Evaxion A/S — Call Transcript 2025

Morning and good afternoon, and thank you all for joining our Q3 2025 Business Update and Financial Results Conference Call. I'm Birgitte Rønø, Chief Scientific Officer and Interim CEO of Evaxion. I'm joined today by Thomas Schmidt, Chief Financial Officer, and Mads Kronborg, Vice President of Investor Relations and Communications. I'll begin by walking through the agenda for today's presentations. I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, we will open for questions. I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risk and uncertainties, and actual results may differ materially. First and foremost, I'm pleased to welcome effective November 24. So Dr. Tayton-Martin brings extensive biotech leadership, fundraising, and partnership experience. Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. Helen holds a PhD in molecular immunology and an MBA, and with more than 30 years of experience in early research through product approval, Helen is an ideal candidate to lead the next stages of Evaxion's strategy. This also means that I will return to my previous role as CSO, and with Helen's transition from director on the board to CEO, Jens Bitsch-Nørhave will join the board as an advisor and observer with the intention to seek election at the next AGM. Since the last business update, we have made several significant achievements: historic in-licensing of EVX-B3 by MSD, providing significant cash and validation. The extended evaluation period for EVX-B2 has been extended. We have several ongoing partnership discussions, though market uncertainty affects deal climate. We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia, to our pipeline. Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. Lastly, we have strengthened our financial position, and we now have cash runway extended to the second half of 2027, and this is based on a $7.5 million option exercise fee received from MSD and an additional capital market funding sources, and Thomas will share details around this. As mentioned, one of the main highlights of the quarter is the MSD transformative deal. In September 25th, it was a historical moment for Evaxion, with MSD or Merck exercising their option on EVX-B3. This was the first-ever in-licensing of an AI-discovered vaccine candidate by a major pharma company. As mentioned, the $7.5 million exercise fee extends our cash runway significantly. The deal confirms our strategy of value creation through partnerships, even with industry giants like MSD. It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. Not related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. 2025 is shaping up to be a pivotal year for Evaxion. We've achieved several key milestones since the last business update. As mentioned, MSD exercised their option on EVX-B3, we presented two-year clinical outcome data from our EVX-01 phase II study, and we have announced the addition of EVX-04 to our pipeline, and EVX-04 is the lead candidate for our precision cancer vaccine, and looking ahead, we are expecting to provide further R&D and business development updates, so let's shift focus to our recent R&D and AI-Immunology progress. EVX-04 is our novel AI-designed cancer vaccine candidate targeting non-conventional antigens from the dark genome, so-called endogenous retroviruses or ERVs. And these ERVs are specifically expressed in cancers predominant in normal tissue, making them an attractive target for cancer vaccines. EVX-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia, where we know relapses remain a major challenge. The vaccine is based on our AI-immunology platform, leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that match the ERV expression profile and also the immune characteristics in patients, and we have now designed the lead candidate and have conducted preclinical studies. Next steps include GMP manufacturing and additional R&D enabling studies to prepare for a first-in-human study. With the EVX-01 lead vaccine candidate selected, the program has been added to our pipeline. Further changes include the removal of the EVX-02 program, as we do not have any active development currently ongoing on this program. The EVX-02 vaccine program served as proof of concept for DNA delivery of neoantigen and has informed on the design of both EVX-03 and EVX-04. Our lead program, EVX-01, is a personalized cancer vaccine that includes multiple patient-specific targets, so-called neoantigens, that we identify with our AI-Immunology platform from patient tumor material. EVX-01 is administered in combination with pembrolizumab, an immune checkpoint inhibitor, to enhance the clinical efficacy. In October, we presented two-year clinical outcome data from our phase II trial in an oral session at the ESMO Congress. The results are highly encouraging and were received well by the scientific and medical community. At the congress, we reported a 75% objective overall response. We also saw that 11 out of 12 patients that responded had a sustained response at two-year mark. We also saw a 34% conversion rate, meaning that patients with stable disease or partial response deepened their response upon EVX-01 treatment. So, we find the clinical outcome data very encouraging, and further, we believe that they compare favorably to historical pembrolizumab therapy data. Equally encouraging is the strong immunological activity of EVX-01, which is critical for long-term efficacy. So, in all patients treated with EVX-01, we saw a neoantigen-specific T-cell response. Further, when assessing the individual neoantigen immune responses, we demonstrated that 81% of the vaccine neoantigens administered across patients were immunogenic. So, this high hit rate provides strong evidence of the predictive power of our AI-immunology platform. We also showed that the immune responses were sustained throughout the two-year trial period. Even after the dosing period ended, T-cell activity remained high, indicating lasting immune memory. And durable T-cell responses are essential for preventing relapses and in achieving long-term control of melanoma. This reinforces the potential of EVX-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with a standard of care, but also builds on a robust immune defense. As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development timelines. It enables us to optimize vaccine candidates with high precision, both for new and approved vaccines. From data input to candidate generation, the process is now fully automated, ensuring optimal sequence and conformation of vaccine targets. As mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. Further, it seamlessly connects the downstream processes, supporting a smooth transition from design to production. The design module has already been applied in some of our key R&D projects. Our first example is the use of the module to identify and select regions of an antigen that can be expressed. We noticed that the full length of a particular antigen could not be expressed due to solubility constraints. When we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen. Another example of the application is that we can, with the module, predict most optimal sequences of a vaccine target based on a given antigen protein structure. Here, we have also been able to rescue a hard-to-express protein that would require labor-intensive and trial-and-error design approaches to find expressible constructs. With this new design module, it positioned us at the forefront of AI-driven vaccine innovation and further enabled us to move fast from target discovery to final product candidate. So, in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. And we look forward to updating you as our programs continue to advance. So, with that, I would like to give the word to Thomas to present the financial results. Yes, thank you, Birgitte. I am happy to present the financial results for the quarter. And maybe let me just start with an overview of the achievements that we have done throughout the year up until now, based on strong execution of our financial strategy. As we can see here on the slide also, throughout the year, we have made a number of activities with capital market activities, with, of course, also the agreement that we did with the European Investment Bank of debt conversion, plus also MSD out-licensing of the EVX-B3. So, throughout the year and up until the end of October, we have activities to the amount of $31.8 million, all which basically helps strengthen our equity and certainly also our runway, which is now extended into the second half of 2027. So, really a good and strong achievement and following the financial strategy that we have laid out. If we zoom in on the third quarter and the highlights from the third quarter, we certainly have had a strong financial quarterly performance. As mentioned, the cash runway now has been extended into the second half of 2027. And we've also seen in the quarter the option exercised by Merck or MSD, which not only provides cash income now, but also has a future revenue income of potentially up to $592 million. We are well on track also in the third quarter on delivering on our financial targets for the full year, and throughout the quarter, we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income, so really a good and strong quarter. If we look a little bit closer on the profit and loss element of it, clearly the revenue from MSD drives the quarterly operational gain, the first of its kind for Evaxion, but also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter, so also from earlier communications, we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level. Net financials in the quarter is to the tune of $1.3 million, driven by the debt conversion that we did in July. The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10th. That premium has been recorded on the financial income for the quarter, and that then brings the income for the quarter to $4.6 million. Turning to the balance sheet, we certainly, as mentioned already, have continued the strong execution that also has improved our equity. The equity now stands at the end of the quarter at $16.6 million. Included in the equity is a derivative liability with a net impact of $1.5 million. The derivative stems from our public offering in January and the investor warrants that we had from that date. However, in October, we have seen, as mentioned already, warrant exercises of 2.7 million, which means that this net impact of the derivative will be at a minimal value at the end of the year, so also a good outcome. It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrant of 2.8 million. Also, important to note is that our cash balance end of June is at a sound and solid $10.6 million, and we'll see further cash income as we or cash flow in as we received in October, the revenue income from MSD and also the cash from the sales of shares due to the investor warrant exercise. And last but not least, the debt conversion to equity conversion with the European Investment Bank really has strengthened our balance sheet, has improved our cash flow as we move forward, and has certainly also lowered our leverage. So, really a great outcome from that event also. So, a good solid quarter following along our financial strategy. And with that, I then hand it back to Birgitte. Thank you, Thomas. So, lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority, and multiple parallel partnership discussions are currently ongoing. Cash runway is extended to the second half of 2027. And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. Please follow the operators' instructions. Thank you. Thank you. As a reminder, if you wish to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, press star one one again. Please stand by while we prepare the first question. First question comes from Soumit Roy at JonesTrading. Your line is open. Please go ahead. Good morning, everyone, and congratulations on all the progress this quarter. A quick question on the EVX-01. If you can give us any color on the potential partnership deal, what is the key question that you're getting from a partner? Do they want to wait for much longer-term data or any other key achievements you have to present for a successful deal? Yeah, thank you for that question. So, we just presented, as mentioned, the two-year clinical outcome data. And I would say that we have moved from questions around quality of data, how does your platform work, to more, how can we apply your technology within perhaps other types of cancer indications. So, the data was received well, and we have been discussing it with key opinion leaders. We have also been discussing it with potential partners. And the strategy is that we will out-license it at the current development stage, and then the partner can, of course, decide on potential next steps. If we continue on the track we are currently with advanced melanoma, the next most likely step would be to conduct a larger randomized control arm study comparing the combination of EVX-01 plus standard of care to standard of care alone, so that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden, meaning that we can select high-quality new antigens and formulate a vaccine that would benefit the patient, so multiple different discussions are ongoing, and also different questions are coming our way, but generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward together and find solutions for manufacturing and also for other indications. Got it. Thank you. Thank you for that. One last question. Congrats on unveiling the EVX-04 in the AML program. If you can give us a slight understanding on the target or how is it expressed on AML stem cells? CD33, CD123 have been tried, and trying to understand what is the differentiation from this target. Yeah. No, this is a very good question. So, the way that we have applied our AI-Immunology platform is that we look at genomic and transcriptomic data. And for this particular type of antigens, we mainly look at transcriptomic data. So, the sequences that are being expressed as messenger RNA or RNA in general in the tumors. And then we started out by actually analyzing several different types of novel classes of antigens. And we realized that in certain indications, and AML is one of them, there's a very high expression level of these endogenous retroviral sequences from the dark genome, meaning that we can, across patients, find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine. So, this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients. But we're still using AI-Immunology and our core technology to identify the most optimal antigens. Now it's just coming from the dark genome. Got it. Thank you so much, and congratulations again on the progress. Thank you. Thank you. Please stand by for your next question. The next question comes from Nelson Cox at Lake Street Capital. Your line is open. Please go ahead. Hey, Nelson on for Thomas. Congrats on all the progress here this quarter. I'll maybe ask my two upfront apologies if I've kind of missed some of this. I've had some technical issues, but a lot of updates here as of late. Maybe at a high level, can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? And then when you look at the proportion of your business development conversations you're having today, can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline? Thanks. Yeah, hi Thomas. Thank you for that question. So, we do have multiple dialogues ongoing, and I would say that the interest is across our R&D pipeline, but also centered around our capabilities for identifying novel targets, so classical target discovery programs. There's interest in our oncology programs, and there's also interest in our infectious disease programs. It's a little bit mixed, I would say, and some companies do have preferences in infectious disease. Some do have interest in both vaccine candidates that we have developed and in target discovery collaborations, so a little bit of mix, and that confirms, I would say, our strategy to monetize on both our own in-house developed vaccine candidates, but also to enter into target discovery collaborations. I cannot comment so much on exactly where we are, as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal. But a lot of activities, and we can see that the interest is increasing when we have major data readouts, as we have had in this last quarter with the EVX-01 phase II data coming out. Great. Thanks for taking questions. Please stand by for your next question. As a reminder, if you do have a question, please press star one one on your telephone. The next question comes from Swayampakula Ramakanth at H.C. Wainwright. Your line is open. Please go ahead. Thank you. Thank you. This is RK from H.C. Wainwright. Good afternoon, Birgitte and team. Hi. So, certainly, there are very interesting developments going on at the company. So, can we focus for a second on your automated design module, which is yet another interesting AI design drug design module that you have? So, how should we think about this? Is this something that can help your internal designing I mean, designing of your internal molecules only, or is this up for entering into partnerships, or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules? It looks like there's a lot of places where this thing could go. And what are your thoughts on that? Yes, you're absolutely right. It can go in multiple directions. So, in the past, we have used AI-Immunology to identify novel vaccine targets. And then these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. And this process has been labor-intensive. So, the ambition was to set up an automated process for this. We have now been able to launch a new module where several different AI tools are being integrated, enabling us to go from target discovery to product candidate selection very fast. So, that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or, in general, key targets, that these antigens or targets can also be produced in a cost-effective way. So, I do see multiple options for monetizing on this new module. Okay. So, and then coming into the real world and talk about EVX-01 for another minute. At ESMO, you are planning to present some additional data from the ongoing trial. What sort of data would come out from there, and how would it strengthen your narrative on EVX-01, not only for yourselves but also for a potential partner, whether it is just on the drug or on the platform, just as you were talking about when you were answering, Soumit Roy? Yeah. So, at ESMO, we presented the clinical outcome data, and we are still in the process of analyzing patient samples. So, we have collected blood samples before therapy, during vaccination, and then also as follow-up samples. And all of these samples from the patients are currently being assessed in our own lab. So, we do, of course, monitoring of the EVX-01-induced T-cell responses, but we also do deeper phenotypic analysis. So, some of this will go out at SITC. We have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients, so more to come, more deep dives into the immune profiles of the cells collected from the patients, and then we also have the extension phase of the EVX-01 trial, where six patients are now receiving EVX-01 as a monotherapy, so more data will come from this subset of patients. Perfect. Thank you for that, and then my last question is on the MSD relationship. I mean, it's great to have the $7.5 million, but how much more do you still need to give any additional data for the second molecule, or is it the Merck still has to complete their due diligence on the data that you're giving them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million? Yeah. So, for EVX-B2, MSD is currently evaluating the data that we have provided, and further, they are in the process of generating some confirmatory analysis, and that was also why the evaluation period was extended, so we expect that they will come back with an answer in the second or in the first half of next year. Perfect. The process is ongoing, and it's, of course, very exciting, and we would love to out-license EVX-B2 to MSD. Yeah. Okay. Great. Thank you. Thank you very much for taking all my questions. Thank you. Thank you. There are no further questions, so I shall hand back to you for final remarks. Yes, and thank you for joining us today, and please do not hesitate to reach out should you have any additional questions. Thank you.

