NASDAQ:EVAX Evaxion Biotech A/S Q4 2023 Earnings Report $1.87 +0.14 (+8.09%) Closing price 03:56 PM EasternExtended Trading$1.82 -0.05 (-2.67%) As of 06:02 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. ProfileEarnings HistoryForecast Evaxion Biotech A/S EPS ResultsActual EPS-$0.80Consensus EPS N/ABeat/MissN/AOne Year Ago EPSN/AEvaxion Biotech A/S Revenue ResultsActual Revenue$0.07 millionExpected RevenueN/ABeat/MissN/AYoY Revenue GrowthN/AEvaxion Biotech A/S Announcement DetailsQuarterQ4 2023Date3/27/2024TimeN/AConference Call DateTuesday, April 2, 2024Conference Call Time9:00AM ETUpcoming EarningsEvaxion Biotech A/S' Q1 2025 earnings is scheduled for Tuesday, May 27, 2025, with a conference call scheduled at 9:30 AM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (20-F)Earnings HistoryCompany ProfilePowered by Evaxion Biotech A/S Q4 2023 Earnings Call TranscriptProvided by QuartrApril 2, 2024 ShareLink copied to clipboard.There are 8 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Evaxiom Business Update Conference Call Full Year 2023. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your speaker today, Christian Kannstrup. Operator00:00:34Please go ahead. Speaker 100:00:36Hello, everyone, and a very warm welcome to this Evaktion business update conference call on the back of our full year 2023 results. I'm Christian Kannstroop. I'm the CEO of Evaktion. With me today, I have Birgitte Rohenne, our Chief Scientific Officer. I have Jesper Nygren Niesen, our Chief Operating Officer and Chief Financial Officer. Speaker 100:01:02What we will be covering today is, I will be giving a brief welcome, also a brief corporate update. Then we will have Birgitte dive into the R and D and business update. And Jesper will be covering the 2023 financial results. After a few conclusive remarks by me, we will be heading into the Q and A session. So looking forward to an interactive session. Speaker 100:01:32Before getting started, I just want to direct your attention to the fact that we will be talking about the future today. And of course, when talking about the future that entails uncertainty. So I do direct your attention to the forward looking statement slide, which is contained in the presentation deck for today. With that, let me give you a brief summary of where we are today. First of all, we have refined our strategy. Speaker 100:02:06We have launched it and it's well anchored. And just to remind you, this is about a 3 pronged business model and I would touch upon it in a few seconds. Then we have also seen strong progress on our financing strategy. We have now cash into Q1 2025 secondured. We have MSD DHI as our largest shareholder, very pleased with that. Speaker 100:02:33We have also seen solid progress on our R and D and business strategy. We have reached a key milestone in the MSD vaccine collaboration. We have our precision vaccine project on track. And just today, we also released exciting and strong EBXB1 data. Across the business, we have been focusing on optimizing our cash burn, but important so without compromising our long term growth opportunities. Speaker 100:03:08That also entails that we have been optimizing the organization and we are focusing on investing for maximum return on investment. So all in all, I would say we are very pleased with where we are at this point in time in the Evacuation journey. Let me just give you a brief corporate update. I just wanted to recap a little bit on our strategy and our refined strategy. We have a 3 pronged business model, which is based upon our AI immunology platform. Speaker 100:03:45Important here is also that we are having a multi partner approach to value realization. So when you look at our strategy, the core of the strategy that is the AI immunology platform, our leading and validated platform for fast and effective design or discovery, design and development of novel vaccines. Based upon this platform, we have the 3 pronged business model to realize value. 1 is targets, 1 is pipeline and 1 is respond business. The target piece that's around a multi partner approach focusing around either single or multiple target discovery, design and development agreements. Speaker 100:04:31And here the MSD vaccine collaboration we have is a good example of what we want to achieve within the target prong of our business model. Then we have our pipeline. This is about our own development for select high value programs, bringing these programs to a major value inflection point before we pursue partnering. And here, of course, we are excited about the upcoming 1 year Phase 2 data for EBX-one, which we expect in the Q3. Finally, we have the responder prong, which is really about utilizing our core capabilities within data and predictive capabilities to develop responder models. Speaker 100:05:16And here we had the proof of principle for our checkpoint inhibitor model in the Q4 last year and are looking to progress