half of 2027.
Speaker #5: Thank you. Thank you all for taking all the questions.
[Analyst] (H.C. Wainwright): Thank you. Thank you all for taking all my questions.
Ramakanth Swayampakula: Thank you. Thank you all for taking all my questions.
Speaker #2: Thank you.
Helen Tayton-Martin: Thank you.
Helen Tayton-Martin: Thank you.
Speaker #1: Thank you.
Thomas Frederik Schmidt: Thank you.
Thomas Schmidt: Thank you.
Speaker #3: Thank you. We are now going to take our next question. This question comes from Deepanjana Chatterjee from Jones. Please go ahead.
Operator: Thank you. We are now going to take our next question, and this question comes from Debanjana Chatterjee from JonesTrading. Please go ahead.
Operator: Thank you. We are now going to take our next question, and this question comes from Debanjana Chatterjee from JonesTrading. Please go ahead.
[Analyst] (JonesTrading): Hi. Good morning, everyone. This is Avni on for Debanjana. We had a few questions as well. The first one that we wanted to ask was, which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine that you are developing?
[Analyst] (JonesTrading): Hi. Good morning, everyone. This is Avni on for Debanjana. We had a few questions as well. The first one that we wanted to ask was, which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine that you are developing?
Speaker #4: Hi. Good morning, everyone. This is Avni on for Deepanjana. We had a few questions as well. So the first one that we wanted to ask was: Which glioblastoma patients are most likely to benefit from the EVX05 cancer vaccine that you were developing?
Helen Tayton-Martin: We haven't specified a specific population.
Speaker #2: So, we have specified a specific population.
Helen Tayton-Martin: We haven't specified a specific population.
Birgitte Rønø: We are still working on identifying. We're still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal patient populations. Further, we are, of course, also looking into standard of care and combination therapies. One should be a little bit cautious on combining a vaccine with chemotherapy, so there might be an option of going into those patients that are not benefiting from classical chemotherapy treatments. But we haven't entirely settled on the specifics around the clinical trial design.
Birgitte Rønø: We are still working on identifying. We're still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal patient populations. Further, we are, of course, also looking into standard of care and combination therapies. One should be a little bit cautious on combining a vaccine with chemotherapy, so there might be an option of going into those patients that are not benefiting from classical chemotherapy treatments. But we haven't entirely settled on the specifics around the clinical trial design.
Speaker #6: We are still working on identifying, or we are still looking into, different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal set or the most optimal patient population.
Speaker #6: And further, we, of course, are also looking into standard of care and combination therapies, though you'd need to be a little bit cautious when combining a vaccine with chemotherapy.
Speaker #6: So there might be an option of going into those patients that are not benefiting from classical chemotherapy treatments. But we haven't entirely settled on the specifics around the clinical trial design.
Speaker #4: Okay, and then as a quick follow-up: what should we expect as the timeline for initiating that first-in-human clinical trial? And what are some key milestones that investors should be watching for before that trial initiates?
[Analyst] (JonesTrading): Okay. As a quick follow-up, what should we expect as the timeline for initiating that first-in-human clinical trial? What are some key milestones that investors should be watching for before that trial initiates?
[Analyst] (JonesTrading): Okay. As a quick follow-up, what should we expect as the timeline for initiating that first-in-human clinical trial? What are some key milestones that investors should be watching for before that trial initiates?
Speaker #6: Yeah, so we are early in the preclinical development. We've concluded on target discovery, so using our AI immunology for mining the patient data, and now have a set of optimal ERVs that will be included in the EVX05 vaccine.
Birgitte Rønø: Yeah. We are early in the preclinical development. We've concluded on target discovery, so using our AI-Immunology for mining the patient data and now have a set of optimal ERVs that will be included in the EVX-05 vaccine. We are screening. We have designed several different vaccine candidates, are now experimentally testing those to select the lead candidate. Then it's the classical activities, R&D enabling activities, prior to the first-in-human study. As mentioned, we are working together with Duke University. We haven't communicated any firm timelines on this program, as we need to see, first of all, lead selection before we start communicating timelines.
Birgitte Rønø: Yeah. We are early in the preclinical development. We've concluded on target discovery, so using our AI-Immunology for mining the patient data and now have a set of optimal ERVs that will be included in the EVX-05 vaccine. We are screening. We have designed several different vaccine candidates, are now experimentally testing those to select the lead candidate. Then it's the classical activities, R&D enabling activities, prior to the first-in-human study. As mentioned, we are working together with Duke University. We haven't communicated any firm timelines on this program, as we need to see, first of all, lead selection before we start communicating timelines.
Speaker #6: So, we are screening. We have designed several different vaccine candidates and are now experimentally testing those to select the lead candidate. Then it's the classical activities.
Speaker #6: IND activities prior to the first-in-human study. And as mentioned, we are working together with Duke University. We haven't communicated any firm timelines on this program, as we need to see, first of all, lead selection before we start communicating timelines.
Helen Tayton-Martin: We're leveraging the same platform for EVX-04 and EVX-05 in terms of delivery methodology.
Helen Tayton-Martin: We're leveraging the same platform for EVX-04 and EVX-05 in terms of delivery methodology.
Speaker #2: We're leveraging the same platform for EVX04 and EVX05 in terms of delivery methodology, which definitely will, we usually use the expertise and experience there from the GMP production side of things.
Helen Tayton-Martin: Yes.
Birgitte Rønø: Yes.
