Q2 2024 Evaxion Biotech AS Earnings Call
Good day and thank you for standing by. Welcome to the Evaxium Biotech Business Update Conference Call.
Operator: I'm a participant, and I listen only to my... After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising that your hand is raised.
Speaker Change: At this time all participants are in a listen-only mode. After the speaker's presentation there will be a question and answer session.
Speaker Change: To ask a question during this session, you will need to press star 1, 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1, 1 again. Please be advised that today's conference is being recorded.
Operator: To withdraw your question, please press star 1 1 again. Today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Christian Kanstrup, CEO. Please go ahead.
Speaker Change: I would now like to hand the conference over to your first speaker today, Christian Kanstrup, CEO . Please go ahead.
Christian Kanstrup: Good morning and good afternoon, everyone, and a very warm welcome to this Evaxion Business Update conference call on the back of our Q2 results. I'm Christian Kanstrup, CEO of Evaxion. With me today are Birgitte Rono, our CSO, and Jesper Nygaard Nissen, our COO and CFO.
Christian Kanstrup: Good morning and good afternoon everyone and a very warm welcome to this Evaction Business Update conference call on the back of our Q2 results.
Christian Kanstrup: I'm Christian Kanstrup, CEO of Fibaction.
Speaker Change: With me today, I have Birgitte Rono, our CSO, I have Jesper Nygaard Nissen, our COO and CFO.
Christian Kanstrup: And I also have a new joiner with me today, which is Mads Kronborg, VP of Investor Relations and Communication. And I would actually like just to start out handing briefly over to Mads for a brief introduction to who you are, as this is the first time you are joining the call here.
Speaker Change: And I also have a new joiner with me today, which is Mads Kronborg, VP Investor Relations and Communication. And I would actually like just to start out handing briefly over to Mads for a brief introduction to who you are. This is the first time you are attending the call here.
Mads Kronborg: Thank you, Christian, and thank you for the opportunity. And just for a brief introduction, I have some 15 years of experience in corporate humiliation and investor relations in the pharmaceutical and biotech industries, having early held positions like head of corporate humiliation at Lundbeck and head of IR and communication at Zealand. And just for a brief introduction, I have some 15 years of experience in corporate humiliation at Lundbeck. I'm glad to join Evaxion at this very interesting time for the company with a number of milestones lying ahead.
Mass Chromebook: Thank you Christian and thank you for the opportunity. And just for a brief introduction, I have some 15 years of experience in corporate communication and investor relations from the pharmaceutical and biotech industries, having earlier held positions like head of corporate communication at Lundbeck and head of IRN communication at Zeeland Pharma.
Mads Kronborg: And I'm looking forward to helping communicate our progress and facilitate the dialogue with you as investors, analysts, and journalists. You will find my contact information in the investors section of our website and are, of course, always welcome to get in touch.
Speaker Change: I'm glad to join the vaccine at this very interesting time for the company with a number of milestones lying ahead And I'm looking forward to help communicate our progress and facilitate the dialogue with you as investors analysts and journalists
Christian Kanstrup: And I am pleased to have Mads on board so we can provide even better service and support to all of you. So, great to have you on board, Mads. Now, let's jump to the next slide and look at the agenda for today. I'm going to do a brief introduction, then I'll hand over to Birgitte for an R&D business update, and Jesper will be covering our financial results.
Speaker Change: You will find my contact information on the investors section of our website and are of course always welcome to get in touch.
Mass Chromebook: And I am pleased to have MASS on board so we can provide even better service and support to all of you. So great to have you on board, MASS.
Speaker Change: Then let's jump to the next slide and look at the agenda for today. I'm going to do a brief introduction, then I'll hand over to Birgitte.
Christian Kanstrup: I will conclude before we head into the Q&A. But before we get going, for real, let's just direct our attention to slide three, which is forward-looking statements. As you know, we will be talking about the future, and that does entail uncertainty. Hence, please read this one carefully.
Birgitte Rono: for an R&D business update.
Birgitte Rono: Jesper will be covering our financial results, I will conclude before we head into the Q&A part.
Christian Kanstrup: So with that, let's look at some of the key achievements since our last business update. As you know, one of the key elements in our strategy is to create value via multi-part. However, we do not know proof.
Birgitte Rono: But before we get going for real, let's just direct our attention to slide three, which is forward-looking statements. As you know, we will be talking about the future, and that do entail uncertainty. Hence, please read this one carefully. So with that...
Birgitte Rono: Let's look at some of the key achievements since last business update. As you know, one of the key elements in our strategy is to create value via a multi-partner approach.
Christian Kanstrup: And here I'm super pleased to see that we have been advancing our partnering discussions. Since our last update, we're seeing a solid interest from external parties, both in our AI platform and pipeline candidates. And we do have several partnership discussions ongoing.
Birgitte Rono: And here I'm super pleased to see that we have been advancing our partnering discussions since our last update. We're seeing a solid interest from external parties, both in our AI immunology platform and pipeline candidates. And we do have...
Christian Kanstrup: And this is, of course, key to executing upon our multi-partner strategy that we see these discussions advancing. What I'm also pleased about is that we are seeing progress on the EVX01 program. We presented positive and validating phase two immune data at ASCO this year. We also presented our phase one results in a leading medical journal, including the 67% objective response rate from the phase one trial, which I'm very proud about. And very importantly, we are on track for a key milestone for Evaxion, our one-year clinical data readout, which will be presented at the ESMO Congress in September. So, very nice progress on the EVX01 program.
Birgitte Rono: several partnerships discussions ongoing and this is of course key to execute upon our multi-partner strategy that we see these discussions advancing.
Birgitte Rono: What I'm also pleased about is that we are seeing progress on the EBX-01 program.
Birgitte Rono: We did present positive and validating phase 2 immune data at ASCO this year. We also presented our
Birgitte Rono: Phase 1 results in a leading medical journal.
Birgitte Rono: including
Birgitte Rono: including the 67% objective response rate from the Phase 1 trial, which I'm very proud about.
Birgitte Rono: And very importantly, we are on track for a key milestone for Evaction, our one-year clinical data readout, which will be presented at the ESMO Congress in September. So, very nice progress on the EVX01 program.
Christian Kanstrup: In addition to this, an important element is, of course, to continue strengthening our AI immunology platform and our capabilities, which we have also progressed on over the past quarter. Among other things, we did get positive feedback on a patent application for an AI-based novel target identification method that is based on endogenous retroviruses. And, of course, creating a strong IP portfolio around our platform and around our pipeline assets is important for us.
Birgitte Rono: In addition to this, an important element is, of course, to continue strengthening our AI immunology platform and our capabilities, and that we have also progressed upon over the past quarter.
Birgitte Rono: Among other things, we did get the positive feedback on a patent application for an AI-based novel target identification method, which is based on the endogenous retroviruses. And of course,
Christian Kanstrup: So getting this positive feedback is a major milestone for the continued strengthening of our platform. Finally, I think it is worth mentioning the fact that we presented at the Computational Biology Conference not too long ago an improved performance of one of the building blocks of AI immunology. And as you might remember, AI even has a quite unique modular structure where we have a number of building blocks used across the different AI models.
Birgitte Rono: Creating a strong IP portfolio around our platform and around our pipeline assets is important for us. So getting this positive feedback is a major milestone for the continued strengthening of our platform.
Birgitte Rono: Finally, I think worth mentioning is the fact that we did present at the computational biology conference not too long ago an improved performance of one of the building blocks of AI immunology.
Christian Kanstrup: And that means improving the performance of one of these will improve the performance of those AI models where it's used. So we have the opportunity of showcasing what we do to increase the predictive capabilities, which we will get back to later. This is a major element in strengthening and improving our AI humanity platform. So I would say it has been quite busy with several important parts of our strategy as we advance since our last update.
Birgitte Rono: And as you might remember then, AI immunology has a quite unique modular structure where we have a number of building blocks used across
Birgitte Rono: the different AI models, and that means improving the performance of one of these.
Birgitte Rono: will improve the performance of those AI models where it's used. So having the opportunity of...
Birgitte Rono: showcasing what we do to increase the predictive capabilities, which we'll get back to later, is a major element in strengthening and improving our AI immunology platform.
Birgitte Rono: So I would say it has been quite busy with several important parts of our strategy advancing since our last update.
Christian Kanstrup: And I would also just on the next slide, quickly recap on our strategy, our strategy is unchanged. As you know, we have a three-pronged business model which is based upon AI Immunology So the core, the core of our strategy that AI Immunology and then we have the multi-partner approach towards value realisation [inaudible] AI Immunology and then we have the core of AI Immunology, Then the three prongs, its targets, its pipeline, and its responders within the target park that is about a multi-partner approach focusing around either single or multiple vaccine target discovery, design and development agreements.
Birgitte Rono: And I would also just on the next slide quickly recap on our strategy. Our strategy is unchanged.