Speaker 4: Morning and good afternoon, and thank you all for joining our Q3 2025 Business Update and Financial Results Conference Call. I'm Birgitte Rønø, Chief Scientific Officer and Interim CEO of Evaxion. I'm joined today by Thomas Schmidt, Chief Financial Officer, and Mads Kronborg, Vice President of Investor Relations and Communications. I'll begin by walking through the agenda for today's presentations. I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, we will open for questions. I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risk and uncertainties, and actual results may differ materially. First and foremost, I'm pleased to welcome effective November 24. So Dr. Tayton-Martin brings extensive biotech leadership, fundraising, and partnership experience. Morning and good afternoon, and thank you all for joining our Q3 2025 Business Update and Financial Results Conference Call. morning and good afternoon and thank you all for joining our q3 2025 business update and financial results conference call I'm Birgitte Rønø, Chief Scientific Officer and Interim CEO of Evaxion. i'm birgitte rønø chief scientific officer and interim ceo of evaxion I'm joined today by Thomas Schmidt, Chief Financial Officer, and Mads Kronborg, Vice President of Investor Relations and Communications. i'm joined today by thomas schmidt chief financial officer and mads kronborg vice president of investor relations and communications I'll begin by walking through the agenda for today's presentations. i'll begin by walking through the agenda for today's presentations I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. i'll start with a brief introduction followed by an r&d update and then thomas will present the q3 financial results And lastly, after a few conclusive remarks, we will open for questions. and lastly after a few conclusive remarks we will open for questions I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risk and uncertainties, and actual results may differ materially. i'd like to remind everyone that today's presentation may contain forward-looking statements and these are subject to risk and uncertainties and actual results may differ materially First and foremost, I'm pleased to welcome effective November 24. first and foremost i'm pleased to welcome effective november 24 So Dr. Tayton-Martin brings extensive biotech leadership, fundraising, and partnership experience. so dr tayton-martin brings extensive biotech leadership fundraising and partnership experience Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. Helen holds a PhD in molecular immunology and an MBA, and with more than 30 years of experience in early research through product approval, Helen is an ideal candidate to lead the next stages of Evaxion's strategy. This also means that I will return to my previous role as CSO, and with Helen's transition from director on the board to CEO, Jens Bitsch-Nørhave will join the board as an advisor and observer with the intention to seek election at the next AGM. Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. helen co-founded adaptimmune and has held several senior executive roles in adaptimmune Helen holds a PhD in molecular immunology and an MBA, and with more than 30 years of experience in early research through product approval, Helen is an ideal candidate to lead the next stages of Evaxion's strategy. helen holds a phd in molecular immunology and an mba and with more than 30 years of experience in early research through product approval helen is an ideal candidate to lead the next stages of evaxion's strategy This also means that I will return to my previous role as CSO, and with Helen's transition from director on the board to CEO, Jens Bitsch-Nørhave will join the board as an advisor and observer with the intention to seek election at the next AGM. this also means that i will return to my previous role as cso and with helen's transition from director on the board to ceo jens bitsch-nørhave will join the board as an advisor and observer with the intention to seek election at the next agm Since the last business update, we have made several significant achievements: historic in-licensing of EVX-B3 by MSD, providing significant cash and validation. The extended evaluation period for EVX-B2 has been extended. We have several ongoing partnership discussions, though market uncertainty affects deal climate. We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia, to our pipeline. Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. Lastly, we have strengthened our financial position, and we now have cash runway extended to the second half of 2027, and this is based on a $7.5 million option exercise fee received from MSD and an additional capital market funding sources, and Thomas will share details around this. Since the last business update, we have made several significant achievements: historic in-licensing of EVX-B3 by MSD, providing significant cash and validation. since the last business update we have made several significant achievements historic in-licensing of evx-b3 by msd providing significant cash and validation The extended evaluation period for EVX-B2 has been extended. the extended evaluation period for evx-b2 has been extended We have several ongoing partnership discussions, though market uncertainty affects deal climate. we have several ongoing partnership discussions though market uncertainty affects deal climate We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia, to our pipeline. we have presented two-year clinical efficacy data for evx-01 at the esmo congress and we have added evx-04 a novel therapeutic cancer vaccine for acute myeloid leukemia to our pipeline Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. further we have expanded our ai-immunology platform with an automated vaccine design module improving quality and reducing vaccine design time Lastly, we have strengthened our financial position, and we now have cash runway extended to the second half of 2027, and this is based on a $7.5 million option exercise fee received from MSD and an additional capital market funding sources, and Thomas will share details around this. lastly we have strengthened our financial position and we now have cash runway extended to the second half of 2027 and this is based on a $7.5 million option exercise fee received from msd and an additional capital market funding sources and thomas will share details around this As mentioned, one of the main highlights of the quarter is the MSD transformative deal. In September 25th, it was a historical moment for Evaxion, with MSD or Merck exercising their option on EVX-B3. This was the first-ever in-licensing of an AI-discovered vaccine candidate by a major pharma company. As mentioned, the $7.5 million exercise fee extends our cash runway significantly. The deal confirms our strategy of value creation through partnerships, even with industry giants like MSD. It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. Not related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. 2025 is shaping up to be a pivotal year for Evaxion. We've achieved several key milestones since the last business update. As mentioned, one of the main highlights of the quarter is the MSD transformative deal. as mentioned one of the main highlights of the quarter is the msd transformative deal In September 25th, it was a historical moment for Evaxion, with MSD or Merck exercising their option on EVX-B3. in september 25th it was a historical moment for evaxion with msd or merck exercising their option on evx-b3 This was the first-ever in-licensing of an AI-discovered vaccine candidate by a major pharma company. this was the first-ever in-licensing of an ai-discovered vaccine candidate by a major pharma company As mentioned, the $7.5 million exercise fee extends our cash runway significantly. as mentioned the $7.5 million exercise fee extends our cash runway significantly The deal confirms our strategy of value creation through partnerships, even with industry giants like MSD. the deal confirms our strategy of value creation through partnerships even with industry giants like msd It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. it also validates our ai-immunology and r&d pipeline and further ensures the development of evx-b3 without cost for evaxion Not related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. 2025 is shaping up to be a pivotal year for Evaxion. not related to the evx-b3 deal as such the evx-b2 evaluation period has been extended 2025 is shaping up to be a pivotal year for evaxion We've achieved several key milestones since the last business update. we've achieved several key milestones since the last business update As mentioned, MSD exercised their option on EVX-B3, we presented two-year clinical outcome data from our EVX-01 phase II study, and we have announced the addition of EVX-04 to our pipeline, and EVX-04 is the lead candidate for our precision cancer vaccine, and looking ahead, we are expecting to provide further R&D and business development updates, so let's shift focus to our recent R&D and AI-Immunology progress. EVX-04 is our novel AI-designed cancer vaccine candidate targeting non-conventional antigens from the dark genome, so-called endogenous retroviruses or ERVs. And these ERVs are specifically expressed in cancers predominant in normal tissue, making them an attractive target for cancer vaccines. EVX-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia, where we know relapses remain a major challenge. As mentioned, MSD exercised their option on EVX-B3, we presented two-year clinical outcome data from our EVX-01 phase II study, and we have announced the addition of EVX-04 to our pipeline, and EVX-04 is the lead candidate for our precision cancer vaccine, and looking ahead, we are expecting to provide further R&D and business development updates, so let's shift focus to our recent R&D and AI-Immunology progress. as mentioned msd exercised their option on evx-b3 we presented two-year clinical outcome data from our evx-01 phase ii study and we have announced the addition of evx-04 to our pipeline and evx-04 is the lead candidate for our precision cancer vaccine and looking ahead we are expecting to provide further r&d and business development updates so let's shift focus to our recent r&d and ai-immunology progress EVX-04 is our novel AI-designed cancer vaccine candidate targeting non-conventional antigens from the dark genome, so-called endogenous retroviruses or ERVs. evx-04 is our novel ai-designed cancer vaccine candidate targeting non-conventional antigens from the dark genome so-called endogenous retroviruses or ervs And these ERVs are specifically expressed in cancers predominant in normal tissue, making them an attractive target for cancer vaccines. and these ervs are specifically expressed in cancers predominant in normal tissue making them an attractive target for cancer vaccines EVX-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia, where we know relapses remain a major challenge. evx-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia where we know relapses remain a major challenge The vaccine is based on our AI-immunology platform, leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that match the ERV expression profile and also the immune characteristics in patients, and we have now designed the lead candidate and have conducted preclinical studies. Next steps include GMP manufacturing and additional R&D enabling studies to prepare for a first-in-human study. With the EVX-01 lead vaccine candidate selected, the program has been added to our pipeline. Further changes include the removal of the EVX-02 program, as we do not have any active development currently ongoing on this program. The EVX-02 vaccine program served as proof of concept for DNA delivery of neoantigen and has informed on the design of both EVX-03 and EVX-04. The vaccine is based on our AI- immunology platform, leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that match the ERV expression profile and also the immune characteristics in patients, and we