NASDAQ:EVAX Evaxion Biotech A/S Q4 2024 Earnings Report $1.31 0.00 (-0.08%) Closing price 04/17/2025 03:59 PM EasternExtended Trading$1.27 -0.04 (-3.28%) As of 04/17/2025 06:01 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more. Earnings HistoryForecast Evaxion Biotech A/S EPS ResultsActual EPS-$0.07Consensus EPS -$0.26Beat/MissBeat by +$0.19One Year Ago EPSN/AEvaxion Biotech A/S Revenue ResultsActual Revenue$0.12 millionExpected Revenue$1.66 millionBeat/MissMissed by -$1.54 millionYoY Revenue GrowthN/AEvaxion Biotech A/S Announcement DetailsQuarterQ4 2024Date4/1/2025TimeBefore Market OpensConference Call DateTuesday, April 1, 2025Conference Call Time8:30AM ETUpcoming EarningsEvaxion Biotech A/S' Q1 2025 earnings is scheduled for Tuesday, May 27, 2025, with a conference call scheduled at 2:00 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Conference Call ResourcesConference Call AudioConference Call TranscriptPress Release (6-K)Annual Report (20-F)Earnings HistoryCompany ProfilePowered by Evaxion Biotech A/S Q4 2024 Earnings Call TranscriptProvided by QuartrApril 1, 2025 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Evaxion Biotech Business Update Full Year twenty twenty four Conference Call and Webcast. At this time, all participants will be in listen only mode. After the speakers' presentation, there will be a question and answer session. Please note that today's conference is being recorded. Operator00:00:33I would now like to hand the conference over to your speaker, Christian Kangstropp, CEO. Please go ahead. Speaker 100:00:40Thank you so much, and good morning, and good afternoon to all of you, and a very warm welcome to this Evaxion full year twenty twenty four business update call. I'm Christian Kansrup, CEO of Evaxion. With me today, I have Birgitte Roijnu, our chief science officer Thomas Smith, our chief financial officer and Mads Kronborg, our VP of Investor Relations and Communications. And I think it's fair to say that 2024 was a super exciting year for Evaxion with lots of achievements throughout the year, and we are looking very much forward to be giving you an update on the year. And the agenda and what we intend to cover. Speaker 100:01:28First of all, I will start out recapping on 2024, looking ahead into 2025 and some of the significant milestones that we see in front of us. Birgitte will be taking us through the R and D update. Thomas will cover the 2024 financial results. And I will be having a few concluding remarks before we, as usual, jump into the Q and A. And another thing that is, as usual, is the forward looking statements. Speaker 100:02:01We will be talking about the future. And of course, talking about the future entails uncertainties. Hence, I direct your attention to the forward looking statements slide on Slide number three. And with that, let's get into the agenda and start out with recapping on '24 and looking ahead. First of all, as I already said, I think it's fair to say 2024 was a year of substantial progress across Evaction. Speaker 100:02:31That goes for all parts of the business if we look at business development, if we look at R and D, if we look at our platform and also when we look at financing. I'm truly proud of what the team and the whole organization has achieved throughout the year. I think it's also fair to say that it has provided us with a very strong foundation going into 2025. But if we start out looking at business development here, of course, we entered into the transformational partnership with MSD in September 2024, a very important achievement for the year. And I'm also happy to say that we are tracking well towards potential option exercise in the second half of twenty twenty five. Speaker 100:03:19Begither will also be getting back to this. Also, I'm pleased to say that our current business development pipeline supports our ambition of at least two new agreements. Just to recap, we have a very strong focus on partnering as a way of realizing value of both our platform and pipeline. And of course, maintaining a business development pipeline, which can generate future partnerships is important to us. From an R and D point of view, we have continued the successful execution of the ongoing EVX-one Phase two trial. Speaker 100:03:55We presented convincing one year data in the fall of last year, '60 '9 percent overall response rate at the one year readout of the ongoing Phase II trial, and fifteen out of sixteen patients showing a reduction in tumor target lesions. Truly exciting data, which makes us look very much forward to the two year readout that we will be having in the second half of the year. What we have also done is established a completely new precision cancer vaccine concept deploying our AI immunology platform targeting nonconventional endogenous retroviruses, tumor antigens which are shared across patients. This is exciting because it broadens the potential of cancer vaccines. And a precision based approach is a very nice complement to our personalized cancer vaccine EVX-one, which has complemented it nicely. Speaker 100:04:57Looking at the platform, AI immunology, it's a core of our business. And of course, ensuring ongoing development and performance improvement of the platform is critical for staying off the forefront of AI derived development of novel medicines. And here I'm very pleased that we last year launched a novel toxin antigen predictor, which allows us for developing even better bacterial vaccines. This continuous improvement of both capabilities and the performance of AI immunology remains a priority to us. Last but not least, financing is, of course, an important factor in our business. Speaker 100:05:45And here, I'm pleased to say that we, by public offering and other capital market activities, have extended our cash at hand to mid-twenty twenty six. In addition to that, Merck or MSD Global Health Innovation Fund have invested in us for the third time, now holding a close to 20% equity stake. We are very pleased about the strong relationship we have with the Merck or MSD Global Health Innovation Fund and are pleased to see the continued and ongoing support and, of course, welcome them as a significant shareholder in Evaxion. If we then turn to the next slide and look ahead, we have quite significant value triggers coming up throughout the year. I'm also pleased to say that we already delivered on our first milestone for the year, which is the all patients completing dosing in the EBX-one trial. Speaker 100:06:43What we also will be presenting later on this month, actually, at the AACR meeting is additional EBX-one data. Looking into the second half, a number of significant milestones here. The MSD Maxine collaboration and the decision on option exercise is expected in the second half, could generate up to $10,000,000 in income to Evaction if MSD exercises the options to both. Needless to say, a very important milestone for us. And also, as I already mentioned, pleased to see that collaboration is on track. Speaker 100:07:24Then we will have the two year readout on EVX-one in the second half of the year as well. With a strong one year readout, we are very much looking forward to that. We will be selecting lead antigens for our CMV vaccine candidate, which now is a fully owned candidate, which we also are looking forward to. And then building on the Precision vaccine concept comments I had just before, we will be selecting lead vaccine candidate in the second half as well. Throughout the year, two other significant milestones: business development. Speaker 100:08:06We have the ambition of generating at least two new agreements in 2025 and are working hard towards that. And continuing building our pipeline is also a priority with a multi partner approach, partnering around existing pipeline candidates just as we included the EVXB2 in the collaboration with MSD, then we need to continue to build the pipeline with novel candidates in order to ensure that we have an attractive and broad pipeline of novel vaccine candidates, which we can partner via our multi partner approach. Here, we have the target of two new pipeline candidates within infectious diseases, one in the first half and one in the second half. Also here, pleased to say that we are well on track towards meeting that. Just a very quick recap on our focus. Speaker 100:09:06Our focus is on deriving value from both our platform and our pipeline. And the unique nature here is the complementarity of having a dual focus on platform and pipeline, which is driven by the unique capabilities and properties of AI immunology and the multidisciplinary capabilities that we have built around our AI immunology platform. Focus of the platform, that is, to enter into high value, low risk partnerships around target discovery, design, and development of novel vaccine candidates. The