Birgitte Rono: As you know, we have a three-pronged business model, which is based upon AI immunology. So the core of our strategy, that's AI immunology, and then we have the multi-partner approach towards value realization.
Christian Kanstrup: And of course, the collaboration we have with MSD around EVXB3 is a great example of what we want to achieve here, a pipeline that's taking select high-value programs forward by bringing these two key value infection points. And again, that's why we are super excited about having the readout of the one-year clinical data from phase two on EVX01 in September at the ESMO conference. This is going to be a key milestone for evaction.
Birgitte Rono: Then the three prongs, its targets.
Birgitte Rono: it's pipeline and it's responders. Within the target path, that is about a multi-partner approach focusing around either single or multilateral partners.
Birgitte Rono: on Multiple Vaccine Type Discovery, Design and Development Agreements.
Birgitte Rono: And of course the collaboration we have with MSD around EVX B3 is a great example of what we want to achieve here. Pipeline that's taking select
Birgitte Rono: high-value programs forward ourselves, bringing these to key value inflection points.
Birgitte Rono: And again, that's why we are super excited about having the readout of the one-year clinical data from the Phase II on EBX-01 in September at the ESMO conference.
Christian Kanstrup: Finally, the responder part, that's really about taking the core capabilities we have data, predictive analysis, and developing responder models. So, the three-pronged business model remains in place, the multi-partner approach to what the value of realisation is, And then, before handing over to Birgitte, I just want to look a little bit forward because we have a number of important milestones to report shortly. In September, at the ECCB conference, we will be launching the upgraded version of Eden Model 5, or version 5.0, which we are looking very much forward to.
Birgitte Rono: This is going to be a key milestone for evacuation. Finally, the responder part, that's really about taking the core capabilities we have, data, predictive analysis, and developing responder models.
Speaker Change: So three-pronged business model remains in place, multi-partner approach towards value realization.
Speaker Change: And then before handing over to Birgitte, I just want to look a little bit forward because we have a number of important milestones to report shortly.
Birgitte Rono: In September , at the ECCB conference, we will be launching the upgraded version of Eden version 5.0 that we are looking very much forward to, and that of course links into the continuous strengthening of our AI immunology platform.
Christian Kanstrup: And that, of course, links into the continuous strengthening of our AI immunology platform. Also, in September, at the 18th Vaccine Congress, we will be reporting out on the milestone for EVXB2 in an mRNA version, where we have been pursuing preclinical proof of concept. I already mentioned ESMO, September, the one-year readout on EVX-01.
Birgitte Rono: Also in September, at the 18th Vaccine Congress, we will be reporting out on the milestone for EVXB2 in an mRNA version, where we have been pursuing preclinical proof of concept.
Christian Kanstrup: So a number of important milestones are reporting out shortly. For the latter part of the year, we are still on track with our collaboration with MSD around EVX-B3, where the first phase is going to conclude in the second half. We are on track with our Earth-based...
Birgitte Rono: I already mentioned ESMO, September , one year readout on EVX01.
Birgitte Rono: So, a number of important milestones reporting out shortly. For the latter part of the year, we are still on track with our collaboration with MSD around EVX B3, where the first phase is going to conclude in the second half. We are on track with our Earth-based...
Christian Kanstrup: Precision Cancer Vaccine, where we are pursuing the preclinical proof of concept that we'll also report out later in the year. And then finally, we have the ambition of generating business development income equal to our 2024 cash burn, excluding financing activities. That also remains.
Birgitte Rono: Persistent Cancer Vaccine where we are pursuing the preclinical proof of concept that will also be brought out later on in the year.
Birgitte Rono: And then finally, we have the ambition of generating business development income equal to our 2024 cash burn excluding financing activities. That also remains.
Christian Kanstrup: The only thing here is that the attentive reader will see we have updated this wording here to say business development income or cash in, and that reflects the fact that, of course, now we are relatively late in the year, hence if we get to the 14 million, it's uncertain if the accounting impact of the upfront milestone will lead to full accounting for this in this year or that will be leading into next year, so from an income point of view, it might be But, as you of course know, any business development activity is uncertain, so this remains an ambition.
Speaker Change: The only thing here is the attentive reader will see we have updated this wording here to say business development income or cash in and that reflects the fact that of course now we are relatively
Speaker Change: later on in the year, hence, if we get to the 14 million
Speaker Change: It is uncertain if the accounting impact of Upfront Milestone will lead to full accounting for this in this year, or that will be leading into next year. So from an income point of view, it might be divided over 24 and 25. But from a cash point of view, we clearly have the ambition which remains intact of generating a business development income of 14 million.
Christian Kanstrup: But, as I also started out saying, we are seeing very nice traction on our business development activities with several discussions ongoing. I am also pleased to say that we are seeing new potential partners approaching us on a regular basis. So, strong activity around our business development activities, and we have the ambition of generating 14 million this year. But, of course, uncertainty remains. And with that, I will hand over to Birgitte to give an update on the exciting R&D activities that have taken place over the past quarter. Thank you, Christian.
Speaker Change: But as you of course know, any business development activity is uncertain, so this remains an ambition.
Speaker Change: But as I also started out saying, we are seeing a very nice traction.
Speaker Change: on our business development activities with several discussions ongoing.
Speaker Change: Also pleased to say that we are seeing new potential partners.
Speaker Change: approaching us on a regular basis.
Speaker Change: So, strong activity around our business development activities and we are having the ambition of generating the 14 million this year, but of course, uncertainty remains.
Speaker Change: And with that, I will hand over to Birgitte for giving an update on the exciting R&D activities that have taken place over the past quarter.
Birgitte Rono: It has been a very active and busy time during the last quarter, and today I will focus on the data from the phase two study of EVX01 presented at FGO in June and on the improvement in this central building block in our AI platform, but we call it X in C, and that building block is key for designing effective vaccines. The performance of this building block was presented at a computational biology conference called Intelligent Systems for Molecular Biology in July.
Begitte: Thank you, Christian. It has indeed been a very active and busy time during the last quarter, and today I will focus on the data from the Phase 2 study of EVX01.
Speaker Change: presented at ESCO in June and on the improvement on this central building block in our AI technology platform that we call Evax-MSC.
Speaker Change: And that building block is key for designing effective vaccines.
Speaker Change: The performance of this building block was presented at the Computational Biology Conference called Intelligent Systems for Molecular Biology in July.
Birgitte Rono: So our EVX01 lead product candidate is a personalized cancer vaccine designed to engage the patient's own immune system to fight the cancer, and Evax01 is currently in phase 2 in a global multi-center trial in first-line advanced melanoma. So the patients enrolled in the Phase II trial received standard of care, that is, the checkpoint inhibitor from MSD called Ketuda, and they received it according to label in combination with six initial EVX-1 priming doses, followed by four additional boosts of dose. [inaudible] So EVX01 consists of 10 AI immunology-identified neoantigens, and neoantigens are these short sequences that are exclusively found in tumors.
Speaker Change: So our EVX01 lead product candidate is a personalized cancer vaccine designed to engage the patient's own immune system to fight the cancer.
Speaker Change: Evax01 is currently in phase 2 in a global multi-center trial in first-line advanced melanoma.
Speaker Change: So the patients involved in the Phase 2 trial received standard of care.
Speaker Change: that is the checkpoint inhibitor from MSD called Ketruda and they receive it according to label in combination with 6 initial EVH01 priming doses following by 4 additional booster doses.
Speaker Change: Evax01 consists of 10 AI immunology identified neoantigens, and neoantigens are these short sequences that are exclusively found in tumors.
Birgitte Rono: And when administered to a patient, they will induce a specific T cell response with tumor-killing potential. So in June, we presented encouraging immunodata from the first 12 patients at ESO. And what the data demonstrated was that we could find Evaxion, one in Jerusalem, responses in all of these evaluated patients. And the graph to the right displays the EVX01-induced immune response over time. Week 1 represents baseline, when the patients have not received any study therapy.
Speaker Change: and when administered to a patient, they will induce a specific T-cell response with a tumor-killing potential.
Speaker Change: In June, we presented encouraging immune data from the first 12 patients.
Speaker Change: at ESSO. And what the data demonstrated was that we could find EVXO1-induced T-cell responses in all of these evaluated patients.
Speaker Change: And the graph to the right displays the EVX01-induced immune response over time.
Birgitte Rono: Week 12 is when the patients have been dosed with Keytruda, and at week 18, that is during the EVX01 priming phase, whereas week 30, that is after priming or before the patient has received any booster immunization. So in all evaluated patients, we do see an increase in the T cell response upon vaccination with dbHR1. Furthermore, further analysis also demonstrated that the T-cell responses were mediated by CD4+ T cells and CD8+ T-cell responses.
Speaker Change: Week 1 represents baseline where the patient has not received any study therapy.