have now designed the lead candidate and have conducted preclinical studies. the vaccine is based on our ai- immunology platform leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that match the erv expression profile and also the immune characteristics in patients and we have now designed the lead candidate and have conducted preclinical studies Next steps include GMP manufacturing and additional R&D enabling studies to prepare for a first-in-human study. next steps include gmp manufacturing and additional r&d enabling studies to prepare for a first-in-human study With the EVX-01 lead vaccine candidate selected, the program has been added to our pipeline. with the evx-01 lead vaccine candidate selected the program has been added to our pipeline Further changes include the removal of the EVX-02 program, as we do not have any active development currently ongoing on this program. further changes include the removal of the evx-02 program as we do not have any active development currently ongoing on this program The EVX-02 vaccine program served as proof of concept for DNA delivery of neo antigen and has informed on the design of both EVX-03 and EVX-04. the evx-02 vaccine program served as proof of concept for dna delivery of neo antigen and has informed on the design of both evx-03 and evx-04 Our lead program, EVX-01, is a personalized cancer vaccine that includes multiple patient-specific targets, so-called neoantigens, that we identify with our AI-Immunology platform from patient tumor material. EVX-01 is administered in combination with pembrolizumab, an immune checkpoint inhibitor, to enhance the clinical efficacy. In October, we presented two-year clinical outcome data from our phase II trial in an oral session at the ESMO Congress. The results are highly encouraging and were received well by the scientific and medical community. At the congress, we reported a 75% objective overall response. We also saw that 11 out of 12 patients that responded had a sustained response at two-year mark. We also saw a 34% conversion rate, meaning that patients with stable disease or partial response deepened their response upon EVX-01 treatment. Our lead program, EVX-01, is a personalized cancer vaccine that includes multiple patient-specific targets, so-called neo antigens, that we identify with our AI-Immunology platform from patient tumor material. our lead program evx-01 is a personalized cancer vaccine that includes multiple patient-specific targets so-called neo antigens that we identify with our ai-immunology platform from patient tumor material EVX-01 is administered in combination with pembrolizumab, an immune checkpoint inhibitor, to enhance the clinical efficacy. evx-01 is administered in combination with pembrolizumab an immune checkpoint inhibitor to enhance the clinical efficacy In October, we presented two-year clinical outcome data from our phase II trial in an oral session at the ESMO Congress. in october we presented two-year clinical outcome data from our phase ii trial in an oral session at the esmo congress The results are highly encouraging and were received well by the scientific and medical community. the results are highly encouraging and were received well by the scientific and medical community At the congress, we reported a 75% objective overall response. at the congress we reported a 75% objective overall response We also saw that 11 out of 12 patients that responded had a sustained response at two-year mark. we also saw that 11 out of 12 patients that responded had a sustained response at two-year mark We also saw a 34% conversion rate, meaning that patients with stable disease or partial response deepened their response upon EVX-01 treatment. we also saw a 34% conversion rate meaning that patients with stable disease or partial response deepened their response upon evx-01 treatment So, we find the clinical outcome data very encouraging, and further, we believe that they compare favorably to historical pembrolizumab therapy data. Equally encouraging is the strong immunological activity of EVX-01, which is critical for long-term efficacy. So, in all patients treated with EVX-01, we saw a neoantigen-specific T-cell response. Further, when assessing the individual neoantigen immune responses, we demonstrated that 81% of the vaccine neoantigens administered across patients were immunogenic. So, this high hit rate provides strong evidence of the predictive power of our AI-immunology platform. We also showed that the immune responses were sustained throughout the two-year trial period. Even after the dosing period ended, T-cell activity remained high, indicating lasting immune memory. And durable T-cell responses are essential for preventing relapses and in achieving long-term control of melanoma. So, we find the clinical outcome data very encouraging, and further, we believe that they compare favorably to historical pembrolizumab therapy data. so we find the clinical outcome data very encouraging and further we believe that they compare favorably to historical pembrolizumab therapy data Equally encouraging is the strong immunological activity of EVX-01, which is critical for long-term efficacy. equally encouraging is the strong immunological activity of evx-01 which is critical for long-term efficacy So, in all patients treated with EVX-01, we saw a neo antigen-specific T-cell response. so in all patients treated with evx-01 we saw a neo antigen-specific t-cell response Further, when assessing the individual neo antigen immune responses, we demonstrated that 81% of the vaccine neo antigens administered across patients were immunogenic. further when assessing the individual neo antigen immune responses we demonstrated that 81% of the vaccine neo antigens administered across patients were immunogenic So, this high hit rate provides strong evidence of the predictive power of our AI- immunology platform. so this high hit rate provides strong evidence of the predictive power of our ai- immunology platform We also showed that the immune responses were sustained throughout the two-year trial period. we also showed that the immune responses were sustained throughout the two-year trial period Even after the dosing period ended, T-cell activity remained high, indicating lasting immune memory. even after the dosing period ended t-cell activity remained high indicating lasting immune memory And durable T-cell responses are essential for preventing relapses and in achieving long-term control of melanoma. and durable t-cell responses are essential for preventing relapses and in achieving long-term control of melanoma This reinforces the potential of EVX-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with a standard of care, but also builds on a robust immune defense. As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development timelines. It enables us to optimize vaccine candidates with high precision, both for new and approved vaccines. From data input to candidate generation, the process is now fully automated, ensuring optimal sequence and conformation of vaccine targets. As mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. Further, it seamlessly connects the downstream processes, supporting a smooth transition from design to production. The design module has already been applied in some of our key R&D projects. This reinforces the potential of EVX-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with a standard of care, but also builds on a robust immune defense. this reinforces the potential of evx-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with a standard of care but also builds on a robust immune defense As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development timelines. as mentioned our ai platform has been enhanced with a new automated vaccine design module significantly reducing design time and also accelerating development timelines It enables us to optimize vaccine candidates with high precision, both for new and approved vaccines. it enables us to optimize vaccine candidates with high precision both for new and approved vaccines From data input to candidate generation, the process is now fully automated, ensuring optimal sequence and conformation of vaccine targets. from data input to candidate generation the process is now fully automated ensuring optimal sequence and conformation of vaccine targets As mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. as mentioned the new module speeds up vaccine development while reducing costs compared to traditional methods Further, it seamlessly connects the downstream processes, supporting a smooth transition from design to production. further it seamlessly connects the downstream processes supporting a smooth transition from design to production The design module has already been applied in some of our key R&D projects. the design module has already been applied in some of our key r&d projects Our first example is the use of the module to identify and select regions of an antigen that can be expressed. We noticed that the full length of a particular antigen could not be expressed due to solubility constraints. When we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen. Another example of the application is that we can, with the module, predict most optimal sequences of a vaccine target based on a given antigen protein structure. Here, we have also been able to rescue a hard-to-express protein that would require labor-intensive and trial-and-error design approaches to find expressible constructs. With this new design module, it positioned us at the forefront of AI-driven vaccine innovation and further enabled us to move fast from target discovery to final product candidate. Our first example is the use of the module to identify and select regions of an antigen that can be expressed. our first example is the use of the module to identify and select regions of an antigen that can be expressed We noticed that the full length of a particular antigen could not be expressed due to solubility constraints. we noticed that the full length of a particular antigen could not be expressed due to solubility constraints When we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen. when we applied the new module we identified truncated variants of the antigens that then could be expressed opening for preclinical evaluation of that antigen Another example of the application is that we can, with the module, predict most optimal sequences of a vaccine target based on a given antigen protein structure. another example of the application is that we can with the module predict most optimal sequences of a vaccine target based on a given antigen protein structure Here, we have also been able to rescue a hard-to-express protein that would require labor-intensive and trial-and-error design approaches to find expressible constructs. here we have also been able to rescue a hard-to-express protein that would require labor-intensive and trial-and-error design approaches to find expressible constructs With this new design module, it positioned us at the forefront of AI-driven vaccine innovation and further enabled us to move fast from target discovery to final product candidate. with this new design module it positioned us at the forefront of ai-driven vaccine innovation and further enabled us to move fast from target discovery to final product candidate So, in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. And we look forward to updating you as our programs continue to advance. So, with that, I would like to give the word to Thomas to present the financial results. So, in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. so in summary we have seen significant progress across our r&d pipeline and ai platform and we are on track for the next milestones And we look forward to updating you as our programs continue to advance. and we look forward to updating you as our programs continue to advance So, with that, I would like to give the word to Thomas to present the financial results. so with that i would like to give the word to thomas to present the financial results