MSD collaboration around EVHXB3 is a good example of that. And then it's, of course, also deploying the platform to expand and build our own pipeline, just as we have the target of these two new infectious disease candidates for the year. Speaker 100:10:01Pipeline, that is around advancing select high value programs into preclinical and early clinical development, leveraging our multidisciplinary capability base, and then pursue partnering at the right point in time. The partnering with MSC around EVX-two is a good example of what we want to do here. And of course, we have EBX-one in phase two development and very much looking forward to the clinical data readout later on this year. So focusing on both platform and pipeline, but being able to do so in a cost effective way via the unique features of the AI immunology platform and the multidisciplinary capabilities we have around that. We are confident that this strategy will generate significant opportunities going forward and are executing in full focus on that. Speaker 100:11:00And then before handing over to Birgitte, I would just touch a little bit on a few recent events. In January, we completed a public offering. And together with other capital market activities, we have raised $17,000,000 this year, extending our cash runway to mid-twenty twenty six. As already mentioned, MSD, Global Health Innovation Fund participated in the offering. But what I'm also very pleased around is to see other healthcare focused investors in the public offering. Speaker 100:11:34With that offering, we have had a very nice expansion of our investor base and looking forward to continuing the collaboration with those investors we got in in that round. We have also communicated that we are in agreement and discussions with the European Investment Bank around conversion of €3,500,000 out of the €7,000,000 loan we have with ERP into an equity type instrument. Originally, we had communicated we expected that completed in the first quarter. We can see that some of the legal documentations takes longer to complete than anticipated, but now we are expecting to complete this in the second quarter. This will enable a significant simplification of our balance sheet and also save cost in terms of interest payments going forward. Speaker 100:12:28So we are looking forward to having that loan conversion converted into equity. We, in 2024, got a delisting determination from NASDAQ. We are very pleased to say that has been withdrawn here in the first quarter. We are now in full compliance with all NASDAQ listing requirements. Another thing that makes me proud and happy is the ongoing efforts in the whole organization in terms of optimizing our spend. Speaker 100:12:58And that has enabled us to have a 2025 operational cash burn at US14 million dollars which is the same level as 2024 despite an increased activity level. And this ongoing spend optimization is, of course, important because it allows us to do more while still being very cautious in how we spend our cash. Finally, also for the first quarter, EVX-one completed dosing. I already mentioned that. What we also have announced is that we have extended the EVX-one trial from two to three years. Speaker 100:13:37Important, this is not because we haven't seen good data or the data we expected. On the contrary, it's because we have seen very good data. And, we had the opportunity in a very cost effective way, given patients are in the trial, given we had EVX-one already produced, to extend the trial with one year at minimal cost. And this allows us to generate three year data on this truly novel personalized cancer vaccine, which will create for a very strong data package. So excited about that opportunity of expanding the trial, and Birgitte will also be getting back to that. Speaker 100:14:17And with that, Birgitte, I will hand over to you to give an update from an R and D point of view. Speaker 200:14:25Thank you, Kristian. So we have a broad R and D pipeline of AI immunology design cancer vaccine candidates spanning two major disease areas, cancer and infectious diseases. Today, I'll walk you through some of our most important programs where we've made significant recent progress. So I'll begin with our lead acid, EVX-one. This is our personalized peptide based cancer vaccine currently in phase two clinical development, as Kristen just mentioned. Speaker 200:15:01Then I'll touch on the advancement in our precision cancer vaccine program targeting this novel class of tumor antigens that we have seen are shared across patients. And then I will give a update on our two bacterial vaccine programs, EDXB2 and B3, which are part of the licensing and option agreements that we have with NSD, as Christian mentioned earlier. And finally, I will give a brief update on our cytomegalovirus or CNV vaccine program. So EVX-one, as mentioned, is currently in phase two and is being developed as a first line treatment for advanced melanoma. And EVX-one includes multiple patient specific neoantigens that we have identified with our AI immunology platform based on the patient's unique tumor mutational profile. Speaker 200:15:59And we administered EVX-one in combination with the checkpoint inhibitor, anti PD-one from MST, with a goal of enhancing clinical efficacy. So as Christian mentioned, we shared a one year interim data at the ESMO Congress in September, and we reported an overall response rate of sixty nine comparing favorably to historical pembrolizumab monotherapy data. And further, we showed that seventy nine percent of the EVX-one vaccine neoantigens induced a specific immune response in the patients, confirming the precision and predictive power of our AI immunology platform. And building on this positive data and to further explore response and also the clinical response, we have, as Kristin mentioned, extended the phase two trials one additional year to allow us to collect three year outcome data. And notably, during this extension phase, EVX-one will be administered as a monotherapy, allowing us to better understand the vaccine's standalone effect. Speaker 200:17:20And as Kristen also mentioned, this extension involves minimal additional costs as the clinical trials are already up and running, and the vaccines are actually ready to to be used. We are looking forward to sharing further updates on this program first at the upcoming AACR annual meeting later this month and then to present two year efficacy data in the second half of 'twenty five. So let's turn our focus to our promising precision cancer vaccine concept. In this program, we're using AI immunology to design a precision vaccine targeting these nonconventional antigens, so called ERV tumor antigens, that are shared across patients. And at the ESMO Immuno Oncology Congress in December, we presented pre preclinical proof of concept data demonstrating that our vaccine concept induced a strong antigen specific T cell responses in both humanized mice and in human immune cells, and further that we could inhibit the tumor growth in preclinical models. Speaker 200:18:47And as Kristen also alluded to, we believe that this precision approach could allow for a broader applicability of these cancer vaccines also for patients that are less likely to respond to conventional cancer immunotherapies. And with this very promising data in hand, are on track for selecting the lead candidate in the second half of twenty twenty five. So our collaboration with MSC continues to progress as planned. In 2023, we entered into a target discovery collaboration focusing on a bacterial pathogen causing severe medical issues and where there is no existing vaccines approved. And in 2024, this collaboration was significantly expanded to include an option and license agreement for our proprietary EDXB2 gonorrhea vaccine candidate. Speaker 200:19:53And we received an upfront payment of 3,200,000.0 US dollars with a potential 10,000,000 upon option exercise and further up to $592,000,000 per product in milestone payments. So both EVXB2 and C3 are advancing steadily, and we remain on track for a potential option exercise in the second half of twenty five. So we also made strong progress in our cytomegalovirus vaccine program. And CMV is a widespread viral pathogen with high global seroprevalence. It causes severe complications, especially in immunocompromised patients, and also congenital infections can lead to severe birth defects, and yet no approved vaccines currently exist. Speaker 200:20:54And with AI immunology, we have identified novel B and C cell targets which can complement known antigens such as glycoprotein B. And this program was initially launched in partnership with Xpression Biotechnologies, as Christine mentioned, and we now have acquired full rights positioning us to drive the program forward independently. So