Speaker Change: Week 12 is where the patients have been dosed with Ketuta.
Speaker Change: and at week 18, that is during the EVH01 priming phase, whereas week 30, that is after priming, but before the patient has received any booster immunization.
Speaker Change: So in all evaluated patients, we do see an increase in the T-cell response upon vaccination with PBXO1.
Birgitte Rono: I have not included the data here, but they were presented at ESCO, and there is currently a lot of debate about the roles of CD8s and CD4s, and we have also, Yeah, I've talked a lot about this, and we believe that it's very important that there is a balance between these two types of cells. We also saw that upon boosting, we could maintain the response in the patient, and we believe that this is critical for obtaining a doable clinical response. What is also important is to look at individual neoantigens and their ability to induce a specific immune response.
Speaker Change: So further analysis also demonstrated that the T cell responses were mediated by CD4 and CD8 T cell responses.
Speaker Change: I have not included the data here, but they were presented at ESCO and...
Speaker Change: There is currently a lot of debate about the roles of CD8s and CD4s, and we have also...
Speaker Change: They have talked a lot about this and we believe that it is very important that there is a balance between these two keystone types.
Speaker Change: We also saw that upon boosting we could maintain the response in the patient and we believe that this is critical for obtaining a doable clinical response.
Speaker Change: What is also important is to look at the single mu antigens and their ability to induce a specific immune response.
Birgitte Rono: And the graph to the left depicts also the response to the individual new antigens in the vaccine over time. And at week 30, we could see that we had... 64 out of the administered 90 antigens giving rise to a specific immune response, leading us to 71% out of church hits. And that we believe also compares favorably to what we have seen other people communicating. And that we are communicating. Moreover, we correlated the AI immunology prediction scores and the new antigen T cell responses, and that is depicted in the graph to the right.
Speaker Change: And the graph to the left depicts also the response to the individual new antigens in the vaccine over time. And at week 30, we could see that we had
Speaker Change: 64 out of
Speaker Change: The administered 90 antigens giving rise to a specific immune response, leaving us with 71% positive hits.
Speaker Change: And that, we believe, also compares favorably to what we have seen others communicating.
Speaker Change: Moreover, we correlated the AI immunology prediction scores and the new antigen T-cell responses.
Speaker Change: And that is depicted on the graph to the right, and that demonstrated a significant positive correlation, also underlining the precision and predictive power of our AI immunology platform.
Birgitte Rono: And that demonstrated a significant positive correlation, also underlining the precision and predictive power of our AI immunology test. So just to summarize... Evaxion, The ESCO data demonstrated EVX01-induced T-cell responses in all 12 patients. The responses were mediated predominantly by CD4 T-cells but also by CD8 T-cells.
Speaker Change: So, just to summarize.
Speaker Change: Em.
Speaker Change: The ASCO data we demonstrated EVX01-induced T-cell responses in all 12 patients. The responses were mediated predominantly by CD4 T-cells but also by CD8 T-cells.
Birgitte Rono: We saw that 71% of the new antigens induced an immune response, and AI immunology's new antigen quality score correlated with immune response. And in general, we believe that these early immune data are very encouraging, and we are looking so much forward to presenting the one-year clinical readout at Esmeralyn in September, as Christian alluded to. So changing focus a little bit, we are continuously working on improving our AI immunology platform, and one key feature in developing the effects of the vaccine is the ability to actively predict these small fragments, known as pet sites, stemming from pathogens and cancers that are displayed on the surface also. And this allows the immune system to recognize and eliminate the threat.
Speaker Change: We saw that 71% of the new antigens induced an immune response and AI immunology new antigen quality score correlated with immune responses.
Speaker Change: In general, we believe that these early immune data are very encouraging and we are looking so much forward to presenting the one-year clinical readout at ESMO in September as Christian alluded to.
Speaker Change: Changing focus a little bit, we are continuously working on improving our AI immunology platform.
Speaker Change: And one key feature is...
Speaker Change: In developing effective vaccine is the ability to accurately predict these small fragments known as peptides stemming from pathogens and cancer cells that are displayed on the surface of cells.
Speaker Change: and this allows the immune system to recognize and eliminate the threat.
Birgitte Rono: N N N, So we have worked on one of these key building blocks in AI immunology is one called EvaxMHC, and it actually predicts which peptides are most likely to be displayed on the surface of cells and thereby the most clinically relevant vaccine targets. So with this improvement, we have used state-of-the-art novel deep learning framework work, and we have also trained the models on publicly and proprietary data. We saw that when we compared to publicly available tools, there was an improved performance of this building block.
Speaker Change: And,
Speaker Change: So we have worked on a
Speaker Change: Improving one of these key building blocks in AI immunology is a one called EvaxMHC, and that actually predicts which peptides that are most likely to be displayed on the surface of cells and thereby the most putically relevant vaccine targets.
Speaker Change: Rono, Jesper Nissen, Christian Kanstrup,
Speaker Change: With this improvement, we have used state-of-the-art novel deep learning framework and we have also trained the models on publicly and proprietary data.
Speaker Change: And we saw that when we compared to publicly available tools, there was an improved performance of this building block.
Birgitte Rono: So with these improvements, we anticipate further enhancement of the ability to accurately predict vaccine targets, and we also anticipate that these updated versions of Evaxion C will lead to an improved design of our vaccines. So just to sum up, in June, at ESCO, we presented encouraging new data from our EVX01 phase 2 cancer study, and we are on track for this exciting upcoming one-year data presentation at ESMO. Further, we have shown with this improved performance of our key building plus that we can potentially improve the design for cancer and infectious diseases.
Speaker Change: So with these improvements, we anticipate to further enhance the ability to accurately predict vaccine targets.
Speaker Change: And we also envision that these updated versions of Evax and E.C. will lead to an improved design of our vaccines.
Speaker Change: So just to sum up, in June at ESCO we presented encouraging new data from our EVH01 Phase 2 cancer study.
Speaker Change: And we are on track for this exciting upcoming one-year data presentation at ESMO.
Speaker Change: Further, we have shown with this improved performance of our key building blocks that we potentially can improve the design of both cancer and infectious disease vaccines.
Birgitte Rono: Thank you, Birgitte. I think it's fair to say it's truly exciting to see the Evaxion One Data continuing to unfold, so looking forward to September and now to you, yes, but to see how the Q2 numbers have unfolded. Thank you, Christian.
Jesper Nissen: Thank you Birgitte, I think it's fair to say, truly exciting to see the EVX01 data continuing to unfold, so looking forward to September . And now over to you Jesper to see how the Q2 numbers have been unfolding.
Jesper Nissen: I will focus my comments on the financial results for the first half year of 2024 compared to the first half year of 2023. All the numbers that I will review will be approximate for easy sharing during the call. For additional information regarding our first half-year results and period comparisons, please refer to the business update and second quarter 2024 financial results press release and the Form 6 case we filed this morning.
Jesper Nissen: Thank you, Christian. I will focus my comments on the financial results for the first half year of 2024 compared to the first half year of 2023.
Jesper Nissen: All the numbers that I will review will be approximate for easy sharing during the call.
Jesper Nissen: For additional information regarding our first half-year results and period comparisons, please refer to the business update and second quarter 2024 financial results press release and the Form 6 case we have filed this morning.
Jesper Nissen: Starting with our financial highlights for the first half of 2024, we are seeing the effects of the 2023 cash spend optimization and organizational slimming in the financial results. This is linked to the continued implementation of the focus company strategy with intensified focus on value realization via partnering, as we shared earlier. As of June 30, 2024, cash and cash equivalents were USD 8 million.
Jesper Nissen: Starting with our financial highlights for the first half year of 2024, then we are seeing the effects of the 2023 cash spend optimization and organizational slimming in the financial results.
Jesper Nissen: This is linked to the continued implementation of the Focused Company Strategy with intensified focus on value realisation via partnering, as we shared at prior calls.
Jesper Nissen: We expect that our existing cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into February 2025. If all pre-funded warrants included in the public offering in February 2024 are exercised, we expect the necessary funding will be in place into March 2024. As shared earlier, the company received a Nasdaq Equity Deficiency Letter on May 7, 2024, as a result of our equity being below 2.5 million.
Jesper Nissen: As of June 30, 2024, cash and cash equivalents were USD 8 million.
Jesper Nissen: We expect that our existing cash and cash equivalents will be sufficient to fund our operation expenses and capital expenditure requirements.
Jesper Nissen: into February 2025.
Jesper Nissen: If all pre-funded warrants included in the public offering in February 2024 are exercised, we expect necessary funding will be in place into March 2025.
Speaker Change: Rono, Jesper Nissen,
Speaker Change: As shared earlier, the company received May 7, 2024, a Nasdaq Equity Deficiency Letter as a result of our equity being below $2.5 million.