Speaker 2: Yes, thank you, Birgitte. I am happy to present the financial results for the quarter. And maybe let me just start with an overview of the achievements that we have done throughout the year up until now, based on strong execution of our financial strategy. As we can see here on the slide also, throughout the year, we have made a number of activities with capital market activities, with, of course, also the agreement that we did with the European Investment Bank of debt conversion, plus also MSD out-licensing of the EVX-B3. Yes, thank you, Birgitte. yes thank you birgitte I am happy to present the financial results for the quarter. i am happy to present the financial results for the quarter And maybe let me just start with an overview of the achievements that we have done throughout the year up until now, based on strong execution of our financial strategy. and maybe let me just start with an overview of the achievements that we have done throughout the year up until now based on strong execution of our financial strategy As we can see here on the slide also, throughout the year, we have made a number of activities with capital market activities, with, of course, also the agreement that we did with the European Investment Bank of debt conversion, plus also MSD out-licensing of the EVX-B3. as we can see here on the slide also throughout the year we have made a number of activities with capital market activities with of course also the agreement that we did with the european investment bank of debt conversion plus also msd out-licensing of the evx-b3 So, throughout the year and up until the end of October, we have activities to the amount of $31.8 million, all which basically helps strengthen our equity and certainly also our runway, which is now extended into the second half of 2027. So, really a good and strong achievement and following the financial strategy that we have laid out. If we zoom in on the third quarter and the highlights from the third quarter, we certainly have had a strong financial quarterly performance. As mentioned, the cash runway now has been extended into the second half of 2027. And we've also seen in the quarter the option exercised by Merck or MSD, which not only provides cash income now, but also has a future revenue income of potentially up to $592 million. So, throughout the year and up until the end of October, we have activities to the amount of $31.8 million, all which basically helps strengthen our equity and certainly also our runway, which is now extended into the second half of 2027. so throughout the year and up until the end of october we have activities to the amount of $31.8 million all which basically helps strengthen our equity and certainly also our runway which is now extended into the second half of 2027 So, really a good and strong achievement and following the financial strategy that we have laid out. so really a good and strong achievement and following the financial strategy that we have laid out If we zoom in on the third quarter and the highlights from the third quarter, we certainly have had a strong financial quarterly performance. if we zoom in on the third quarter and the highlights from the third quarter we certainly have had a strong financial quarterly performance As mentioned, the cash runway now has been extended into the second half of 2027. as mentioned the cash runway now has been extended into the second half of 2027 And we've also seen in the quarter the option exercised by Merck or MSD, which not only provides cash income now, but also has a future revenue income of potentially up to $592 million. and we've also seen in the quarter the option exercised by merck or msd which not only provides cash income now but also has a future revenue income of potentially up to $592 million We are well on track also in the third quarter on delivering on our financial targets for the full year, and throughout the quarter, we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income, so really a good and strong quarter. If we look a little bit closer on the profit and loss element of it, clearly the revenue from MSD drives the quarterly operational gain, the first of its kind for Evaxion, but also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter, so also from earlier communications, we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level. We are well on track also in the third quarter on delivering on our financial targets for the full year, and throughout the quarter, we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income, so really a good and strong quarter. we are well on track also in the third quarter on delivering on our financial targets for the full year and throughout the quarter we have also really solidified our equity through the european investment bank debt conversion and also through the msd income so really a good and strong quarter If we look a little bit closer on the profit and loss element of it, clearly the revenue from MSD drives the quarterly operational gain, the first of its kind for Evaxion, but also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter, so also from earlier communications, we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level. if we look a little bit closer on the profit and loss element of it clearly the revenue from msd drives the quarterly operational gain the first of its kind for evaxion but also importantly our operating expenses not only do we manage those well but we actually also are slightly below last year and more or less at the same level as previous quarter so also from earlier communications we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level Net financials in the quarter is to the tune of $1.3 million, driven by the debt conversion that we did in July. The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10th. That premium has been recorded on the financial income for the quarter, and that then brings the income for the quarter to $4.6 million. Turning to the balance sheet, we certainly, as mentioned already, have continued the strong execution that also has improved our equity. The equity now stands at the end of the quarter at $16.6 million. Included in the equity is a derivative liability with a net impact of $1.5 million. The derivative stems from our public offering in January and the investor warrants that we had from that date. Net financials in the quarter is to the tune of $1.3 million, driven by the debt conversion that we did in July. net financials in the quarter is to the tune of $1.3 million driven by the debt conversion that we did in july The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10th. the debt conversion in july with the eib happened at an 89% share price premium at the market close of july 10th That premium has been recorded on the financial income for the quarter, and that then brings the income for the quarter to $4.6 million. that premium has been recorded on the financial income for the quarter and that then brings the income for the quarter to $4.6 million Turning to the balance sheet, we certainly, as mentioned already, have continued the strong execution that also has improved our equity. turning to the balance sheet we certainly as mentioned already have continued the strong execution that also has improved our equity The equity now stands at the end of the quarter at $16.6 million. the equity now stands at the end of the quarter at $16.6 million Included in the equity is a derivative liability with a net impact of $1.5 million. included in the equity is a derivative liability with a net impact of $1.5 million The derivative stems from our public offering in January and the investor warrants that we had from that date. the derivative stems from our public offering in january and the investor warrants that we had from that date However, in October, we have seen, as mentioned already, warrant exercises of 2.7 million, which means that this net impact of the derivative will be at a minimal value at the end of the year, so also a good outcome. It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrant of 2.8 million. Also, important to note is that our cash balance end of June is at a sound and solid $10.6 million, and we'll see further cash income as we or cash flow in as we received in October, the revenue income from MSD and also the cash from the sales of shares due to the investor warrant exercise. However, in October, we have seen, as mentioned already, warrant exercises of 2.7 million, which means that this net impact of the derivative will be at a minimal value at the end of the year, so also a good outcome. however in october we have seen as mentioned already warrant exercises of 2.7 million which means that this net impact of the derivative will be at a minimal value at the end of the year so also a good outcome It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrant of 2.8 million. it's also reduced our outstanding warrants by 1 million adss and we now have a remaining outstanding warrant of 2.8 million Also, important to note is that our cash balance end of June is at a sound and solid $10.6 million, and we'll see further cash income as we or cash flow in as we received in October, the revenue income from MSD and also the cash from the sales of shares due to the investor warrant exercise. also important to note is that our cash balance end of june is at a sound and solid $10.6 million and we'll see further cash income as we or cash flow in as we received in october the revenue income from msd and also the cash from the sales of shares due to the investor warrant exercise And last but not least, the debt conversion to equity conversion with the European Investment Bank really has strengthened our balance sheet, has improved our cash flow as we move forward, and has certainly also lowered our leverage. So, really a great outcome from that event also. So, a good solid quarter following along our financial strategy. And with that, I then hand it back to Birgitte. And last but not least, the debt conversion to equity conversion with the European Investment Bank really has strengthened our balance sheet, has improved our cash flow as we move forward, and has certainly also lowered our leverage. and last but not least the debt conversion to equity conversion with the european investment bank really has strengthened our balance sheet has improved our cash flow as we move forward and has certainly also lowered our leverage So, really a great outcome from that event also. so really a great outcome from that event also So, a good solid quarter following along our financial strategy. so a good solid quarter following along our financial strategy And with that, I then hand it back to Birgitte. and with that i then hand it back to birgitte