Helen Tayton-Martin: Which definitely will use the expertise and experience there from the GMP production side of things. More to come on the timelines, but certainly, there is a lot we know about how to bring this kind of platform forward, given the way we have done it already for EVX-04.
Helen Tayton-Martin: Which definitely will use the expertise and experience there from the GMP production side of things. More to come on the timelines, but certainly, there is a lot we know about how to bring this kind of platform forward, given the way we have done it already for EVX-04.
Speaker #2: So more to come on the timelines, but certainly there's a lot we know about how to bring this kind of platform forward, given the way we've done it already for EVX04.
Speaker #4: No, thank you for that color. And then, as a final question—so, beyond glioblastoma, how broadly applicable do you believe the ERV-targeting approach could be across various solid tumors?
[Analyst] (JonesTrading): No, thank you for that color. As a final question, beyond glioblastoma, how broadly applicable do you believe the ERV targeting approach could be across various solid tumors? Broadly, how does the EVX-05 fit into the long-term strategy of building that AI-driven oncology franchise?
[Analyst] (JonesTrading): No, thank you for that color. As a final question, beyond glioblastoma, how broadly applicable do you believe the ERV targeting approach could be across various solid tumors? Broadly, how does the EVX-05 fit into the long-term strategy of building that AI-driven oncology franchise?
Speaker #4: And then, broadly, how does the EVX05 fit into the long-term strategy of building that AI-driven oncology franchise?
Speaker #6: Yeah, so we have worked a lot on using AI in immunology to mine patient data across several different indications. And we do see that there are certain patient subtypes where they have shared ERV antigens.
Birgitte Rønø: Yeah. We have worked a lot in using AI-Immunology to mine patient data across several different indications. We do see that there are certain patient subtypes where they have shared ERV antigens. There is definitely an option of applying this approach more broadly, but it is dependent on the profiles of those indications. But definitely more options for scaling this into other solid tumors and also hematologic malignancies.
Birgitte Rønø: Yeah. We have worked a lot in using AI-Immunology to mine patient data across several different indications. We do see that there are certain patient subtypes where they have shared ERV antigens. There is definitely an option of applying this approach more broadly, but it is dependent on the profiles of those indications. But definitely more options for scaling this into other solid tumors and also hematologic malignancies.
Speaker #6: So there's definitely an option of applying this approach more broadly, but it's dependent on the profiles of those indications. But there are definitely more options for scaling this into other solid tumors, and also hematologic malignancies.
Helen Tayton-Martin: I think what is interesting is that often where there is not a high mutational burden, there often is a high ERV frequency, and that is what we have been looking into. Often where there is not an opportunity to take a personalized approach forward because of low mutational burden, that does not seem to be the case with the ERVs. More to come on that as we have been teasing this up. We think it really does broaden out the opportunity in terms of the cancer vaccine approach for novel targets.
Speaker #2: And I think what's interesting is that often, where there's not a high mutational burden, there often is a high ERV frequency. And that's what we've been looking into.
Helen Tayton-Martin: I think what is interesting is that often where there is not a high mutational burden, there often is a high ERV frequency, and that is what we have been looking into. Often where there is not an opportunity to take a personalized approach forward because of low mutational burden, that does not seem to be the case with the ERVs. More to come on that as we have been teasing this up. We think it really does broaden out the opportunity in terms of the cancer vaccine approach for novel targets.
Speaker #2: So often, where there isn't an opportunity to take a personalized approach forward because of low mutational burden, that doesn't seem to be the case with the ERVs.
Speaker #2: And so, more to come on that as we've been teasing this apart. We think it really does broaden out the opportunity in terms of what we—the cancer vaccine approach—for novel targets.
Speaker #4: Thank you. Exciting times ahead. I appreciate you taking my questions.
[Analyst] (JonesTrading): Thank you. Exciting times ahead. I appreciate you taking my questions.
[Analyst] (JonesTrading): Thank you. Exciting times ahead. I appreciate you taking my questions.
Speaker #2: Thank you.
Helen Tayton-Martin: Thank you.
Helen Tayton-Martin: Thank you.
Speaker #3: 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.
Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone. That is star 1 and 1 to ask a question. There seems to be no further questions for today, so I will hand the call back to Helen for closing remarks.
Operator: Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone. That is star 1 and 1 to ask a question. There seems to be no further questions for today, so I will hand the call back to Helen for closing remarks.
Speaker #3: There seem to be no further questions for today, so I will hand the call back to Helen for closing remarks.
Helen Tayton-Martin: Thank you. Thank you, everyone, for listening in today and for the excellent questions that we've had. We're really excited about the operational momentum that we've been able to deliver, about the interest in the programs coming in on the back of a really exciting time for personalized cancer vaccines in the whole field. Exciting things to come, and we look forward to updating you further in the H2 of the year. Thank you.
Helen Tayton-Martin: Thank you. Thank you, everyone, for listening in today and for the excellent questions that we've had. We're really excited about the operational momentum that we've been able to deliver, about the interest in the programs coming in on the back of a really exciting time for personalized cancer vaccines in the whole field. Exciting things to come, and we look forward to updating you further in the H2 of the year. Thank you.
Speaker #6: Thank you. And thank you, everyone, for listening in today and for the excellent questions that we've had. We're really excited about the operational momentum that we've been able to deliver and about the interest in the programs.
Speaker #6: Coming in on the back of a really exciting time for personalized cancer vaccines and the whole field. So, exciting things to come, and we look forward to updating you further in the second half of the year.
Speaker #6: Thank you.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