Jesper Nissen: A plan to regain compliance has been shared with and accepted by NASDAQ, giving the company until November 4, 2024, to demonstrate compliance. Looking at our expenses for the period, research and development expenses were 5.6 million for the six months ended June 30, 2024. The decrease of 1.2 million versus the same period in 2023 was primarily due to a decrease in employee-related costs, a counterbalanced by a smaller increase in costs related to clinical trials. General and administrative expenses were 3.6 million for the six months ended June 30.
Speaker Change: A plan to regain compliance has been shared with and accepted by NASDAQ, providing the company until November 4, 2024 to evidence compliance.
Speaker Change: Looking at our expenses for the period, research and development expenses were 5.6 million for the six months ended June 30, 2024.
Speaker Change: The decrease of 1.2 million versus the same period in 2023 was primarily due to a decrease in employee-related costs counterbalanced by
Speaker Change: by a smaller increase in cost related to clinical trials.
Jesper Nissen: The decrease of 1.7 million versus the same period in 2023 was primarily due to reduced external costs related to professional fees, as well as reduced employee costs for the period. Finance income and expenses for the first six months of 2024 are primarily impacted by effects from the remissionment of the derivative liability related to investor ones from the public offering in February 2024 as well as the private placement in December 20th. These effects have been eliminated going forward as the investor wants the exercise currency change from the USD to DKK during Q2, moving them from being recognized as financial instruments to equity instruments.
Speaker Change: General and administrative expenses were $3.6 million for the six months ended June 30.
Speaker Change: The decrease of 1.7 million versus the same period in 2023 was primarily due to reduced external costs related to professional fees as well as reduced employee costs for the period.
Operator: I'm a participant and I listen only mode. After the speaker's presentation there'll be a question and answer session. To ask a question during this session you will need to press star one, one on your telephone, nor then hear an automated message advising your hand is raised.
Speaker Change: Finance income and expenses for the first six months of 2024 are primarily impacted by effects from the remeasurement of the derivative liability related to investor warrants from the public offering in February 2024, as well as the private placement in December 2023.
Operator: To withdraw your question please press star one, one again.
Operator: Please be advised that today's conference is being recorded.
Operator: I would now like to hand the conference over to your first speaker today.
Speaker Change: These effects have been eliminated going forward as the investor wants have had the exercise currency change from the USD to DKK during Q2, moving them from being recognized as financial instruments to equity instruments.
Christian Kanstrup: Christian Kanstrup, CEO please go ahead. Good morning and good afternoon. Good afternoon everyone and a very warm welcome to this evaction business update conference call on the back of our Q2 results. I'm Christian Kanstrup, CEO of evaction. With me today I have Birgitte Rune, our CEO, I have Jesper Nguyen Garde Nissen, our CEO and CFO.
Jesper Nissen: And with that, I would like to turn back to you, Christian, for a few concluding remarks before the Q&A. Thank you so much, Jesper, and thanks for the update on the numbers. Let me just quickly..., make a few concluding remarks before we jump into the Q&A part.
Speaker Change: And with this, I would like to turn back to you, Christian, for a few conclusive remarks before the Q&A. Thank you so much, Jesper, and thanks for the update on the numbers. Let me just quickly ...
Mads Kronborg: And I also have a new joiner with me today, which is Mads Kronborg, VP in Best of Relations and Communication.
Christian Kanstrup: I think it's fair to say that we are seeing solid progress on our three-pronged business model and very good traction along the different paths. Importantly, also, we are having a strong focus on advancing ongoing business development discussions, which of course is a key milestone for us this year as well, and we will be focusing on value generation via a multi-partner approach. Again, the data Birgitte presented shows that EVX01 continues to deliver solid data, and we do have a major milestone coming up here at ESMO in September.
Christian Kanstrup: provide a few conclusive remarks before we jump into the Q&A part.
Mads Kronborg: And I would actually like to just start out handing briefly over to Mads for a brief introduction to who you are. This is the first time you are attending the call here. Thank you, Christian and thank you for the opportunity. And just for a brief introduction I have some 15 years of experience in corporate communication and investor relations from the pharmaceutical and bioseg industries having early held positions like head of corporate communication at Lundbeck and head of IR and communication at Ceylon Farmers.
Christian Kanstrup: I think it's fair to say that we are seeing a solid progress on our three-pronged business model and very good traction along the different paths.
Christian Kanstrup: Importantly also we are having a strong focus on advancing ongoing
Speaker Change: Business Development Discussions, which of course is a
Speaker Change: key milestone for us this year as well, that we will be focusing on value generation via a multi-partner approach.
Mads Kronborg: I'm glad to join the action at this very interesting time for the company with a number of milestones laying ahead. And I'm looking forward to help communicate our progress and facilitate the dialogue with you as investors, analysts and journalists. You will find my contact information on the investor section of our website and are of course always welcome to get in touch.
Speaker Change: Again, the data Birgitte presented shows that EVX01 continues to deliver solid data and we do have a major milestone coming up here at ESMO in September .
Christian Kanstrup: And in addition to that, it is going to be a busy time ahead with several of our other 2024 milestones going to be reported out, just as we are on track for delivering on remaining milestones during the second half of the year. So all in all, I would say I'm very pleased with the progress we are seeing, a strong focus on execution and bringing our strategy forward.
Christian Kanstrup: Mad, I am pleased to have Mads on board so we can provide even better service and support to all of you. So great to have you on board, Mads.
Speaker Change: And in addition to that, it is going to be a busy time ahead with several of our other 2024 milestones going to report out, just as we are on track for delivering on the remaining milestones during the second half of the year.
Christian Kanstrup: Then let's jump to the next slide and look at the agenda for today. I'm going to do a brief introduction.
Birgitte Rune: Then I'll hand over to Brigitte for an R&D business update.
Speaker Change: So all in all, I would say I am very pleased with the progress we are seeing and strong focus upon.
Jesper Nissen: Jesper will be covering our financial results. I will conclude before we head into the Q&A path.
Christian Kanstrup: So with that, I would very much like to open up for the Q&A session. So please, just join the Q&A session. Thank you. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question, please press star 11 again. We will now take our first question. Please stand by. And the first question comes from the line of Leighton from HC Wainwright: please go ahead, your line is now open. Hey D. Hi Christian.
Speaker Change: execution
Christian Kanstrup: But before we get going for real, let's just direct our attention to slide three, which is forward looking statements. As you know, we will be talking about the future and that do entail uncertainty.
Speaker Change: and bringing our strategy forward. So, with that, I would very much like to open up for the Q&A session. So, please...
Speaker Change: just join the Q&A session.
Christian Kanstrup: Hence, please read this one carefully. So with that, let's look at some of the key achievements since last business update. As you know, one of the key elements in our strategy is to create value via multi partner approach. And here I'm super pleased to see that we have been advancing our partnering discussions since our last update. We're seeing a solid interest from external parties, both in our AI, you know, the platform and pipeline candidates.
Speaker Change: Thank you. As a reminder to ask a question you will need to press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question please press star 1 1 again. We will now take our first question. Please stand by.
Unknown Attendee: Congratulations on this great quarter. I have a couple of questions first. Do we expect any updates between them? I have more data and the final data in 2025 in regards to EVX01. I can answer that very highly.
Speaker Change: And the first question comes from the line of Leighton from HC Wainwright. Please go ahead, your line is now open.
Speaker Change: Hello everyone. Hi Christian. Congratulations on this great quarter. I have a couple of questions. First, do we expect any update between the ASMO data and the final data in 2025 in regards to EVX01?
Christian Kanstrup: And we do have several partnerships, discussions ongoing. And this is of course key to execute upon our multi partner strategy that we see these discussions, advancing. What I'm also pleased about is that we are seeing progress on the EXO one program. We did present positive and validating phase two immune data at ASCO this year. We also presented our phase one results in a leading medical journal, including, including the 67% objective response rate from the phase one trial, which I'm very proud about, and very importantly, we are on track for a key milestone for evaction, our one-year clinical data readout, which will be presented at the ESMO Congress in September.
Birgitte Rono: So we are continuously generating more data also on the biomarker side. And yes, we do expect to in early 25 to present some more of that work. Excellent, thank you very much. And another question I have is regarding the Evax B1, B2 vaccine.
Speaker Change: I can answer that.
Speaker Change: Khalid, Adnan Khattak, Birgitte Rn,
Khalid: So, um...
Khalid: We are continuously generating more data also on the biomarker side and yes, we do expect in early 2025 to present some more of that work.
Christian Kanstrup: Can you give us a sense of what could be the potential scenario for the next step with development or in the collaboration with Afrigen? Yeah, I think that if we take B2 in general, right, you can say that it's of course at the pre-cleansates, and then it's, I think it's faster than one of the assessments where we are looking for partners to bring [inaudible] Partnership Discussions for the African collaboration in particular, which of course is for an mRNA based version for low and middle income countries. The next step is establishing preclinical proof of concept, which will be presented at this 18th Vaccine Congress in September.