Speaker 4: Thank you, Thomas. So, lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority, and multiple parallel partnership discussions are currently ongoing. Cash runway is extended to the second half of 2027. Thank you, Thomas. thank you thomas So, lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. so lastly as conclusive remarks i would like to highlight that we do have a strong operational momentum We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. we have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts Business development remains a key priority, and multiple parallel partnership discussions are currently ongoing. business development remains a key priority and multiple parallel partnership discussions are currently ongoing Cash runway is extended to the second half of 2027. cash runway is extended to the second half of 2027 And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. Please follow the operators' instructions. Thank you. And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. and with that i would like to thank you for your time and attention and we'll be happy to answer any questions Please follow the operators' instructions. please follow the operators' instructions Thank you. thank you

Speaker 1: Thank you. As a reminder, if you wish to ask a question, please press star one one on your telephone and wait for your name to be announced. To withdraw your question, press star one one again. Please stand by while we prepare the first question. First question comes from Soumit Roy at JonesTrading. Your line is open. Please go ahead. Thank you. thank you As a reminder, if you wish to ask a question, please press star one one on your telephone and wait for your name to be announced. as a reminder if you wish to ask a question please press star one one on your telephone and wait for your name to be announced To withdraw your question, press star one one again. to withdraw your question press star one one again Please stand by while we prepare the first question. please stand by while we prepare the first question First question comes from Soumit Roy at JonesTrading. first question comes from soumit roy at jonestrading Your line is open. your line is open Please go ahead. please go ahead