that in a partnership based approach. So, our strategy core AI immunology and then it's about targets, pipeline and responders in a multi partner approach. Then a brief update on our financing strategy, which has been a key element to progress that over the past months here. And I'm very pleased to see the strong progress have seen here. In December 23, we closed a $5,300,000 private placement. Speaker 100:05:58Here we welcomed MSD, Global Health Innovation Fund, as a shareholder, very pleased to see MSD on the cap table. In February, we closed a $15,000,000 gross public offering. Also here, we had MSD GHI participating. And that now means that MSD GHI is the largest shareholder of Evaxion with just below 15% ownership. In parallel with this, we have been intensifying our focus on value realization via partnering. Speaker 100:06:34We have the ambition to fund our 2024 operational cash burn of $14,000,000 via business development income. And to do so, it's critical that we have the right focus on advancing various partnership discussions. So all in all, a significant progress on our financing strategy. And as I said, cash into Q1 2025. So that was the brief corporate update I wanted to give before handing over to Birgitte to have Birgitte give us an update on all the exciting things that have happened within the R and D side of the business over the past months. Speaker 100:07:15Birgitte, will you take it from here? Speaker 200:07:18Yes. Thank you, Christian. So today, I'm excited to give an update on the recent progress achieved in phone specific R and D pipeline programs. So let's turn to Slide 9. We have communicated initial encouraging data from our EVX-one personalized cancer vaccine Phase 2 trial. Speaker 200:07:41We have increased our focus on developing a precision cancer vaccine with broad applicability. For our BVX B1 step aureus vaccine, we have completed studies with an undisclosed partner testing our AI immunology designed antigens in a large animal model of surgical site infection. Further, we've made significant progress in our EVX B3 vaccine development program with MSD reaching the first milestones. So if we turn to Slide 10, we see our pipeline and we are advancing vaccine candidates for both cancer and infectious diseases. And all these vaccines are designed based on our AI immunology platform. Speaker 200:08:40Our pipeline includes several vaccine candidates, candidates at various stages of development and that exemplifies our commitment to saving and improving lives with AI immunology. If we look at our EVX-one Phase 2 trial on Slide 11, This is our most advanced program in metastatic melanoma. And for each patient that is involved in the trial, we manufacture a tailored vaccine that is fitting the tumor profile and the immune system of the individual patients. Once the patients are enrolled, they are administered with anti PD-one pembrolizumab, which is the standard of care for this indication. And then they're treated with our personalized EBX-one vaccine at week 12. Speaker 200:09:36If we move to Slide 12, we have monitored the ability of the EVX-one vaccine to induce a specific T cell response in the first five patients. And on the graph to the right, you see the data from these initial analysis. In all of the 5 patients we've assessed so far, we see a strong and specific response against the vaccine antigen. And further, we have confirmed the favorable safety profile of EVX-one, which we also observed in the Phase 1 study. And the next significant milestone is 1 year clinical readout in Q3 this year. Speaker 200:10:29So on Slide 13, we have a little bit of information about one of our cancer vaccine innovation programs. We have intensified our efforts significantly for this program and based on the discovery of the highly conserved novel class of tumor antigens, so called endogenous retroviruses, we have developed a precision based cancer vaccine concept with potential to broaden the applicability and to treat more cancer patients with a vaccine. Upcoming milestone for this program is preclinical proof of concept in Q4 'twenty four. So if we turn to our infectious disease program, on Slide 14, we have a little bit of highlights from our B1 project. This morning, as Christian mentioned, we announced that we have some very encouraging results from this program against staphylococcus aureus infection. Speaker 200:11:48So we and an undisclosed collaborator, we tested our vaccine antigens against staphylococcus aureus in a clinically relevant animal model of surgical site infections. And we saw that our antigens, they protected the animals against surgical site infections, indicating promising potential for clinical efficacy. And currently, we are engaged in discussions with the collaborate later regarding the path forward. So for our EBXO B3 program, we have tested or we have designed a vaccine and this program is conducted in collaboration with