Christian Kanstrup: Excellent. Thank you very much. And another question I have is regarding to Evax B2 vaccine. Can you give us a sense of what could be the potential scenario for the next step with
Speaker Change: The development with the collaboration with AFRIGEN.
Christian Kanstrup: So very nice progress on the EVX01 program. In addition to this, an important element is of course to continue strengthening our AI, even though the platform and our capabilities and that we have also progressed upon over the past quarter. Among other things, we did get the positive feedback on a patent application for an AI-based novel target identification method, which is based on the endogenous ritual viruses and of course creating a strong IP portfolio around our platform and around our pipeline as it is important for us.
Speaker Change: Yeah, I think if we take B2 in general, right, you can say that's of course at the preclinical stage and it's I think especially one of the assets where we are looking for partnering to bring it forward broadly. So next steps on B2 in general would be...
Speaker Change: Thank you very much for the partnership discussions, for the African collaboration in particular, which of course is for
Speaker Change: an mRNA-based version for low- and middle-income countries.
Christian Kanstrup: So getting this positive feedback is this milestone for the continued strengthening of our platform. Finally, I think worst mentioning is the fact that we did present at the computational biology conference not too long ago and improved performance of one of the building blocks of AI immunology. And as you might remember, then AI immunology has a quite unique modular structure where we have a number of building blocks used across the different AI models.
Speaker Change: There the next step is...
Christian Kanstrup: And that means improving the performance of one of these will improve the performance of those AI models where it's used. So having the opportunity of showcasing what we do to increase the predictive capabilities which we'll get back to later is a major element in strengthening and improving our AI immunology platform. So I would say it has been quite busy with several important parts of our strategy as we're answering since our last update.
Speaker Change: establishing the preclinical proof of concept which will be presented at this 18th Vaccine Congress in
Christian Kanstrup: And then next steps beyond that, that would depend on, you can say the data as well, but primarily this is a research collaboration focusing on establishing the proof of concept for use of the two B2 antigens in an mRNA construct. Got it. Maybe if I can squeeze in my last question, can you give us a sense of the current status of the IRF platform? What kind of preclinical data you are generating?
Speaker Change: September and and then next steps
Speaker Change: Beyond that, that would depend on, on, um,
Speaker Change: You can see the data as well, but primarily this is a research collaboration focusing on establishing the proof concept for use of the two B2 antigens in an mRNA construct.
Unknown Attendee: When do we see the data published or being announced? Thank you. Are you thinking in particular about the precision-based vaccine, where we have the milestone, or are you thinking more IRFs in general? I think you stated it's the updated timeline, second half of 2024. Yeah, yeah, that's the one I'm talking about.
Speaker Change: Got it. Maybe if I can squeeze in my last question. Can you give us a sense of the current status of the IRF platform? What kind of preclinical data you're generating? When do we see the data published or being announced?
Speaker Change: Are you thinking in particular for the precision-based vaccine where we have the milestone, or are you thinking more IRFs in general?
Christian Kanstrup: And I would also just on the next slide quickly recap on our strategy. Our strategy is unchanged. As you know, we have a three-pronged business model which is based upon AI immunology. So the core of our strategy that's AI immunology and then we have the multi-partner approach towards value realization. Then the three prongs, its targets, its pipeline and its responders within the target path that is about a multi-partner approach focusing around either single or multiple vaccine target discovery, design and development agreements.
Speaker Change: I think you stated that the updated timeline is the second half of 2024. Yeah, that's the one I'm talking about. Yeah, so the milestone later this year relates to
Christian Kanstrup: Yeah, so the milestone for later this year is or relates to the precision version of the vaccine, so meaning that we are currently developing a vaccine that fits a broader subset of patients with a certain indication, not personalized as such.
Speaker Change: So the precision version of the vaccine, so meaning that we are currently developing a vaccine that fits a broader subset of patients with a certain indication, so not personalized as such.
Christian Kanstrup: We are currently doing a lot of design studies and also preclinical evaluation of these designs to be ready for presentation at the conference later this year. And I would say personally, I'm super excited about the whole, first of all, as a novel cancer target, but also the concept of developing a precision vaccine, right, where you have the opportunity of reaching new patients, which you might not be able to reach with standard immunotherapy or with the personalized cancer vaccine due to a lower tumor mutational burden. So we're looking forward to seeing the data here later this year. Thanks very much.
Speaker Change: We are currently doing a lot of design studies and also preclinical evaluation of these designs to be ready for presentation at the conference.
Christian Kanstrup: And of course, the collaboration we have with MSD around EBXB3 is a great example of what we want to achieve here. Pipeline, that's taking select high-value programs forward ourselves, bringing these to key value inflation points. And again, that's why we are super excited about having the readout of the one-year clinical data from the phase two on EBX01 in September at the ESMO conference. This is going to be a key milestone for evaction. Finally, the responder part that's really about taking the core capabilities we have data predictive analysis and developing responder model. So, three-pronged business model remains in place, multi-partner approach to what's value-realization.
Speaker Change: later this year.
Speaker Change: And I would say personally, I'm super excited about the whole, first of all, IRB as a novel cancer target, but also the concept of developing a precision vaccine, right?
Speaker Change: where you have the opportunity of reaching new patients which you might not be able to reach with standard immunotherapy and or with the personalized cancer vaccine due to a lower tumor mutational burden. So we are looking forward to seeing the data here later on this year.
Unknown Attendee: Looking forward to the data. Thank you. We will now take our next question, please stand by. And the next question comes in the line of Thomas Flaten from Lake Street Capital Market. Please go ahead, your line is not open.
Speaker Change: Thanks very much, looking forward to the data.
Speaker Change: Thank you.
Christian Kanstrup: And then, before handing over to Birgitte, I just want to look a little bit forward because we have a number of important milestones to report shortly. In September at the ECCB conference, we will be launching the upgraded version of Eden model version 5.0 that we are looking very much forward to, and that of course, linked in to the continuous strengthening of our AI technology platform. Also in September at the 18th vaccine congress, we will be reporting out on the milestone for EVXB2 in an mRNA version, where we have been pursuing pre-clinical proof of concept.
Speaker Change: We will now take our next question. Please stand by. And the next question comes from the line of Thomas Flatton from Lake Street Capital Markets. Please go ahead, your line is now open. Hey Thomas!
Thomas Flaten: Thank you for taking the questions. Christian, I was wondering if you could maybe characterize the partnership discussions that you mentioned in the press release that are ongoing. Are they focused on infectious disease?
Thomas Flatton: Thank you for taking the questions. Christian, I was wondering if you could maybe characterize the the partnership discussions that you mentioned in the press release that are ongoing. Are they, you know, are they infectious disease focused? Are they cancer focused? Maybe across the board, you know, how advanced are those conversations? Just a little bit more color there would be super helpful.
Thomas Flatton: No, I would say, Thomas, without, of course, being able to go into a whole lot of detail, it's across the board. And that's also what I tried to say here, where we are seeing interest both in AI immunology
Christian Kanstrup: They have a cancer focus maybe across the board? How advanced are those conversations? Just a little bit more color there would be super helpful. No, I would say Thomas, without, of course, being able to go into a whole lot of detail. It's across the board.
Thomas Flatton: IEEE in, you could say, new target discovery collaborations like the one we have with MSD. But we're definitely also seeing interest in our pipeline assets, which is both from the cancer side and from the infectious disease side.
Christian Kanstrup: I already mentioned ESMO September, one year read out on EVX01, so a number of important milestones reporting out shortly. For the latter part of the year, we are still on track with our collaboration with MSD about EVXB3, where the first phase is going to conclude in the second half, we are on track with our Earth-based precision cancer vaccine, where we are pursuing the pre-clinical proof of concept that will also report out later on in the year.
Christian Kanstrup: And that's also what I tried to say here, with we are seeing interest both in AI immunologists, and you can say new target discovery collaborations like the one we have with MSD, but we're definitely also seeing interest in our pipeline assets, which are both from the cancer side and from the infectious disease side. And I would say some of these discussions are fairly advanced, which they also need to be given that we keep the milestone of 14 million US dollars in BD income this year because, you know, it of course takes time to get deals done.
Thomas Flatton: And I would say some of these discussions I...
Thomas Flatton: a fairly advanced, which they also need to be, given that we keep the milestone of the 14 million US dollars in BD income this year.
Christian Kanstrup: So I always say we have a good mix of things which are quite advanced and I quote across the board as well as new things coming in which would probably be more likely to be 2025 deals. So, I think given the fact that we only really started being very active in our BD efforts at the end of the first quarter, then I am very pleased with where we are now in the pipeline of deals and seeing that it is a broad-based interest.