Speaker 6: Good morning, everyone, and congratulations on all the progress this quarter. A quick question on the EVX-01. If you can give us any color on the potential partnership deal, what is the key question that you're getting from a partner? Good morning, everyone, and congratulations on all the progress this quarter. good morning everyone and congratulations on all the progress this quarter A quick question on the EVX-01. a quick question on the evx-01 If you can give us any color on the potential partnership deal, what is the key question that you're getting from a partner? if you can give us any color on the potential partnership deal what is the key question that you're getting from a partner Do they want to wait for much longer-term data or any other key achievements you have to present for a successful deal? Do they want to wait for much longer-term data or any other key achievements you have to present for a successful deal? do they want to wait for much longer-term data or any other key achievements you have to present for a successful deal Yeah, thank you for that question. So, we just presented, as mentioned, the two-year clinical outcome data. And I would say that we have moved from questions around quality of data, how does your platform work, to more, how can we apply your technology within perhaps other types of cancer indications. So, the data was received well, and we have been discussing it with key opinion leaders. We have also been discussing it with potential partners. And the strategy is that we will out-license it at the current development stage, and then the partner can, of course, decide on potential next steps. Yeah, thank you for that question. yeah thank you for that question So, we just presented, as mentioned, the two-year clinical outcome data. so we just presented as mentioned the two-year clinical outcome data And I would say that we have moved from questions around quality of data, how does your platform work, to more, how can we apply your technology within perhaps other types of cancer indications. and i would say that we have moved from questions around quality of data how does your platform work to more how can we apply your technology within perhaps other types of cancer indications So, the data was received well, and we have been discussing it with key opinion leaders. so the data was received well and we have been discussing it with key opinion leaders We have also been discussing it with potential partners. we have also been discussing it with potential partners And the strategy is that we will out-license it at the current development stage, and then the partner can, of course, decide on potential next steps. and the strategy is that we will out-license it at the current development stage and then the partner can of course decide on potential next steps If we continue on the track we are currently with advanced melanoma, the next most likely step would be to conduct a larger randomized control arm study comparing the combination of EVX-01 plus standard of care to standard of care alone, so that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden, meaning that we can select high-quality new antigens and formulate a vaccine that would benefit the patient, so multiple different discussions are ongoing, and also different questions are coming our way, but generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward together and find solutions for manufacturing and also for other indications. If we continue on the track we are currently with advanced melanoma, the next most likely step would be to conduct a larger randomized control arm study comparing the combination of EVX-01 plus standard of care to standard of care alone, so that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden, meaning that we can select high-quality new antigens and formulate a vaccine that would benefit the patient, so multiple different discussions are ongoing, and also different questions are coming our way, but generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward together and find solutions for manufacturing and also for other indications. if we continue on the track we are currently with advanced melanoma the next most likely step would be to conduct a larger randomized control arm study comparing the combination of evx-01 plus standard of care to standard of care alone so that's at least one option but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden meaning that we can select high-quality new antigens and formulate a vaccine that would benefit the patient so multiple different discussions are ongoing and also different questions are coming our way but generally the questions are not about the quality of the data or the impact of the data but more how can we move this forward together and find solutions for manufacturing and also for other indications Got it. Thank you. Got it. got it Thank you. thank you Thank you for that. One last question. Congrats on unveiling the EVX-04 in the AML program. If you can give us a slight understanding on the target or how is it expressed on AML stem cells? CD33, CD123 have been tried, and trying to understand what is the differentiation from this target. Thank you for that. thank you for that One last question. one last question Congrats on unveiling the EVX-04 in the AML program. congrats on unveiling the evx-04 in the aml program If you can give us a slight understanding on the target or how is it expressed on AML stem cells? if you can give us a slight understanding on the target or how is it expressed on aml stem cells CD33, CD123 have been tried, and trying to understand what is the differentiation from this target. cd33 cd123 have been tried and trying to understand what is the differentiation from this target