MSD. We have used our proprietary platform, AI Immunology and we have identified novel targets against a bacterial pathogen causing severe health issues. Speaker 200:12:55So we have now concluded on the antigen discovery and enzyme phases and that marks a significant first milestone for the development of the vaccine candidate. And next milestone is conclusion on target discovery and validation work in collaboration with MSD in the second half of twenty twenty four. So in summary, we've made substantial progress across our pipeline candidates and we are eagerly anticipating and inciting 2024 marked by some significant milestones ahead. Speaker 100:13:42Ian, thank you so much for this update. Truly exciting events that has taken place here. And now I will hand over to COO and CFO, Jesper Njegard Nesen to take us through the 2023 financial results. Thank you, Christian. Speaker 300:14:00I will focus my comments on our financial results for the full year of 2023 compared to the full year of 2022. All the numbers that I review will be approximate for easy sharing during the call. For additional information regarding our full year results and prior period comparisons, please refer to the business update and full year 2023 financial results press release and the Form 6 ks as well as the Form 20F that we both filed last week. Starting with our cash burn, this we have in 2023, as Christian talked to, had focused on optimizing without compromising our long term growth opportunities. The external spend as well as the organization has been slimmed to reflect our focused strategy and intensified focus on value realization via partnering. Speaker 300:14:56We have reduced the organization in terms of FTEs to the tune of 30% during 2023 and more than half the cash burn when comparing to cash burn entailed in the approved budget for 2023 to the expected cash burn shared as part of the company milestones for 2024. As of December 31, 2023, cash and cash equivalents were USD5,600,000 following the public offering in February 2024, resulting in net proceeds of USD12,700,000 We expect that our existing cash and cash equivalents will be sufficient to fund our operation and capital expenditure requirements into February 2025. If all pre funded borrowings including the public offering exercised, we expect necessary funding will be in place into April 2025. If we look at our expenses, research and development expenses for 2023 amounted to €11,900,000 and general and administrative expenses to $10,400,000 for the period. R and D expenses decreased by $5,100,000 or about 30% compared to 2022. Speaker 300:16:10The decrease was primarily driven by a decrease in external development cost of $3,200,000 related to clinical trials. Further, a decrease were seen in employee related cost of $1,800,000 due to a reduced headcount and a shift in our employee mix. Looking at general and administrative expenses, they were at 10,400,000, dollars an increase of $2,200,000 or 27% compared to the period last year. The increase was primarily driven by an increase of $1,300,000 in external costs related to legal fees, professional fees and costs related to capital raises and an increase in employee related cost of $1,900,000 related to full time effect of 2022 hires and changes in senior management. These increases are due to the timing of funding and of projects and business initiatives compared to 2022 and the expansions of the organization throughout 2022 to meet the requirements as a listed company. Speaker 300:17:13Looking solely at Q4 2023 versus Q4 2022, the G and A cost were down US0.3 million dollars to US2.1 million dollars or 13%. This is primarily driven by reduction in our D and O insurance, but also following reduction in other external spends. The net loss for 2023 amounted to a loss of $22,100,000 compared to a net loss of $23,200,000 last year. And with that, I would like to turn back to you Christian for a few conclusive remarks before the Q and A. Speaker 100:17:47Thank you so much Jesper. And to end up here with a few conclusive remarks, I think if we look at the past 6 months in the Evacian journey here, I think it's fair to say that the events we have seen unfolding confirms a strong strategy execution. We launched our refined strategy. We anchored that and we are now executing upon it. Importantly, of course, as Birgitte also alluded to the progress with the MSD vaccine collaboration, we had the encouraging initial Phase II data from EBXO-one, and we are progressing our precision vaccine project, which I'm very excited about. Speaker 100:18:37So strong progress on the strategy execution, and we are looking very much forward towards the upcoming milestones in 2024. The first milestone we had in our externally communicated milestone was SCORSE EBXB1, the conclusion of the final MTA study with a potential pattern that we announced today with encouraging data. Now we are in discussions with the