Christian Kanstrup: And then finally, we have the ambition of generating business development income equal to our 2024 cash burn excluding financing activities that also remains. The only thing here is the attentive reader will see we have updated this wording here to say business development income all cash in, and that reflects the fact that of course now we are relatively later on in the year, hence if we get to the 14 million, it's uncertain if the accounting impact of upfront milestone will lead to full accounting for this in this year, or that will be leading into next year.
Thomas Flatton: because, you know, it of course takes time to...
Thomas Flatton: and get deals done. So I would say we have a good mix of things which are quite advanced and across the board as well as new things coming in.
Thomas Flatton: which would probably more likely be 2025 deals. So, I think given the fact that we only really started...
Thomas Flatton: very active in our BD efforts towards the end of the first quarter, then I am very pleased with where we are now in the pipeline of deals and seeing that it is a broad-based interest.
Christian Kanstrup: And then given where your spending was, particularly on R&D for the second quarter, can you help us think through how we should model spending, particularly on R&D for the second half of the year, given where you are with cash and the cash runway you've laid out? Yeah, I think you should be looking at slightly lower R&D spend in the second half of the year, and actually, the same goes for TNA.
Thomas Flatton: and then… End
Christian Kanstrup: So from an income point of view, it might be divided over 24 and 25, but from a cash point of view, we clearly have the ambition which remains intact of generating business development income of 14 million. But as you of course know, any business development activity is uncertain, so this remains an ambition. But as I also started out saying, we are seeing a very nice traction on our business development activities for several discussions ongoing.
Speaker Change: Given where your spending was, particularly in R&D for the second quarter, can you help us think through how we should model spending, particularly in R&D, for the second half of the year given
Speaker Change: where you are with cash and the cash runway you've laid out.
Speaker Change: Yeah, I think you should be looking at slightly lower R&D spent in the second half of the year.
Christian Kanstrup: So we will be having lower second half spend than the first half, and also, you can say from a cash out point of view, I mean, we are paying insurance, if we are paying in per year bonuses, et cetera, in Q1, so cash flow is also skewed towards the first half of the year.
Speaker Change: and actually the same goes for DNA. So we will be having a lower second half spend.
Speaker Change: that then the first half and also you can say from a cash out point of view.
Christian Kanstrup: Also please to say that we are seeing new potential partners approaching us on a regular basis. So strong activity around our business development activities and we are having the ambition of generating the 14 million this year, but of course uncertainty remains.
Speaker Change: I mean, we are paying insurance, we are paying...
Speaker Change: in Q1, so the cash flow is also skewed towards the first half of the year. So definitely looking at lower R&D as well as DNA in the second half.
Christian Kanstrup: So definitely looking at lower R&D as well as TNA in the second half and also lower cash out. Thanks, son. I appreciate you taking the questions. Thank you very much. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. To enjoy your question, please press that number one again. We will now take our next step. Please stand by.
Birgitte Rune: And with that, I will hand over to Brigitte for giving an update on the exciting and the activities that have taken place over the past quarter. Thank you, Kristen. It has been a very active and busy time during the last quarter, and today I will focus on the data from the phase two study of EVX-01 presented at ESCO in June and on the improvement on this central building block in our AI and on the platform, but because EVX is in the shape, and that building block is key for designing effective vaccines.
Speaker Change: and also lower cash out.
Speaker Change: Excellent. I appreciate you taking the questions. Thank you very much.
Speaker Change: Thank you. As a reminder to ask a question you will need to press star 11 on your telephone and wait for your name to be announced. To withdraw your question please press star 11 again. We will now take our next question.
Chong Liu: And the next question comes from the line of Chong Liu from Ladenburg. Please go ahead. Your line is now open.
Speaker Change: Please stand by.
Speaker Change: And the next question comes from the line of Chong Liu from Ladenburg. Please go ahead, your line is now open.
Christian Kanstrup: Hello, and this is Tron on behalf of Ahu Demir. We have a question regarding the upcoming results at Asmong. So, could you please give us more color on what we've... and besides the immunogenicity data, are we also... Fied Update, O-R-R, and the P-R-S. Yeah, thank you for that question. So we will present one year's clinical readout from the phase two study, and we will also present more biomarker analysis, including a few more cases of patients that have been boosted.
Birgitte Rune: The performance of this building block was presented at the computational biology conference called Intelligent System for Molecular Biology in July. So our EVX-01 lead product candidate is a personalized cancer vaccine designed to engage the patient's own immune system to fight the cancer. And the EVX-01 is currently in phase 2 in a global motor center trial in first line advanced melanoma. So the patient's enrolled in the phase 2 trial received standard of care, that is the checkpoint inhibitor from MSD called Ketuda, and they receive it according to label in combination with six initial EVX-01 priming doses, following five four additional booster doses.
Speaker Change: Hello, this is Chung for Ahu Demir.
John: We have a question regarding the upcoming results at ASIMO. So could you please give us more color on what we will expect to see? And besides the immunogenicity data, are we also expecting to see the update ORR and PFS or OS? Thank you.
Speaker Change: Thank you for that question. So we will present one year clinical readout from the phase 2 study and we will also present more biomarker analysis including a few more cases.
Christian Kanstrup: The exact data, the exact clinical data, we cannot say that yet exactly what it's going to be because we are a little bit reluctant to conclude on the primary endpoint when it's a preliminary readout. But it is going to be clinical data that we will be presenting. Of course, this is criteria, and the response of the clinical trial is all of the responses.
Speaker Change: of patients that have been boosted.
Speaker Change: The exact clinical data, we cannot say yet exactly what it's going to be because we are a little bit reluctant to conclude on the primary endpoint when it's a preliminary readout.
Birgitte Rune: So EVX-01 consists of 10 AI immunology identified. New antigens and new antigens are these short sequences that are exclusively found in tumors. And when administered to patients, they will induce a specific teaser response with tumor killing potential.
Speaker Change: But it is going to be clinical data that will be presented.
Speaker Change: Of course, this is criteria and the response of the clinical.
Christian Kanstrup: And so my next question is, will this fix the data without having your advance, maybe into the next stage of the partnership discussions in the future? I think the short answer to that is, of course, assuming it's good data, which we hope and expect. But no, there's no doubt that, I mean, when you are discussing personalized cancer vaccines, I think, given this is a novel concept, then the clinical data are important in partnering discussions. And that's also why this is an important milestone for us in that respect. So yes, it will be very important. Okay, and my next question is regarding the EVXB3.
Speaker Change: of the response.
Birgitte Rune: So in June, we presented encouraging immune data from the first 12 patients at ESO. And what the data demonstrated was that we could find EVX-01 induced teaser responses in all of these evaluated patients. And the graph to the right displays the EVX-01 induced immune response for a time. We've one represent baseline where the patients have not received any study therapy, which 12 is where the patients have been dose of Ketuda. And at week 18, that is during the EVX-01 priming phase, whereas week 30, that is after priming, but before the patients have received any booster immunization. So in all evaluated patients, we do see an increase in the teaser response upon vaccination with EVX-01. So further analysis also demonstrated that the teaser responses were mediated by CD4s and CD8 teaser responses.
Speaker Change: And so my next question is, will this Phase II data readout help you advance maybe into the next stage of the partnership discussion in the future?
Speaker Change: I think the short answer to that is yes, of course, assuming it's good data which we hope and expect, but no, there's no doubt that, I mean, when you are discussing a
Speaker Change: Personalized Cancer Vaccines. I think given this is a novel concept, then the clinical data are important in partnering discussions, and that's also why this is an important milestone for us in that respect.
Speaker Change: So yes, it will be very important.
Christian Kanstrup: So can you please provide some updates on that? Yes, so EVXP3 is a collaboration with ASD on an undisclosed pathogen vaccine, and it's running according to a contract, meaning that we have now assigned the antigens, we have produced them, and we are currently testing them in animal models. Well, we are on track with that collaboration, and then it is said that this first phase of the testing is said to conclude during the second half here. And then we will be discussing with MSD the next phase, which would be a more traditional licensing collaboration structure. Of course, assuming that that data looks like a problem.
Speaker Change: Okay and my next question is regarding the EVX B3. So can you please provide some updates for that?
Speaker Change: Evax B3 is a collaboration with CDC on an undisclosed pathogen vaccine and it's running according to a
Birgitte Rune: I've not included this data here, but they were presented at ESO. And there is currently a lot of debate about the roles of CD8s and CD4s. And we have also talked a lot about this. And we believe that it's very important that there is a balance between these two teaser types. We also saw that upon boosting, we could maintain the response in the patients. And we believe that this is critical for obtaining a doable clinical response.
Speaker Change: to contract, meaning that we have now designed the antigens, we have produced them, and we are currently testing them in animal models.
Speaker Change: We are on track with that collaboration.
Speaker Change: And that is set to, you can say, this first phase on the testing is set to conclude.