with these very positive data, we are on track for vaccine antigen selection in the second half of twenty twenty five. So just to wrap up, we've seen significant progress across our pipeline in both oncology and infectious diseases, and we are extremely excited about what lies ahead and are looking forward to updating you on our programs as they continue to advance. Speaker 100:21:52Thank you, Birgitte. I think we can only all agree that it has been a truly exciting year across both cancer and infectious diseases, and that surely makes for an exciting 2025 as well. But let's look a little bit more at the past year and zoom in on the numbers. So, Thomas, will you take us through the financials, please? Speaker 300:22:17Yes. Thank you, Christian and begin. If we move to the financial and the financial highlights to start with, for 2024, we have recorded revenue of $3,300,000 coming from the options optional license agreement with MSD, which Christian mentioned earlier. This certainly also may generate income for the future. As Begida also says, we are on track to the next towards the next milestone payment in the second half of this year, plus, of course, then hopefully in the years beyond. Speaker 300:23:04In 2024, we've also seen lower spend compared to the previous year, and this has very much been driven by the full year impact from the changes that we made back in 02/2023 and certainly also ongoing cost optimization and further initiatives in order to manage our cost and cash burn. We are certainly trying to make the best use of the cash that we have at hand. And December 2024, cash and cash equivalents were at $6,000,000, which is slightly up from $5,600,000 end of 20 20 3, but, of course, then also having made the effort of investing into our pipeline and platform. We've seen significant improvements in our equity and the financial position through also the recent capital market activities. And with now our existing cash position, we estimate that we have sufficient funds to fund our operating and capital expenditure requirement into mid-twenty twenty six. Speaker 300:24:29And important to note is that that takes us beyond the point of a potential option exercised by MSD and also beyond our two year clinical data readout on EVX o one. If we look at the profit and loss statement of 2024, we have had a net loss for the year of $10,600,000. That's corresponding to 20¢ per basic and diluted shares share, which is also a slight or or improvement, so to speak, still a loss, of course, but versus 2023 where we had a loss of $22,000,000. Again, the the loss was really driven by improvement in our recognized revenue, but certainly also, as mentioned, the reduction in our r and d and g and a expenses. Most of that came certainly from a reduced headcount, but we've also made changes throughout the entire organization, including management, and the full year impact of that plus, as mentioned, the general cost optimization is ongoing and has really played through throughout the entire 2024. Speaker 300:25:54Looking a little bit ahead for 2025, Christian also mentioned that we expect that our operational cash burn is on par with 2024, meaning, again, also around $14,000,000 for the year, and that is despite that we will increase our activity level throughout the pipeline and platform element. Balance sheet. We have certainly improved the equity throughout 2024, as mentioned, and continuing to invest in our pipeline and platform. And also, in the beginning of this year, we have further have successful equity improvement. So cash and cash equivalent as January 27 were $11,900,000. Speaker 300:26:54And our public offering, which flows on January 31, we could add a gross proceeds of 10,800,000.0 to towards our cash and cash position. With that also, we are well above the NASDAQ minimum requirement on equity and shareholders' equity, which also, again, as Christian mentioned before, also we managed, therefore, really to be back in full compliance with the NASDAQ requirement, not only in now in q one, but expect to be that also for the remaining part of 2025. Cash runway will take us to mid-twenty twenty six, as already stated. And again, just to do that once again, that will further extend with a potential MSD option exercise should that happen. And assuming that exercise will happen in the second half of twenty five, we will have a cash position well into 2027. Speaker 300:28:08And with that update on the financials, I hand it over to you, Christian. Speaker 100:28:13Excellent. Thank you so much, Thomas. And, also thanks again to you, Brigitte. Let me just, provide a few, conclusive remarks. If we look at the overall picture, I would say Evaxin has has never been in stronger position fundamentally. Speaker 100:28:34We have been delivering strongly on our pipeline both from a cancer and infectious disease point of view. We are in the fortunate situation that the EBX-one continues to deliver very strong clinical data, and we have a lot of activities within the infectious disease area where there are significant unmet needs, given many of the indications that we are targeting don't have any approved vaccines today. So, combining that with a transformative agreement with MSD, MSD as a significant shareholder and a solid cash position, we are in a very strong position fundamentally, which provides a solid basis for 2025. And I would say here that we are well positioned for for strong '25 execution. We have our milestones, our value triggers, and our priorities locked in, and then the full organization is around that. Speaker 100:29:41And we are well on our way towards executing upon our 2025 priorities. This all comes from having a clear strategy with with a strong focus on on monetizing value through business development via both the platform and and the pipeline. And that, of course, also leads to several key value catalysts coming up in 2025. We are talking about the potential option exercise from MSC, EVX-one phase two data, and, of course, a number of other important milestones coming up throughout the year. So I think I speak on behalf of the whole management team and the whole organization, but I can say that we are very pleased with where we are and definitely looking very much forward to 2025. Speaker 100:30:30And with that, we will open for q and a and take any questions you you might have. Operator00:30:39Thank you, sir. As a reminder, to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. You. We are now going to proceed with our first question. Operator00:31:08And the questions come from the line of Thomas Furtin from Lake Street Capital Markets. Speaker 400:31:19Christian, I was just wondering, as you select new pipeline candidates, you've got two infectious disease and an ERV candidate that you're going to select this year. How are you certain that those will be partnerable assets? Are these being done with input from potential partners? Is it based on literature? I'm just curious if you can take us through that decision making process a little bit. Speaker 100:31:38Yeah. No. Thanks, Thomas. I think that's a super super relevant question, of course, because it it is about creating partnerable assets, especially when you have a a multi partner approach, then you need to make sure that what you are developing is also what what people want. Of course, it all starts with, you can say, the unmet medical need and the commercial potential. Speaker 100:32:04That's kind of like the first gate that you can, of course, find many areas where there's either not a whole lot of unmet need or the commercial potential is not sufficient. So that's the number one priority. And then we do actually and that's what we are planning for both, say, the ERF based concept, but also some of the infectious disease candidates we are working on, aiming at taking early dialogues with potential partners saying this is what we intend to do from a preclinical package point of view. Are there any other things you would see? Not because we want to engage necessarily in partnering discussions now, but solicit the input from future potential partners. Speaker 100:32:56And I do believe that it's very important that we get these input early so so the preclinical program can be shaped in in in the right way. Of course, we we have a lot of things we would like to do, but we also need to make sure that we have the packets that that potential partners are asking for. Birgit, I don't know if you wanna say a few more words on this, but but this early consultation is definitely something that we have will have focus on for for, you can say, the HER program, for some of our infectious disease programs, especially when you are in areas where which are novel and you're breaking new ground, then it's critical to understand what would a potential buyer want to see as early