collaborator on path forward. Throughout the remainder of the year, we would have several important milestones, both from a platform, from a compound and from a partnership point of view. And we are looking forward to keeping you all updated on the milestones as we progress them. Speaker 100:19:25So with that, I would say thank you for listening to the presentation here. And now I'm looking forward to the Q and A session and we will open the floor for questions. Operator00:19:39Thank you. And the first question comes from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Your line is now open. Speaker 400:20:05Good morning. Thank you so much for taking my questions. I have couple. My first question is regarding the today's press release on EBXB1, EBXB1. Curious if you could provide more color on the collaboration as well as data. Speaker 400:20:21Is this the point where there will be a go, no go decision? And if the collaborator is not willing to move forward, are you planning to move forward? Or is it something that you're not willing to do at this point? Speaker 100:20:35Yes. No, I mean, I can say and then I'll have Brigitte add additional comments. I mean, we just got the data in and we're excited to see the data. And as you also see in the release, it is, I would say, clinically relevant data here. And now we are in discussion of path forward. Speaker 100:20:59And of course, it's clear having a set of preclinical data in a large non rodent model is important, especially considering you can say that Staph aureus is an area where you have seen a number of clinical failures. So having a model, which hopefully is more predictive for clinical outcome is important. So right now, we are in discussion with a collaborator. And I would say the data is, of course, supportive of the compound. And Brigitte, I don't know if you have more comments to add to the question here. Speaker 200:21:37I can add that we have conducted 3 separate studies in this animal model. And I think the data speaks for itself. I mean, it's very promising. And we believe that this model is, I would say, a better indicator for clinical efficacy in the end. I mean, we've conducted mouse animal experiments in the past and with also very promising outcome. Speaker 200:22:06But I believe that this model in large non rodent animals, it gives a better sign of what we hope to see in a clinical trial. And of course, we think this point is very important because it will be the conclusion on or the dialogue with the collaborator is, of course, only relevant if the data was positive. Speaker 100:22:34So you can say, of course, it confirms our belief in a strong asset. And of course, it's important for our engaging in discussions around the way forward for this EVA XP1 in partnership based model. Speaker 400:22:54Makes sense. Thanks, Christian. And I have 2 other questions. The other question I have is on EVX B3. So since it's a major collaborator MSC, curious what are the next steps and when there will be a point to make decision, is it sometime in the near term future? Speaker 100:23:15Vicky, do you want to take that one? Speaker 200:23:17So what we have done so far is to use AI immunology to design the vaccine. And the next phase is to manufacture the vaccine and then test it in preclinical models. And we are aiming to reach that by the end of the year. Speaker 400:23:39I see. Sounds great. And my last question is more general. So since the platform technology you have is versatile, you have Pioneer, Eden, Observe, Raven. So curious if you get any inbounding interest or when you reach out, is there one particular vertical you have more special interest by the pharma or biotech firms. Speaker 400:24:05So when you are establishing partnership, is there one that's more emphasized in your conversation? Speaker 100:24:14I would say, first of all, of course, we have been more focused in our external communication as a result of also refining strategy, focusing more on partnerships. And that has, of course, also resulted in more incoming requests. And I would say, we are seeing interest in both the infectious disease side of the business and the oncology or cancer side of business. So I would not say that it's tilted more towards 1 or the other. And Brigitte, of course, you are just in Washington now for the World Vaccine Conference. Speaker 100:24:57So I don't know if you have a little bit of flavor as well. Speaker 200:25:00Yes. But I think so our AI immunology platform, I think that the companies can see the benefit of us using all these different building blocks and make or create models that can solve complex immune related health care issues. We have interest in our infectious disease pipeline candidates, but we also see interest in our oncology assets. So I think it will be difficult to answer more specifically than that. Speaker 100:25:41But of course, as you know, then we had the R and D Day, what's that now, a