Speaker Change: during the second half here, and then we will be discussing with MSD the next phase, which would be a more traditional...
Birgitte Rune: What is also important that is to look at the single new antigens and their ability to induce a specific immune response. And the graph to the left depicts also the response to the individual new antigens in the vaccine over time. And at week 30, we could see that we had 64 out of the administered 90 antigens giving rise to a specific immune response, leading us with 71% of the positive hits. And that we believe also compares favorably to what we have seen other communicating.
Speaker Change: licensing collaboration structure, of course, assuming that the data looks promising.
Christian Kanstrup: And my last question is, so what is the difference between the new EDEM model version, like 5.1, from the old version? Yeah, you can say the over-arching objective with the upgrade is, of course, to increase the predictive capabilities of Eden, making us capable of identifying with greater certainty the right antigens but also possibly discovering targets which could not be discovered in other ways. We've been doing a couple of things.
Speaker Change: And my last question is, so what is the difference of the Eden new model version, like 5.1, from the old version?
Speaker Change: Yeah, you can say the overarching objective with the upgrade is of course to increase the predictive capabilities of Eden, making us capable of identifying,
Speaker Change: with the greater certainty identifying the right antigens but also possibly discovering targets which could not be discovered in other ways. We've been doing a couple of things. We've been expanding the training data set. What we have done is we have acquired
Christian Kanstrup: We've been expanding the training data set. What we have done is we have acquired additional training data from public sources using what we call retrieval augmented generation with last language models, and that has been followed by a manual domain expert duration.
Birgitte Rune: More or we correlated the AI immunology prediction scores and the new antigen tissue responses. And that is depicted on the graphs to the right. And that demonstrated a significant positive correlation also underlining the precision and predictive power of our AI immunology platform.
Speaker Change: Additional training data from public sources using what we call retrieval augmented generation with large language models.
Speaker Change: and that has been followed by a manual domain expert curation. And this enhanced dataset now includes the prediction of bacterial toxins, which is a new feature in Eden 5.0.
Christian Kanstrup: And this enhanced dataset now includes the prediction of bacterial toxins, which is a new feature in Eden 5.0. Also, we have called advanced protein feature prediction with developed a completely new building block for protein feature prediction. And we have fine-tuned the protein language model, thereby enhancing the models capabilities to predict various protein characteristics.
Birgitte Rune: So just to summarize, the escrow data we demonstrated, Evaxion wanted to use chisel responses in oral patients. The responses were mediated predominantly by chisels but also by CDH chisels. We saw that 71% of the new antigens and immune response and AI immunology new antigens quality score correlated with immune response. And in general, we believe that these fairly immune data are very encouraging and we are looking so much forward to presenting the one-year clinical readout that is more in September as Christian alluded to.
Speaker Change: Also, we have what we call advanced protein feature prediction. We developed a completely new building block for protein feature prediction.
Speaker Change: and we have fine-tuned the protein language model, thereby enhancing the model's capabilities to predict various protein characteristics.
Christian Kanstrup: And then all of this, as I said, about improving antigen identification; we have trained a new machine learning model in Eden specifically designed to identify antigens, improving both the accuracy and the reliability of antigen prediction. So I mean, in short, improving the predictive capabilities of Eden, which is a continuous process that we're doing with all our AI models, goes by taking a detailed focus on the individual models but also as Birgitte presented the Evax MHC building block, which is used across the models, improving it, and hence thereby improving the predictive capabilities of all models together.
Speaker Change: And then all of this is, as I said, about improving the antigen identification. We have trained a new machine learning model in Eden.
Speaker Change: specifically designed to identify antigens, improving both the you can say accuracy and the reliability of the antigen prediction. So, I mean in short, improving the predictive capabilities of EDEN, which is
Birgitte Rune: So changing focus a little bit, we are continuously working on improving our AI immunology platform. And one key feature is in developing effects of vaccine is the ability to accurately predict these small fragments known as pet sites, stemming from pathogens and cancer cells that are displayed on the surface of cells. And this allows the immune system to recognize and eliminate different.
Speaker Change: A continuous process that we're doing with all our AI models, both by taking a detailed focus on the individual model, but also as...
Speaker Change: and Birgitte presented on the EVAX MHC building block which is used across the models.
Christian Kanstrup: So we're definitely looking forward to presenting that in greater detail at the ECCB conference in September. And so I'm going to apply this new model to all programs. I mean that that's, of course, going to be applied to possible new target collaboration discussions or collaborations with Pharma Biotech as well as our own internal programs that we are looking to bring forward. We have a list of infectious disease targets that we would like to bring forward as well, and of course, this Eden 5.0 will be a great help in quickly advancing new candidates into our internal pipeline as well as it will be an additional value proposition towards external parties when we collaborate with them.
Speaker Change: Improving that and hence thereby improving the predictive capabilities of all models together. So we're definitely looking forward to presenting that in greater detail at the ECCB conference in September .
Birgitte Rune: So we have worked on improving one of these key building blocks in AI immunology, the one called PEP sites in the C and that actually predicts which peptides that are most likely to be displayed on the surface of cells and they are by the most puttically relevant vaccine type. So with this improvement, we have used state of the art in novel deep learning framework work and we have also trained the models on publicly and proprietary data.
Speaker Change: Deepak.
Speaker Change: And so I'm going to apply this new model to any programs.
Speaker Change: I mean that that's of course going to be applied to
Speaker Change: [inaudible]
Speaker Change: possible new target collaboration discussions or collaborations with
Speaker Change: with Pharma Biotech as well as our own internal programs that we are looking to bring forward.
Speaker Change: and List of infectious disease targets that we would like to bring forward as well. And of course, there this Eden 5.0 will be a great help in...
Birgitte Rune: And we saw that when we compared to publicly available source, there was an improved performance of this building block. So with these improvements, we anticipate to further enhance the ability to accurately predict vaccine targets, and we also envision that these updated versions of EVX-EVX-NC will lead to an improved design of our vaccines.
Speaker Change: in quickly advancing new candidates into our internal pipeline, as well as it will be an additional value proposition towards external parties when we collaborate with them.
Christian Kanstrup: Great, thank you. Thank you. As there are no further questions, I would now like to hand over to Christian Kanstrup for any closing remarks.
Speaker Change: Great, thank you.
Speaker Change: Thank you.
Christian Kanstrup: Thank you so much. I just want to say thank you to all of you who are either dialing in or joining the webcast. And also, thank you so much for the question. We also always appreciate good dialogue. So, thank you so much for that. And now, we are looking forward to reporting on the key milestones ahead, in parallel with advancing the different discussions that we have ongoing. So, thank you so much to all of you for listening in. Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. (inaudible)
Speaker Change: As there are no further questions, I would now like to hand back to Christian Kanstrup for any closing remarks.
Jesper Nissen: [inaudible] VX-EVX-EVX-EVX-EVX-EVX-EVX-EVX-EV[inaudible] VX-EVX-EVX-EVX-EVX-EVX[inaudible] by a smaller increase in cost related to clinical trials.
Christian Kanstrup: Thank you so much. I just want to say thank you to all of you either dialing in or joining the webcast and also thank you so much for the question.
Christian Kanstrup: Always appreciate the good dialogue. So thank you so much for that. And now we are looking forward to be reporting on the key milestones ahead in parallel with advancing the different discussions that we have ongoing. So thank you so much to all of you for listening in.
Speaker Change: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.
Jesper Nissen: General and administrative expenses were 3.6 million for the six months in the June 30. The decrease of 1.7 million versus the same period in 2023 was primarily due to reduced external cost related to professional fees as well as reduced employee cost for the period. Finance income and expenses for the first six months of 2024 are primarily impacted by effects from the remissionment of the derivative liability related to investor runs from the public offering in February 2024 as well as the private placement in December 2023. These effects have been eliminated going forward as the investor runs have had their exercise currency changed from the USD to DKK during Q2, moving them from being recognized as financial instruments to equity instruments.
Christian Kanstrup: And with this I would like to turn back to you Christian for your exclusive remarks before the Q&A. Thank you so much Jesper and thanks for the update on the numbers.
Christian Kanstrup: Let me just quickly provide a few conclusive remarks before we jump into the Q&A part. I think it's fair to say that we are seeing a solid progress on our three-pronged business model and a very good traction along the different parts. Importantly also we are having a strong focus on advancing ongoing business development discussions which of course is a key milestone for us this year as well that we will be focusing on a value generation via a multi-partner approach.
Christian Kanstrup: Again the data beginning presented shows that EVX 1 continues to deliver solid data and we do have a medium milestone coming up here at ESMO in September and in addition to that it is going to be a busy time ahead with several of our other 2024 milestones going to report out just as we are on track for delivering on remaining milestones during the second half of the year. So all in all I would say I'm very pleased with the progress we are seeing a strong focus upon execution and bringing our strategy forward.