as possible. Speaker 200:33:50Yeah. Especially for the two new infectious disease vaccine candidates that we will nominate this year. I mean, that's that's, of course, the option that you also alluded to, Thomas, that it could be coming from partner discussions. But we also have done a lot of work on looking into different options. We have a long list of potential diseases to target, and we've done, as you call it, literature analysis, dry analysis, looking into the medical needs, the commercial potential, and and feasibility. Speaker 200:34:24And we are definitely ready to to launch a new program in in this first half of twenty twenty three. Speaker 400:34:35Excellent. That's super helpful. And with respect to Expression Biotech, handing the rights back to the CMV, vaccine, can you give us some some color behind that? Was it a was it a decision on their end? Was it a joint decision? Speaker 400:34:48Is there any capability that you're losing in the development of the program with them no longer being partner? Speaker 100:34:54Let me first answer the overall I mean, the decision was at their end. The way the program is structured is that, either party could terminate, then the rights would go fully back to the other party. So you can say we have not had the cash up or anything, but have have, as per contract, acquired acquired the full rights, which we are very pleased with. And then to the capabilities, Peter, you can you can speak to that. But I think we have a definitely a good plan in place, and and are looking forward to drive this forward our on on our own. Speaker 200:35:34Yeah. So so Expressions Biotechnology, they were doing some of the the production part of the antigen. And, of course, we're looking into other solutions for getting the antigens into our lab and to test them. And we have also experienced that when we have partner dialogues, it's not always the right approach to come with a very defined modality. Partners often tend to have their own preferences, and therefore, we would also need to test our AI immunology identified targets on on a few different vaccine modalities. Speaker 200:36:15So that's the ongoing work currently. And then we are, of course, preparing for the selection of the the vaccine antigens in the second half of twenty twenty five. Speaker 100:36:28So you can say we are we, of course, have truly enjoyed the collaboration with Expression Biotech over the past couple of years and have been very pleased with that. Then, I think this also gives us quite a unique opportunity for deploying some of the learnings that we have had over the past couple of years in in many of the partnering discussions that we have had as to having some degree of flexibility in how how you pack or wrap the the final vaccine candidate. So I think we we we have, as I said, we have a good plan in place and and are looking forward to to selecting lead antigens in the in the second half of the year. Speaker 400:37:10Great. Thank you for taking my questions. I appreciate it. Operator00:37:16Thank you. We are now going to proceed with our next question. And the questions come from the line of Swayampakula Ramakanth Please ask your question. Speaker 500:37:42Thank you. Good afternoon, Christian and Brigitte. Hey, Swayampakula Couple of hi. Couple of quick questions. The first one being on EBX zero one. Speaker 500:37:56So in terms of the data coming out, at AACR, what what what what sort of data should we be expecting? And then more importantly, as we wait for this for this, two year data point, coming up later in the year, based on your conversations with potential collaborators to date, you know, what what amount of data do you think eventually is sufficient for a transaction? Because this is a program that's been, that I think has produced pretty good set of data. So so what else are are people really looking for? Speaker 200:38:43I can start. So for the presentation at AACR, we will be presenting biomarker data and also additional T cell data from the patient. And we have already shared some of these earlier data, and we have now collected more samples and analyzed more samples from the patients. So it will be a more in-depth biomarker presentation at AACR. Speaker 100:39:14And then for the, you can say, data, what's needed? I I do think that the data that we are currently generating, and and also will be generating over the the remainder of the trial, that that is the data that we need. What is also then important for, for, you can say, a eventual transaction, that's definitely also there's a lot of, people waiting to see what are the data Merck and Moderna is gonna generate going to look like. And, of course, here, we we were pretty encouraged seeing that Moderna was out of the TG Carbon Conference earlier this year saying that they are anticipating approval in 2027, hence, continued good progress with their personalized cancer vaccine. And I would not expect that one would need to wait until approval, but we it will be interesting to see some of the early phase three data from from that trial. Speaker 100:40:24That that's clear that people are also awaiting awaiting that. So I I would say we have what what I feel is needed from an EVXO one one point of view, and then there's some level of comfort confirmation that those data would also hold up in a in a larger scale later stage phase three trial, which we hopefully will see later on this year. Perfect. Speaker 500:40:55And then regarding the ERV vaccines that that you plan to work on, what types of cancers could potentially be be be the indications that we could use these vaccines to evaluate? Speaker 200:41:17Yeah. Really good question. Okay. So we have worked with the ERV concept for quite some time now. We have looked into a lot of data from different cancer indications and have mapped out the indications where there is a high burden as recorded. Speaker 200:41:36And that has led to the development of this precision herb vaccine concept where we can see that in specific indications that these sequences are shared across the patients. And we have a list of of these cancer indications that we would like to work more on, and we will most likely also share some more information by the by the end of this year on on the possible indications to to move forward with. Speaker 500:42:13Okay. And then the last question from me, you know, regarding EVX b two and b three, you know, would would you be releasing any data ahead of, submitting, to MSD or as you're submitting to MSD for their decision, on exercising the option? Speaker 100:42:39No. You can say for for b two, MSD is, doing some confirmatory work on the data that we have generated. Hence, we will not be be releasing more data there. B three, that's the finalization of of the current of the work plan that we agreed in 2023 that that's being completed. And the major part of work there is with with MSD as well. Speaker 500:43:12Okay. Perfect. Thank you both. Thanks for taking all my questions. Speaker 100:43:16You're welcome. Good talking to Operator00:43:21As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Thank you. We have no further questions at the moment registered. So I will now hand back to Christian Kansrup for closing remarks. Speaker 100:43:49Thank you so much. And I just want to wrap up by saying thank you to all of you for listening in, and thank you for the questions as well. As already said, 2024 was a very exciting year, creating a strong foundation for 2025. We are now in execution mode and will be focusing on delivering on our key milestones for the year. So we are definitely looking very much forward to to 2025, and we'll, of course, make sure to keep you all up to date on all recent events, the of action. Speaker 100:44:29So once again, thank you so much for taking the time for listening in, and we will stay in touch. Operator00:44:36This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a good day.Read morePowered by Conference Call Audio Live Call not available Earnings Conference CallEvaxion Biotech A/S Q4 202400:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(6-K)Annual report(20-F) Evaxion Biotech A/S Earnings HeadlinesEvaxion Biotech: Evaxion to present at World Vaccine CongressApril 10, 2025 | finanznachrichten.deEvaxion to present at World Vaccine CongressApril 10, 2025 | globenewswire.comTrump to unlock 15-figure fortune for America (May 3rd) ?We were shown this map by former Presidential Advisor, Jim Rickards, one of the most politically connected men in America. Rickards has spent his fifty-year career in the innermost circles of the U.S. government and banking. And he believes Trump could soon release this frozen asset to the public. April 19, 2025 | Paradigm Press (Ad)Evaxion Biotech A/S (NASDAQ:EVAX) Q4 2024 Earnings Call TranscriptApril 4, 2025 | msn.comEarnings call transcript: Evaxion Biotech Q4 2024 sees improved financialsApril 3, 2025 | uk.investing.comEvaxion Biotech’s Optimistic Earnings Call HighlightsApril 2, 2025 | tipranks.comSee More Evaxion Biotech A/S Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Evaxion Biotech A/S? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Evaxion Biotech A/S and other key companies, straight to your email. Email Address About Evaxion Biotech A/SEvaxion Biotech A/S (NASDAQ:EVAX), a clinical-stage biotech company, engages in developing artificial intelligence-powered immunotherapies. The company develops EVX-01, which is in phase 2 global multi-center clinical trial for the treatment of metastatic melanoma; EVX-02, a DNA-based vaccine that is in Phase 1/2a trial designed to induce a therapeutic immune response in the adjuvant setting in patients with resected melanoma; and EVX-03, DNA-based cancer vaccine for the treatment of various cancers. Its programs also include some vaccines that are in pre-clinical stage, which includes EVX-B1 for the prevention of S. aureus-induced skin and soft tissue infections in patients undergoing elective abdominal hernia surgery; EVX-B2 to target diseases caused by N. gonorrhoeae; EVX-B3 for eliciting strong humoral antibody and cellular immune response to the bacterial pathogen; and EVX-V1, viral vaccine product candidate for targeting Cytomegalovirus. Evaxion Biotech A/S was incorporated in 2008 and is based in Horsholm, Denmark.View Evaxion Biotech A/S ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Archer Aviation Unveils NYC Network Ahead of Key Earnings Report3 Reasons to Like the Look of Amazon Ahead of EarningsTesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? 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There are 6 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Evaxion Biotech Business Update Full Year twenty twenty four Conference Call and Webcast. At this time, all participants will be in listen only mode. After the speakers' presentation, there will be a question and answer session. Please note that today's conference is being recorded. Operator00:00:33I would now like to hand the conference over to your speaker, Christian Kangstropp, CEO. Please go ahead. Speaker 100:00:40Thank you so much, and good morning, and good afternoon to all of you, and a very warm welcome to this Evaxion full year twenty twenty four business update call. I'm Christian Kansrup, CEO of Evaxion. With me today, I have Birgitte Roijnu, our chief science officer Thomas Smith, our chief financial officer and Mads Kronborg, our VP of Investor Relations and Communications. And I think it's fair to say that 2024 was a super exciting year for Evaxion with lots of achievements throughout the year, and we are looking very much forward to be giving you an update on the year. And the agenda and what we intend to cover. Speaker 100:01:28First of all, I will start out recapping on 2024, looking ahead into 2025 and some of the significant milestones that we see in front of us. Birgitte will be taking us through the R and D update. Thomas will cover the 2024 financial results. And I will be having a few concluding remarks before we, as usual, jump into the Q and A. And another thing that is, as usual, is the forward looking statements. Speaker 100:02:01We will be talking about the future. And of course, talking about the future entails uncertainties. Hence, I direct your attention to the forward looking statements slide on Slide number three. And with that, let's get into the agenda and start out with recapping on '24 and looking ahead. First of all, as I already said, I think it's fair to say 2024 was a year of substantial progress across Evaction. Speaker 100:02:31That goes for all parts of the business if we look at business development, if we look at R and D, if we look at our platform and also when we look at financing. I'm truly proud of what the team and the whole organization has achieved throughout the year. I think it's also fair to say that it has provided us with a very strong foundation going into 2025. But if we start out looking at business development here, of course, we entered into the transformational partnership with MSD in September 2024, a very important achievement for the year. And I'm also happy to say that we are tracking well towards potential option exercise in the second half of twenty twenty five. Speaker 100:03:19Begither will also be getting back to this. Also, I'm pleased to say that our current business development pipeline supports our ambition of at least two new agreements. Just to recap, we have a very strong focus on partnering as a way of realizing value of both our platform and pipeline. And of course, maintaining a business development pipeline, which can generate future partnerships is important to us. From an R and D point of view, we have continued the successful execution of the ongoing EVX-one Phase two trial. Speaker 100:03:55We presented convincing one year data in the fall of last year, '60 '9 percent overall response rate at the one year readout of the ongoing Phase II trial, and fifteen out of sixteen patients showing a reduction in tumor target lesions. Truly exciting data, which makes us look very much forward to the two year readout that we will be having in the second half of the year. What we have also done is established a completely new precision cancer vaccine concept deploying our AI immunology platform targeting nonconventional endogenous retroviruses, tumor antigens which are shared across patients. This is exciting because it broadens the potential of cancer vaccines. And a precision based approach is a very nice complement to our personalized cancer vaccine EVX-one, which has complemented it nicely. Speaker 100:04:57Looking at the platform, AI immunology, it's a core of our business. And of course, ensuring ongoing development and performance improvement of the platform is critical for staying off the forefront of AI derived development of novel medicines. And here I'm very pleased that we last year launched a novel toxin antigen predictor, which allows us for developing even better bacterial vaccines. This continuous improvement of both capabilities and the performance of AI immunology remains a priority to us. Last but not least, financing is, of course, an important factor in our business. Speaker 100:05:45And here, I'm pleased to say that we, by public offering and other capital market activities, have extended our cash at hand to mid-twenty twenty six. In addition to that, Merck or MSD Global Health Innovation Fund have invested in us for the third time, now holding a close to 20% equity stake. We are very pleased about the strong relationship we have with the Merck or MSD Global Health Innovation Fund and are pleased to see the continued and ongoing support and, of course, welcome them as a significant shareholder in Evaxion. If we then turn to the next slide and look ahead, we have quite significant value triggers coming up throughout the year. I'm also pleased to say that we already delivered on our first milestone for the year, which is the all patients completing dosing in the EBX-one trial. Speaker 100:06:43What we also will be presenting later on this month, actually, at the AACR meeting is additional EBX-one data. Looking into the second half, a number of significant milestones here. The MSD Maxine collaboration and the decision on option exercise is expected in the second half, could generate up to $10,000,000 in income to Evaction if MSD exercises the options to both. Needless to say, a very important milestone for us. And also, as I already mentioned, pleased to see that collaboration is on track. Speaker 100:07:24Then we will have the two year readout on EVX-one in the second half of the year as well. With a strong one year readout, we are very much looking forward to that. We will be selecting lead antigens for our CMV vaccine candidate, which now is a fully owned candidate, which we also are looking forward to. And then building on the Precision vaccine concept comments I had just before, we will be selecting lead vaccine candidate in the second half as well. Throughout the year, two other significant milestones: business development. Speaker 100:08:06We have the ambition of generating at least two new agreements in 2025 and are working hard towards that. And continuing building our pipeline is also a priority with a multi partner approach, partnering around existing pipeline candidates just as we included the EVXB2 in the collaboration with MSD, then we need to continue to build the pipeline with novel candidates in order to ensure that we have an attractive and broad pipeline of novel vaccine candidates, which we can partner via our multi partner approach. Here, we have the target of two new pipeline candidates within infectious