Speaker 4: Yeah. No, this is a very good question. So, the way that we have applied our AI-Immunology platform is that we look at genomic and transcriptomic data. And for this particular type of antigens, we mainly look at transcriptomic data. So, the sequences that are being expressed as messenger RNA or RNA in general in the tumors. And then we started out by actually analyzing several different types of novel classes of antigens. Yeah. yeah No, this is a very good question. no this is a very good question So, the way that we have applied our AI-Immunology platform is that we look at genomic and transcriptomic data. so the way that we have applied our ai-immunology platform is that we look at genomic and transcriptomic data And for this particular type of antigens, we mainly look at transcriptomic data. and for this particular type of antigens we mainly look at transcriptomic data So, the sequences that are being expressed as messenger RNA or RNA in general in the tumors. so the sequences that are being expressed as messenger rna or rna in general in the tumors And then we started out by actually analyzing several different types of novel classes of antigens. and then we started out by actually analyzing several different types of novel classes of antigens And we realized that in certain indications, and AML is one of them, there's a very high expression level of these endogenous retroviral sequences from the dark genome, meaning that we can, across patients, find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine. So, this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients. But we're still using AI-Immunology and our core technology to identify the most optimal antigens. Now it's just coming from the dark genome. And we realized that in certain indications, and AML is one of them, there's a very high expression level of these endogenous retroviral sequences from the dark genome, meaning that we can, across patients, find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine. and we realized that in certain indications and aml is one of them there's a very high expression level of these endogenous retroviral sequences from the dark genome meaning that we can across patients find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine So, this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients. so this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients But we're still using AI-Immunology and our core technology to identify the most optimal antigens. but we're still using ai-immunology and our core technology to identify the most optimal antigens Now it's just coming from the dark genome. now it's just coming from the dark genome

Speaker 6: Got it. Thank you so much, and congratulations again on the progress. Got it. got it Thank you so much, and congratulations again on the progress. thank you so much and congratulations again on the progress

Speaker 4: Thank you. Thank you. thank you

Speaker 1: Thank you. Please stand by for your next question. The next question comes from Nelson Cox at Lake Street Capital. Your line is open. Thank you. thank you Please stand by for your next question. please stand by for your next question The next question comes from Nelson Cox at Lake Street Capital. the next question comes from nelson cox at lake street capital Your line is open. your line is open Please go ahead. Please go ahead. please go ahead

Speaker 5: Hey, Nelson on for Thomas. Congrats on all the progress here this quarter. I'll maybe ask my two upfront apologies if I've kind of missed some of this. I've had some technical issues, but a lot of updates here as of late. Maybe at a high level, can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? And then when you look at the proportion of your business development conversations you're having today, can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline? Thanks. Hey, Nelson on for Thomas. hey nelson on for thomas Congrats on all the progress here this quarter. congrats on all the progress here this quarter I'll maybe ask my two upfront apologies if I've kind of missed some of this. i'll maybe ask my two upfront apologies if i've kind of missed some of this I've had some technical issues, but a lot of updates here as of late. i've had some technical issues but a lot of updates here as of late Maybe at a high level, can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? maybe at a high level can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year And then when you look at the proportion of your business development conversations you're having today, can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline? and then when you look at the proportion of your business development conversations you're having today can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline Thanks. thanks

Speaker 4: Yeah, hi Thomas. Thank you for that question. Yeah, hi Thomas. yeah hi thomas Thank you for that question. thank you for that question So, we do have multiple dialogues ongoing, and I would say that the interest is across our R&D pipeline, but also centered around our capabilities for identifying novel targets, so classical target discovery programs. There's interest in our oncology programs, and there's also interest in our infectious disease programs. It's a little bit mixed, I would say, and some companies do have preferences in infectious disease. Some do have interest in both vaccine candidates that we have developed and in target discovery collaborations, so a little bit of mix, and that confirms, I would say, our strategy to monetize on both our own in-house developed vaccine candidates, but also to enter into target discovery collaborations. I cannot comment so much on exactly where we are, as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal. So, we do have multiple dialogues ongoing, and I would say that the interest is across our R&D pipeline, but also centered around our capabilities for identifying novel targets, so classical target discovery programs. so we do have multiple dialogues ongoing and i would say that the interest is across our r&d pipeline but also centered around our capabilities for identifying novel targets so classical target discovery programs There's interest in our oncology programs, and there's also interest in our infectious disease programs. there's interest in our oncology programs and there's also interest in our infectious disease programs It's a little bit mixed, I would say, and some companies do have preferences in infectious disease. it's a little bit mixed i would say and some companies do have preferences in infectious disease Some do have interest in both vaccine candidates that we have developed and in target discovery collaborations, so a little bit of mix, and that confirms, I would say, our strategy to monetize on both our own in-house developed vaccine candidates, but also to enter into target discovery collaborations. some do have interest in both vaccine candidates that we have developed and in target discovery collaborations so a little bit of mix and that confirms i would say our strategy to monetize on both our own in-house developed vaccine candidates but also to enter into target discovery collaborations I cannot comment so much on exactly where we are, as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal. i cannot comment so much on exactly where we are as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal But a lot of activities, and we can see that the interest is increasing when we have major data readouts, as we have had in this last quarter with the EVX-01 phase II data coming out. But a lot of activities, and we can see that the interest is increasing when we have major data readouts, as we have had in this last quarter with the EVX-01 phase II data coming out. but a lot of activities and we can see that the interest is increasing when we have major data readouts as we have had in this last quarter with the evx-01 phase ii data coming out

Speaker 5: Great. Thanks for taking questions. Great. great Thanks for taking questions. thanks for taking questions

Speaker 1: Please stand by for your next question. As a reminder, if you do have a question, please press star one one on your telephone. The next question comes from Swayampakula Ramakanth at H.C. Wainwright. Your line is open. Please go ahead. Please stand by for your next question. please stand by for your next question As a reminder, if you do have a question, please press star one one on your telephone. as a reminder if you do have a question please press star one one on your telephone The next question comes from Swayampakula Ramakanth at H.C. the next question comes from swayampakula ramakanth at h.c Wainwright. wainwright Your line is open. your line is open Please go ahead. please go ahead

Speaker 3: Thank you. Thank you. This is RK from H.C. Wainwright. Good afternoon, Birgitte and team. Thank you. thank you Thank you. thank you This is RK from H.C. this is rk from h.c Wainwright. wainwright Good afternoon, Birgitte and team. good afternoon birgitte and team