couple of weeks ago. And this was first time we really talked about this, I think, pretty unique modular architecture of with the various building blocks. And that was also important for understanding what the platform can do and how flexible it is in tailoring it towards partner needs. Speaker 400:26:09Makes sense. Thank you so much for taking my questions. Speaker 100:26:12Thanks. Operator00:26:14Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Swayampakula Ramakanth from H. C. Operator00:26:28Wainwright. Please go ahead. Your line is now open. Speaker 500:26:32Thank you. This is RK from HC Vanwright. Good afternoon, folks. Speaker 100:26:37Hey, RK. Speaker 500:26:40Hi. So starting off with EVX B3, so once MSD takes this into the clinic, do you have any additional obligations in terms of developing the molecule? And also, as it enters the clinic, do you get another milestone or is it all dependent on how it progresses through the clinical phases that you get milestone payments? Speaker 100:27:11Dependent upon the outcome of the current, you can say, discovery design phase here, which then, if successful and of course, if aligned with what the MSD is seeing, then that would result in a traditional licensing agreement. And the level of involvement from our end there is to be discussed and determined at that point in time. Right now, we have a work plan which spans into the second half of this year. And then we will be discussing how do we best combine our capabilities of the 2 companies for the next phases of the vaccine development project. I think it's fair to say, MSD is, of course, very capable in doing larger scale clinical trials, but we also have a lot to add in other phases than just the AI immunology platform itself. Speaker 100:28:14So it should be decided based upon the outcome when we conclude the work here during the second half. Speaker 500:28:24Fantastic. And then the EVX B1, obviously, it's very encouraging to see the way the data is progressing in large animals, also reiterating what you had seen in the mouse model. So when do you think you would be able to publish some of this data for us to take a look at? And then obviously, it depends on the partner, but what are the how quickly can this get into the clinic or again, it all depends upon how your collaborator is looking at it? Because this is certainly a very, very I think it's a large unmet need, especially in the surgical wounds. Speaker 100:29:15Yes. No, there's no doubt. I mean, that's also why we are excited about the data because there is a significant unmet need. And you can say exactly when data will be published, it depends very much on how we are progressing the current discussions and with whom we bring this forward. But of course, our objective is to progress quickly given the unmet need. Speaker 100:29:46And Birgitte, you can speak a little bit more to how quickly it can be in the clinic. Of course, it is our most progressed infectious disease assets, right? Speaker 200:29:57Yes. So the next steps would be the final IND enabling activities. So that includes toxicology studies and also the CMC activities. And that is, of course, time consuming activities. It will probably take 1 year, 1 to 1.5 year to get to the point where clinical trial could be initiated. Speaker 500:30:26Okay. Thank you. And the last question for me is on the Eden version 2, the new AI model that you're working on, what's unique about this version compared to the first one? Speaker 100:30:40I mean, the unique part about the 5 point 0 that we are looking to launch mid this year is that it incorporates some of the newer building blocks that we also discussed in our R and D Day and thereby, you can say, in short, further increases the predicted capabilities of the Eaton platform, which already is high, but will be even stronger. So it's allowing for, say, even more effective discovery of novel vaccines towards infectious diseases. Speaker 200:31:22And we also expand the training data set significantly and thereby increasing the precision of the model. Speaker 500:31:34Great. Thank you. Thank you for taking my questions. Speaker 100:31:37Thank you, RK. Operator00:31:39Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead. Operator00:31:54Your line is now open. Speaker 600:31:56Hey, guys. Appreciate you taking the question. On the preclinical work you're doing on the IRFs, I was curious if there are any particular tumor models that you're focusing on or are you doing more of a basket approach just to refine a future strategy at Speaker 100:32:14this point? Brigitte, do you want to take that? Yes. That has been discussed. Speaker 400:32:19Yes. Speaker 200:32:21So right now, we are looking into several indications for the IRF based cancer vaccines. And we do see several options, which is very encouraging and very promising. We haven't selected one single indication yet. We might run with a few. And therefore, we