diseases, one in the first half and one in the second half. Also here, pleased to say that we are well on track towards meeting that. Just a very quick recap on our focus. Speaker 100:09:06Our focus is on deriving value from both our platform and our pipeline. And the unique nature here is the complementarity of having a dual focus on platform and pipeline, which is driven by the unique capabilities and properties of AI immunology and the multidisciplinary capabilities that we have built around our AI immunology platform. Focus of the platform, that is, to enter into high value, low risk partnerships around target discovery, design, and development of novel vaccine candidates. The MSD collaboration around EVHXB3 is a good example of that. And then it's, of course, also deploying the platform to expand and build our own pipeline, just as we have the target of these two new infectious disease candidates for the year. Speaker 100:10:01Pipeline, that is around advancing select high value programs into preclinical and early clinical development, leveraging our multidisciplinary capability base, and then pursue partnering at the right point in time. The partnering with MSC around EVX-two is a good example of what we want to do here. And of course, we have EBX-one in phase two development and very much looking forward to the clinical data readout later on this year. So focusing on both platform and pipeline, but being able to do so in a cost effective way via the unique features of the AI immunology platform and the multidisciplinary capabilities we have around that. We are confident that this strategy will generate significant opportunities going forward and are executing in full focus on that. Speaker 100:11:00And then before handing over to Birgitte, I would just touch a little bit on a few recent events. In January, we completed a public offering. And together with other capital market activities, we have raised $17,000,000 this year, extending our cash runway to mid-twenty twenty six. As already mentioned, MSD, Global Health Innovation Fund participated in the offering. But what I'm also very pleased around is to see other healthcare focused investors in the public offering. Speaker 100:11:34With that offering, we have had a very nice expansion of our investor base and looking forward to continuing the collaboration with those investors we got in in that round. We have also communicated that we are in agreement and discussions with the European Investment Bank around conversion of €3,500,000 out of the €7,000,000 loan we have with ERP into an equity type instrument. Originally, we had communicated we expected that completed in the first quarter. We can see that some of the legal documentations takes longer to complete than anticipated, but now we are expecting to complete this in the second quarter. This will enable a significant simplification of our balance sheet and also save cost in terms of interest payments going forward. Speaker 100:12:28So we are looking forward to having that loan conversion converted into equity. We, in 2024, got a delisting determination from NASDAQ. We are very pleased to say that has been withdrawn here in the first quarter. We are now in full compliance with all NASDAQ listing requirements. Another thing that makes me proud and happy is the ongoing efforts in the whole organization in terms of optimizing our spend. Speaker 100:12:58And that has enabled us to have a 2025 operational cash burn at US14 million dollars which is the same level as 2024 despite an increased activity level. And this ongoing spend optimization is, of course, important because it allows us to do more while still being very cautious in how we spend our cash. Finally, also for the first quarter, EVX-one completed dosing. I already mentioned that. What we also have announced is that we have extended the EVX-one trial from two to three years. Speaker 100:13:37Important, this is not because we haven't seen good data or the data we expected. On the contrary, it's because we have seen very good data. And, we had the opportunity in a very cost effective way, given patients are in the trial, given we had EVX-one already produced, to extend the trial with one year at minimal cost. And this allows us to generate three year data on this truly novel personalized cancer vaccine, which will create for a very strong data package. So excited about that opportunity of expanding the trial, and Birgitte will also be getting back to that. Speaker 100:14:17And with that, Birgitte, I will hand over to you to give an update from an R and D point of view. Speaker 200:14:25Thank you, Kristian. So we have a broad R and D pipeline of AI immunology design cancer vaccine candidates spanning two major disease areas, cancer and infectious diseases. Today, I'll walk you through some of our most important programs where we've made significant recent progress. So I'll begin with our lead acid, EVX-one. This is our personalized peptide based cancer vaccine currently in phase two clinical development, as Kristen just mentioned. Speaker 200:15:01Then I'll touch on the advancement in our precision cancer vaccine program targeting this novel class of tumor antigens that we have seen are shared across patients. And then I will give a update on our two bacterial vaccine programs, EDXB2 and B3, which are part of the licensing and option agreements that we have with NSD, as Christian mentioned earlier. And finally, I will give a brief update on our cytomegalovirus or CNV vaccine program. So EVX-one, as mentioned, is currently in phase two and is being developed as a first line treatment for advanced melanoma. And EVX-one includes multiple patient specific neoantigens that we have identified with our AI immunology platform based on the patient's unique tumor mutational profile. Speaker 200:15:59And we administered EVX-one in combination with the checkpoint inhibitor, anti PD-one from MST, with a goal of enhancing clinical efficacy. So as Christian mentioned, we shared a one year interim data at the ESMO Congress in September, and we reported an overall response rate of sixty nine comparing favorably to historical pembrolizumab monotherapy data. And further, we showed that seventy nine percent of the EVX-one vaccine neoantigens induced a specific immune response in the patients, confirming the precision and predictive power of our AI immunology platform. And building on this positive data and to further explore response and also the clinical response, we have, as Kristin mentioned, extended the phase two trials one additional year to allow us to collect three year outcome data. And notably, during this extension phase, EVX-one will be administered as a monotherapy, allowing us to better understand the vaccine's standalone effect. Speaker 200:17:20And as Kristen also mentioned, this extension involves minimal additional costs as the clinical trials are already up and running, and the vaccines are actually ready to to be used. We are looking forward to sharing further updates on this program first at the upcoming AACR annual meeting later this month and then to present two year efficacy data in the second half of 'twenty five. So let's turn our focus to our promising precision cancer vaccine concept. In this program, we're using AI immunology to design a precision vaccine targeting these nonconventional antigens, so called ERV tumor antigens, that are shared across patients. And at the ESMO Immuno Oncology Congress in December, we presented pre preclinical proof of concept data demonstrating that our vaccine concept induced a strong antigen specific T cell responses in both humanized mice and in human immune cells, and further that we could inhibit the tumor growth in preclinical models. Speaker 200:18:47And as Kristen also alluded to, we believe that this precision approach could allow for a broader applicability of these cancer vaccines also for patients that are less likely to respond to conventional cancer immunotherapies. And with this very promising data in hand, are on track for selecting the lead candidate in the second half of twenty twenty five. So our collaboration with MSC continues to progress as planned. In 2023, we entered into a target discovery collaboration focusing on a bacterial pathogen causing severe medical issues and where there is no existing vaccines approved. And in 2024, this collaboration was significantly expanded to include an option and license agreement for our proprietary EDXB2 gonorrhea vaccine candidate. Speaker 200:19:53And we received an upfront payment of 3,200,000.0 US dollars with a potential 10,000,000 upon option exercise and further up to $592,000,000 per product in milestone payments. So both EVXB2 and C3 are advancing steadily, and we remain on track for a potential option exercise in the second half of twenty five. So