Speaker 4: Hi. Hi. hi

Speaker 3: So, certainly, there are very interesting developments going on at the company. So, can we focus for a second on your automated design module, which is yet another interesting AI design drug design module that you have? So, how should we think about this? So, certainly, there are very interesting developments going on at the company. so certainly there are very interesting developments going on at the company So, can we focus for a second on your automated design module, which is yet another interesting AI design drug design module that you have? so can we focus for a second on your automated design module which is yet another interesting ai design drug design module that you have So, how should we think about this? so how should we think about this Is this something that can help your internal designing I mean, designing of your internal molecules only, or is this up for entering into partnerships, or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules? It looks like there's a lot of places where this thing could go. And what are your thoughts on that? Is this something that can help your internal designing I mean, designing of your internal molecules only, or is this up for entering into partnerships, or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules? is this something that can help your internal designing i mean designing of your internal molecules only or is this up for entering into partnerships or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules It looks like there's a lot of places where this thing could go. it looks like there's a lot of places where this thing could go And what are your thoughts on that? and what are your thoughts on that

Speaker 4: Yes, you're absolutely right. It can go in multiple directions. So, in the past, we have used AI-Immunology to identify novel vaccine targets. And then these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. And this process has been labor-intensive. So, the ambition was to set up an automated process for this. Yes, you're absolutely right. yes you're absolutely right It can go in multiple directions. it can go in multiple directions So, in the past, we have used AI-Immunology to identify novel vaccine targets. so in the past we have used ai-immunology to identify novel vaccine targets And then these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. and then these targets have then been undergoing manual processing ensuring that we could also express them and manufacture them And this process has been labor-intensive. and this process has been labor-intensive So, the ambition was to set up an automated process for this. so the ambition was to set up an automated process for this We have now been able to launch a new module where several different AI tools are being integrated, enabling us to go from target discovery to product candidate selection very fast. So, that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or, in general, key targets, that these antigens or targets can also be produced in a cost-effective way. So, I do see multiple options for monetizing on this new module. We have now been able to launch a new module where several different AI tools are being integrated, enabling us to go from target discovery to product candidate selection very fast. we have now been able to launch a new module where several different ai tools are being integrated enabling us to go from target discovery to product candidate selection very fast So, that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or, in general, key targets, that these antigens or targets can also be produced in a cost-effective way. so that can of course be applied to our own programs but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or in general key targets that these antigens or targets can also be produced in a cost-effective way So, I do see multiple options for monetizing on this new module. so i do see multiple options for monetizing on this new module

Speaker 3: Okay. So, and then coming into the real world and talk about EVX-01 for another minute. At ESMO, you are planning to present some additional data from the ongoing trial. Okay. okay So, and then coming into the real world and talk about EVX-01 for another minute. so and then coming into the real world and talk about evx-01 for another minute At ESMO, you are planning to present some additional data from the ongoing trial. at esmo you are planning to present some additional data from the ongoing trial What sort of data would come out from there, and how would it strengthen your narrative on EVX-01, not only for yourselves but also for a potential partner, whether it is just on the drug or on the platform, just as you were talking about when you were answering, Soumit Roy? What sort of data would come out from there, and how would it strengthen your narrative on EVX-01, not only for yourselves but also for a potential partner, whether it is just on the drug or on the platform, just as you were talking about when you were answering, Soumit Roy? what sort of data would come out from there and how would it strengthen your narrative on evx-01 not only for yourselves but also for a potential partner whether it is just on the drug or on the platform just as you were talking about when you were answering soumit roy

Speaker 4: Yeah. So, at ESMO, we presented the clinical outcome data, and we are still in the process of analyzing patient samples. So, we have collected blood samples before therapy, during vaccination, and then also as follow-up samples. And all of these samples from the patients are currently being assessed in our own lab. So, we do, of course, monitoring of the EVX-01-induced T-cell responses, but we also do deeper phenotypic analysis. So, some of this will go out at SITC. Yeah. yeah So, at ESMO, we presented the clinical outcome data, and we are still in the process of analyzing patient samples. so at esmo we presented the clinical outcome data and we are still in the process of analyzing patient samples So, we have collected blood samples before therapy, during vaccination, and then also as follow-up samples. so we have collected blood samples before therapy during vaccination and then also as follow-up samples And all of these samples from the patients are currently being assessed in our own lab. and all of these samples from the patients are currently being assessed in our own lab So, we do, of course, monitoring of the EVX-01-induced T-cell responses, but we also do deeper phenotypic analysis. so we do of course monitoring of the evx-01-induced t-cell responses but we also do deeper phenotypic analysis So, some of this will go out at SITC. so some of this will go out at sitc We have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients, so more to come, more deep dives into the immune profiles of the cells collected from the patients, and then we also have the extension phase of the EVX-01 trial, where six patients are now receiving EVX-01 as a monotherapy, so more data will come from this subset of patients. We have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients, so more to come, more deep dives into the immune profiles of the cells collected from the patients, and then we also have the extension phase of the EVX-01 trial, where six patients are now receiving EVX-01 as a monotherapy, so more data will come from this subset of patients. we have a poster presentation but also at future conferences because we have not analyzed all the many samples that have been collected from the patients so more to come more deep dives into the immune profiles of the cells collected from the patients and then we also have the extension phase of the evx-01 trial where six patients are now receiving evx-01 as a monotherapy so more data will come from this subset of patients

Speaker 3: Perfect. Thank you for that, and then my last question is on the MSD relationship. Perfect. perfect Thank you for that, and then my last question is on the MSD relationship. thank you for that and then my last question is on the msd relationship I mean, it's great to have the $7.5 million, but how much more do you still need to give any additional data for the second molecule, or is it the Merck still has to complete their due diligence on the data that you're giving them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million? I mean, it's great to have the $7.5 million, but how much more do you still need to give any additional data for the second molecule, or is it the Merck still has to complete their due diligence on the data that you're giving them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million? i mean it's great to have the $7.5 million but how much more do you still need to give any additional data for the second molecule or is it the merck still has to complete their due diligence on the data that you're giving them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million

Speaker 4: Yeah. So, for EVX-B2, MSD is currently evaluating the data that we have provided, and further, they are in the process of generating some confirmatory analysis, and that was also why the evaluation period was extended, so we expect that they will come back with an answer in the second or in the first half of next year. Perfect. The process is ongoing, and it's, of course, very exciting, and we would love to out-license EVX-B2 to MSD. Yeah. yeah So, for EVX-B2, MSD is currently evaluating the data that we have provided, and further, they are in the process of generating some confirmatory analysis, and that was also why the evaluation period was extended, so we expect that they will come back with an answer in the second or in the first half of next year. so for evx-b2 msd is currently evaluating the data that we have provided and further they are in the process of generating some confirmatory analysis and that was also why the evaluation period was extended so we expect that they will come back with an answer in the second or in the first half of next year Perfect. perfect The process is ongoing, and it's, of course, very exciting, and we would love to out-license EVX-B2 to MSD. the process is ongoing and it's of course very exciting and we would love to out-license evx-b2 to msd

Speaker 3: Yeah. Okay. Great. Thank you. Yeah. yeah Okay. okay Great. great Thank you. thank you Thank you very much for taking all my questions. Thank you very much for taking all my questions. thank you very much for taking all my questions

Speaker 4: Thank you. Thank you. thank you

Speaker 1: Thank you. There are no further questions, so I shall hand back to you for final remarks. Thank you. thank you There are no further questions, so I shall hand back to you for final remarks. there are no further questions so i shall hand back to you for final remarks

Speaker 4: Yes, and thank you for joining us today, and please do not hesitate to reach out should you have any additional questions. Thank you. Y es, and thank you for joining us today, and please do not hesitate to reach out should you have any additional questions. y es and thank you for joining us today and please do not hesitate to reach out should you have any additional questions Thank you. thank you