Operator: So with that I would very much like to mark for the Q&A session so please just join the Q&A session. Thank you. As a reminder to ask a question you will need to press star one one on your telephone and wait for your name to be announced. To withdraw your question please press star one one again. We will now take our first question please stand by.
Lee 10: And the first question comes from the line of Lee 10 from HC Wayne Wright. Please go ahead your line is not open.
Christian Kanstrup: Hello, everyone. Yeah, hi, Christian. Congratulations on this great quarter. That's a couple of questions. First, do we expect any update between them? I have more data and the final data in 2025 in regards to EVX01? I can answer that highly. So we are continuously generating more data also on the biomarker side, and yes, we do expect to in in early 25 to present some more of that work.
Operator: Excellent. Thank you very much.
Christian Kanstrup: And another question I have is regarding to EVXB, B2 vaccine. Can you give us a sense of what could be the potential scenario for the next step with the development with the collaboration with Afregion? Yeah, I think that if we take a B2 in general, right, you can say that's of course at the pre-cleanestates. And it's I think especially one of the assets where we are looking for for partnering to bring it forward.
Christian Kanstrup: So so next steps on B2 in general would be be partner shift discussions for for the Afregion collaboration in particular, which of course is for an mRNA based version for low and middle income countries. There the next step is establishing the pre-cleanestate proof of concept, which will be presented at this 18th vaccine conquest in September. And then next steps beyond that, that would depend on you can say the data as well. But primary, this is a research collaboration focusing on establishing the proof concept for use of the two B2 antigens in an mRNA construct.
Christian Kanstrup: Got it. Maybe you can squeeze in my last question. Can you give us a sense of the current status of the earth platform, what kind of pre-cleanestated data you have generating? When do we see the data published or being announced? Thank you. Are you thinking in particular for the precision based vaccine, which we have the milestone, I think in general? I think you use that stated the updated timeline second half of the 24.
Christian Kanstrup: Yeah, that's the one I'm talking about. So the milestone in later this year is related to the precision version of the vaccine. So meaning that we're currently developing a vaccine that fits a quarter subset of patients with a certain indication, so not personalized as such. And we're currently doing a lot of design studies and also pre clinical evaluation of these designs to be ready for a presentation at the conference. Later this year.
Christian Kanstrup: And I would say personally, I'm super excited about the whole, first of all, Earth as a novel cancer target, but also the concept of developing a precision vaccine, right, where you have the opportunity of reaching new patients, which you might not be able to reach with standard immunotherapy and with the personalized cancer vaccine due to a lower tumultrational burden. So we're looking forward to seeing the data here later on this year.
Operator: Thanks very much, we're looking forward to the data. Thank you.
Thomas Flaten: We will now take our next question, please stand by. And the next question comes in the line of Thomas Flaten from Lake Street Capital Market. Please go ahead.
Christian Kanstrup: Your line is not open. Hey, Thomas. Hey, thank you for taking the questions. Christian, I was wondering if you could maybe characterize the partnership discussions that you mentioned in the press release that are ongoing. Are they infectious disease focus? They cancer focus maybe across the board. How advanced are those conversations? Just a little bit more color there would be super helpful. No, I would say Thomas, without of course being able to go into a whole lot of detail.
Christian Kanstrup: It's across the board. That's also what I tried to say here where we are seeing interest both in AI immunology. IE in you can say new target discovery collaborations like the one we have with MSD, but we're definitely also seeing interest in our pipeline assets, which is both from the from the cancer side and from the infectious disease side. And I would say some of these discussions are fairly advanced, which they also need to be given that we keep the milestone of the 14 million US dollars in BD income this year because it of course takes time to get deals done.
Christian Kanstrup: So I always say we have a good mix of things which are quite advanced and across the board as well as new things coming in, which would probably more likely be 2025 deals. So I think given the fact that we only really started very active in our BD efforts. Towards the end of the first quarter then I am very pleased with where we are now in the pipeline of deals and seeing that it is a broad-based interest.
Christian Kanstrup: And then given where you're spending was particularly in R&D for the second quarter, can you help us think through how we should model spending, particularly in R&D for the second half of the year given where you are with cash and the cash runway you've laid out? Yeah, I think you should be looking at the slightly lower R&D spend in the second half of the year. And actually the same goes for TNA.
Christian Kanstrup: So we will be having lower second half spend than the first half. And also you can say from a cash out point of view, I mean we are paying insurance, we are paying in BD bonus etc in Q1. So cash flow is also skewed towards the first half of the year. So definitely looking at lower R&D as well as TNA in the second half and also the work cash out. Excellent, I appreciate you taking the questions. Thank you very much.
Operator: Thank you. As a reminder to ask a question, you will need to press star one, one on your telephone and wait for your name to be announced. To adore your question, please press star one, one again.
Operator: We will now take our next question.
Chong Liu: Please stand by. And the next question comes from the line of Chong Liu from Ladenburg. Please go ahead.
Christian Kanstrup: Your line is now open. Hello, and this is Chong for Ahu Demir. We have a question regarding the upcoming results at Asmong. So could you please give us more color on what we will expect to see. And besides the energy data, are we also expecting to see the update ORR on the PLS or OS? Thank you. Yeah, thank you for that question. So we will present one your clinical readout from the phase two study.
Christian Kanstrup: And we will also present more biomarker analysis, including a few more cases of patients that have been boosted the exact data, the exact clinical data. We cannot say that yet exactly what it's going to be because we are a little bit often to conclude on the primary endpoint when it's a preliminary readout. But it is going to be a clinical data that we will be present. A clinical data, so of course this is criteria and the response of the clinical of their response.
Christian Kanstrup: And so my next question is, will this phase two data read out how you advance maybe into the next stage of the partnership discussion in the future? I think the short answer to that is yes. Of course, assuming it's good data with which we hope and expect, but there's no doubt that when you are discussing personalized cancer vaccines, I think given this is a novel concept, then the clinical data are important in partnering discussions. And that's also why this is an important milestone for us in that respect. So yes, it will be very important.
Christian Kanstrup: Okay, and my next question is regarding the EVX-B3. So can you please provide some updates for that? Yes, so EVX-B3 is a collaboration with a C on an undisclosed pathogen vaccine and it's running according to contracts, meaning that we have now the science, the antigens, we have produced them and we are currently testing them in animal So, we are on track with that collaboration. And then that is said to say this first phase on the testing is said to conclude during the second half here. And then we will be discussing with MSD, next phase which would be a more traditional licensing collaboration structure of course assuming that the data looks promising.
Christian Kanstrup: And my last question is, so what is the difference of the Eden new model version like 5.1 from the old version? Yeah, you can say the over-arching objective with the upgrade is of course to increase the predictive capabilities of Eden making us capable of identifying with the greater certainty, identifying the right antigens but also impossibly discovering targets which could not be discovered in other ways. And we have been doing a couple of things.
Christian Kanstrup: We have been expanding the training data set. What we have done is we have acquired additional training data from public sources using what we call retrieval augmented generation with last language models and that has been followed by a manual domain expiration. And this enhanced data set now includes the prediction of bacterial toxins which is a new feature in Eden 5.0. Also we have what we call advanced protein feature prediction. We developed a completely new building block for protein feature prediction and we have fine tuned the protein language model thereby enhancing the models' capabilities to predict various protein characteristics.
Christian Kanstrup: And then all of this is as I said about improving the antigen identification. We have trained a new machine learning model in Eden specifically designed to identify antigens, improving both the accuracy and the reliability of the antigens prediction. So I mean in short improving the predictive capabilities of Eden which is a continuous process that we are doing with all our AI models and goes by taking a detailed focus on the individual model but also as beginning presented on the EBIX MHC building block which is used across the models, improving that and enhance thereby improving the predictive capabilities of all models together.
Christian Kanstrup: So we are definitely looking forward to presenting that in greater detail at the ECCP conference in September. And so I am going to apply this new model to any programs. I mean that's of course going to be applied to as well as our own internal programs that we are looking to bring forward. We have a list of infectious disease targets that we would like to bring forward as well. And of course, there this Eden 5.0 will be a great help in quickly advancing new candidates into our internal pipeline as well as it will be additional value proposition towards external parties when we collaborate for them.
Operator: Great, thank you. Thank you.
Christian Kanstrup: As there are no further questions, I would now like to hand back to Christian Kanstrup for any closing remarks. Thank you so much. I just want to say thank you to all of you either dialing in or joining the rep cast and also thank you so much for the question. We also always appreciate the good dialogue. So thank you so much for that. And now we are looking forward to be reporting on the key milestones ahead in parallel with advancing the different discussions that we have ongoing. So thank you so much to all of you for listening in. Thank you.
Operator: This concludes today's conference call. Thank you for participating.
Operator: You may now disconnect. Thank you.