we also made strong progress in our cytomegalovirus vaccine program. And CMV is a widespread viral pathogen with high global seroprevalence. It causes severe complications, especially in immunocompromised patients, and also congenital infections can lead to severe birth defects, and yet no approved vaccines currently exist. Speaker 200:20:54And with AI immunology, we have identified novel B and C cell targets which can complement known antigens such as glycoprotein B. And this program was initially launched in partnership with Xpression Biotechnologies, as Christine mentioned, and we now have acquired full rights positioning us to drive the program forward independently. So with these very positive data, we are on track for vaccine antigen selection in the second half of twenty twenty five. So just to wrap up, we've seen significant progress across our pipeline in both oncology and infectious diseases, and we are extremely excited about what lies ahead and are looking forward to updating you on our programs as they continue to advance. Speaker 100:21:52Thank you, Birgitte. I think we can only all agree that it has been a truly exciting year across both cancer and infectious diseases, and that surely makes for an exciting 2025 as well. But let's look a little bit more at the past year and zoom in on the numbers. So, Thomas, will you take us through the financials, please? Speaker 300:22:17Yes. Thank you, Christian and begin. If we move to the financial and the financial highlights to start with, for 2024, we have recorded revenue of $3,300,000 coming from the options optional license agreement with MSD, which Christian mentioned earlier. This certainly also may generate income for the future. As Begida also says, we are on track to the next towards the next milestone payment in the second half of this year, plus, of course, then hopefully in the years beyond. Speaker 300:23:04In 2024, we've also seen lower spend compared to the previous year, and this has very much been driven by the full year impact from the changes that we made back in 02/2023 and certainly also ongoing cost optimization and further initiatives in order to manage our cost and cash burn. We are certainly trying to make the best use of the cash that we have at hand. And December 2024, cash and cash equivalents were at $6,000,000, which is slightly up from $5,600,000 end of 20 20 3, but, of course, then also having made the effort of investing into our pipeline and platform. We've seen significant improvements in our equity and the financial position through also the recent capital market activities. And with now our existing cash position, we estimate that we have sufficient funds to fund our operating and capital expenditure requirement into mid-twenty twenty six. Speaker 300:24:29And important to note is that that takes us beyond the point of a potential option exercised by MSD and also beyond our two year clinical data readout on EVX o one. If we look at the profit and loss statement of 2024, we have had a net loss for the year of $10,600,000. That's corresponding to 20¢ per basic and diluted shares share, which is also a slight or or improvement, so to speak, still a loss, of course, but versus 2023 where we had a loss of $22,000,000. Again, the the loss was really driven by improvement in our recognized revenue, but certainly also, as mentioned, the reduction in our r and d and g and a expenses. Most of that came certainly from a reduced headcount, but we've also made changes throughout the entire organization, including management, and the full year impact of that plus, as mentioned, the general cost optimization is ongoing and has really played through throughout the entire 2024. Speaker 300:25:54Looking a little bit ahead for 2025, Christian also mentioned that we expect that our operational cash burn is on par with 2024, meaning, again, also around $14,000,000 for the year, and that is despite that we will increase our activity level throughout the pipeline and platform element. Balance sheet. We have certainly improved the equity throughout 2024, as mentioned, and continuing to invest in our pipeline and platform. And also, in the beginning of this year, we have further have successful equity improvement. So cash and cash equivalent as January 27 were $11,900,000. Speaker 300:26:54And our public offering, which flows on January 31, we could add a gross proceeds of 10,800,000.0 to towards our cash and cash position. With that also, we are well above the NASDAQ minimum requirement on equity and shareholders' equity, which also, again, as Christian mentioned before, also we managed, therefore, really to be back in full compliance with the NASDAQ requirement, not only in now in q one, but expect to be that also for the remaining part of 2025. Cash runway will take us to mid-twenty twenty six, as already stated. And again, just to do that once again, that will further extend with a potential MSD option exercise should that happen. And assuming that exercise will happen in the second half of twenty five, we will have a cash position well into 2027. Speaker 300:28:08And with that update on the financials, I hand it over to you, Christian. Speaker 100:28:13Excellent. Thank you so much, Thomas. And, also thanks again to you, Brigitte. Let me just, provide a few, conclusive remarks. If we look at the overall picture, I would say Evaxin has has never been in stronger position fundamentally. Speaker 100:28:34We have been delivering strongly on our pipeline both from a cancer and infectious disease point of view. We are in the fortunate situation that the EBX-one continues to deliver very strong clinical data, and we have a lot of activities within the infectious disease area where there are significant unmet needs, given many of the indications that we are targeting don't have any approved vaccines today. So, combining that with a transformative agreement with MSD, MSD as a significant shareholder and a solid cash position, we are in a very strong position fundamentally, which provides a solid basis for 2025. And I would say here that we are well positioned for for strong '25 execution. We have our milestones, our value triggers, and our priorities locked in, and then the full organization is around that. Speaker 100:29:41And we are well on our way towards executing upon our 2025 priorities. This all comes from having a clear strategy with with a strong focus on on monetizing value through business development via both the platform and and the pipeline. And that, of course, also leads to several key value catalysts coming up in 2025. We are talking about the potential option exercise from MSC, EVX-one phase two data, and, of course, a number of other important milestones coming up throughout the year. So I think I speak on behalf of the whole management team and the whole organization, but I can say that we are very pleased with where we are and definitely looking very much forward to 2025. Speaker 100:30:30And with that, we will open for q and a and take any questions you you might have. Operator00:30:39Thank you, sir. As a reminder, to ask a question, please press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. You. We are now going to proceed with our first question. Operator00:31:08And the questions come from the line of Thomas Furtin from Lake Street Capital Markets. Speaker 400:31:19Christian, I was just wondering, as you select new pipeline candidates, you've got two infectious disease and an ERV candidate that you're going to select this year. How are you certain that those will be partnerable assets? Are these being done with input from potential partners? Is it based on literature? I'm just curious if you can take us through that decision making process a little bit. Speaker 100:31:38Yeah. No. Thanks, Thomas. I think that's a super super relevant question, of course, because it it is about creating partnerable assets, especially when you have a a multi partner approach, then you need to make sure that what you are developing is also what what people want. Of course, it all starts with, you can say, the unmet medical need and the commercial potential. Speaker 100:32:04That's kind of like the first gate that you can, of course, find many areas where there's either not a whole lot of unmet need or the commercial potential is not sufficient. So that's the number one priority. And then we do actually and that's what we are planning for both, say, the ERF based concept, but also some of the infectious disease candidates we are working on, aiming at taking early dialogues with potential partners saying this is what we intend to do from a preclinical package point of view. Are there any other things you would see? Not because we want to engage necessarily in partnering discussions now, but solicit the input from future potential partners. Speaker 100:32:56And I do believe that it's very important that we get these input early so so the preclinical program can be shaped in in in the right way. Of course, we we have a lot of things we would like to do, but we also need to make sure that we have the packets that that potential partners are asking for. Birgit, I don't know if you wanna say a few more words on this, but but this early consultation is definitely something that we have will have focus on for for, you can say, the HER program, for some of our infectious disease programs, especially when you are in areas where which are novel and you're breaking new ground, then it's critical to understand what would a potential buyer want to see as early as possible. Speaker 200:33:50Yeah. Especially for the two new infectious disease vaccine candidates that we will nominate this year. I mean, that's that's, of course, the option that you also alluded to, Thomas, that it could be coming from partner discussions. But we also have done a lot of work on looking into different options. We have a long list of potential diseases to target, and we've done, as you call it, literature analysis, dry analysis, looking into the medical needs, the commercial potential, and and feasibility. Speaker 200:34:24And we are definitely ready to to launch a new program in in this first half of twenty twenty three. Speaker 400:34:35Excellent. That's super helpful. And with respect to Expression Biotech, handing the rights back to the CMV, vaccine, can you give us some some color behind that? Was it a was it a decision on their end? Was it a joint decision? Speaker 400:34:48Is there any capability that you're losing in the development of the program with them no longer being partner? Speaker 100:34:54Let me first answer the overall I mean, the decision was at their end. The way the program is structured is that, either party could terminate, then the rights would go fully back to the other party. So you can say we have not had the cash up or anything, but have have, as per contract, acquired acquired the full rights, which we are very pleased with. And then to the capabilities, Peter, you can you can speak to that. But I think we have a definitely a good plan in place, and and are looking forward to drive this forward our on on our own. Speaker 200:35:34Yeah. So so Expressions Biotechnology, they were doing some of the the production part of the antigen. And, of course, we're looking into other solutions for getting the antigens into our lab and to test them. And we have also experienced that when we have partner dialogues, it's not always the right approach to come with a very defined modality. Partners often tend to have their own preferences, and therefore, we would also need to test our AI immunology identified targets on on a few different vaccine modalities. Speaker 200:36:15So that's the ongoing work currently. And then we are, of course, preparing for the selection of the the vaccine antigens in the second half of twenty twenty five. Speaker 100:36:28So you can say we are we, of course, have truly enjoyed the collaboration with Expression Biotech over the past couple of years and have been very pleased with that. Then, I think this also gives us quite a unique opportunity for deploying some of the learnings that we have had over the past couple of years in in many of the partnering discussions that we have had as to having some degree of flexibility in how how you pack or wrap the the final vaccine candidate. So I think we we we have, as I said, we have a good plan in place and and are looking forward to to selecting lead antigens in the in the second half of the year. Speaker 400:37:10Great. Thank you for taking my questions. I appreciate it. Operator00:37:16Thank you. We are now going to proceed with our next question. And the questions come from the line of Swayampakula Ramakanth Please ask your question. Speaker 500:37:42Thank you. Good afternoon, Christian and Brigitte. Hey, Swayampakula Couple of hi. Couple of quick questions. The first one being on EBX zero one. Speaker 500:37:56So in terms of the data coming out, at AACR, what what what what sort of data should we be expecting? And then more importantly, as we wait for this for this, two year data point, coming up later in the year, based on your conversations with potential collaborators to date, you know, what what amount of data do you think eventually is sufficient for a transaction? Because this is a program that's been, that I think has produced pretty good set of data. So so what else are are people really looking for? Speaker 200:38:43I can start. So for the presentation at AACR, we will be presenting biomarker data and also additional T cell data from the patient. And we have already shared some of these earlier data, and we have now collected more samples and analyzed more samples from the patients. So it will be a more in-depth biomarker presentation at AACR. Speaker 100:39:14And then for the, you can say, data, what's needed? I I do think that the data that we are currently generating, and and also will be generating over the the remainder of the trial, that that is the data that we need. What is also then important for, for, you can say, a eventual transaction, that's definitely also there's a lot of, people waiting to see what are the data Merck and Moderna is gonna generate going to look like. And, of course, here, we we were pretty encouraged seeing that Moderna was out of the TG Carbon Conference earlier this year saying that they are anticipating approval in 2027, hence, continued good progress with their personalized cancer vaccine. And I would not expect that one would need to wait until approval, but we it will be interesting to see some of the early phase three data from from that trial. Speaker 100:40:24That that's clear that people are also awaiting awaiting that. So I I would say we have what what I feel is needed from an EVXO one one point of view, and then there's some level of comfort confirmation that those data would also hold up in a in a larger scale later stage phase three trial, which we hopefully will see later on this year. Perfect. Speaker 500:40:55And then regarding the ERV vaccines that that you plan to work on, what types of cancers could potentially be be be the indications that we could use these vaccines to evaluate? Speaker 200:41:17Yeah. Really good question. Okay. So we have worked with the ERV concept for quite some time now. We have looked into a lot of data from different cancer indications and have mapped out the indications where there is a high burden as recorded. Speaker 200:41:36And that has led to the development of this precision herb vaccine concept where we can see that in specific indications that these sequences are shared across the patients. And we have a list of of these cancer indications that we would like to work more on, and we will most likely also share some more information by the by the end of this year on on the possible indications to to move forward with. Speaker 500:42:13Okay. And then the last question from me, you know, regarding EVX b two and b three, you know, would would you be releasing any data ahead of, submitting, to MSD or as you're submitting to MSD for their decision, on exercising the option? Speaker 100:42:39No. You can say for for b two, MSD is, doing some confirmatory work on the data that we have generated. Hence, we will not be be releasing more data there. B three, that's the finalization of of the current of the work plan that we agreed in 2023 that that's being completed. And the major part of work there is with with MSD as well. Speaker 500:43:12Okay. Perfect. Thank you both. Thanks for taking all my questions. Speaker 100:43:16You're welcome. Good talking to Operator00:43:21As a reminder, to ask a question, please press 11 on your telephone and wait for your name to be announced. To withdraw your question, please press 11 again. Thank you. We have no further questions at the moment registered. So I will now hand back to Christian Kansrup for closing remarks. Speaker 100:43:49Thank you so much. And I just want to wrap up by saying thank you to all of you for listening in, and thank you for the questions as well. As already said, 2024 was a very exciting year, creating a strong foundation for 2025. We are now in execution mode and will be focusing on delivering on our key milestones for the year. So we are definitely looking very much forward to to 2025, and we'll, of course, make sure to keep you all up to date on all recent events, the of action. Speaker 100:44:29So once again, thank you so much for taking the time for listening in, and we will stay in touch. Operator00:44:36This concludes today's conference call. Thank you all for participating. You may now disconnect your lines. Thank you, and have a good day.Read morePowered by