haven't settled on the animal model or the mouse model for testing this concept. Speaker 200:32:51And we do have a huge collection of animal tumor models in house. And therefore, I think we can move once we have decided on the indication, we can move rapidly into the preclinical testing. And I should also mention that we have done a vaccination in animals before. So we do have experience with these types of antigens in preclinical settings. Speaker 600:33:25Got it. Appreciate that. And have you had any interest whether inbound or generated through your efforts in the EVX-three program? Speaker 100:33:34Well, I think it's we can't really comment specifically on individual assets. But as we talked about, there are I mean, there's discussions in general around both sides of the business. So and I think we share a lot of excitement around EBX-three. And it's, of course, a key asset for us that we also want to move forward in a partnership based approach. I mean, we did announce that we won't bring it into clinical development ourselves, but that does definitely not mean that we don't want to bring it forward in a partnership based approach. Speaker 600:34:13Got it. I appreciate you taking the questions. Thank you. Thanks, Oliver. Operator00:34:19We will now take our next question. Please stand by. And the next question comes from the line of Richard Ramnanius from Rediet. Please go ahead. Your line is now open. Speaker 700:34:36Hello, good afternoon. The first financing question, namely about the prefunded warrants. How many are still outstanding? And how much money do you expect to get from them? And when could you expect to receive that money? Speaker 100:34:58Yes. You can say it's around $4,000,000 that's still outstanding. And this is related to the technicality that the nominal value of the underlying share for the warrant is held in escrow. So it's around US4 $1,000,000 that we haven't received yet, and we will receive that as the prefunded warrants are exercised. You can say exactly when that is going to happen is difficult to predict. Speaker 100:35:34But of course, it is shares that's paid upfront. So we would expect that those $4,000,000 are being released from escrow over time, right? Speaker 700:35:51Okay. And I also wonder about Urb vaccines and how what is your business development model there? Because you're doing precision vaccines, when do you think it would be possible to do a deal there? What kind of interest do you see for precision vaccines in cancer? Speaker 100:36:21But I think there's a lot of excitement in general around the IRF based concept and also the precision vaccine, I think question is here, when we want to partner and that also depends on how do the preclinical data that we will be generating when we establish proof of concept during second half, how do they look? It doesn't make sense to bring these assets further. So I would say, right now, focus is on establishing the preclinical proof of concept for the precision based vaccine concept and then decide when is the right time to partner. As Birgitte said, I mean, there are several indications where it shows high promise to have a precision based approach. So we'll need to look at the data, compare that to the opportunity and then decide what's the right timing for potential partnering. Speaker 700:37:27Would you agree that there is a larger interest right now for infectious disease candidates than for cancer? Speaker 100:37:36No, I wouldn't say that. I think there's equally element of not only personalized vaccines, but also precision based vaccines within the cancer side of the business, which is somewhat different approach than having a personalized approach. So I wouldn't say that there's necessarily more interest in infectious diseases. There's a good level of excitement around both sides. And of course, it's also clear that some of our competitors' data on the personalized vaccines that was announced last year have created additional comfort that this is an exciting area where it makes sense to focus on. Speaker 700:38:29Yes. And I also wanted to ask about the AI deep or responder program you have, specifically one for checkpoint inhibitors. Because I was thinking since in the indications for certain approved uses in various cancers, it says you need to have a certain level or a certain level of biomarker for PD-one L1 levels. So would this if this could be your approach were approved, that would be quite disruptive. Wouldn't doesn't that mean you would have to sort of redefine how you make indications for checkpoint inhibitors? Speaker 700:39:21That's my first question. My second related is how what is your monetization model? How I mean, how could you earn money on this? Speaker 100:39:33Yes. Birgitte, do you want to take the first part and then I can talk about the second part? Yes. Speaker 200:39:39I can do that. So yes, it is correct that PD L1 tumor expression is yes a biomarker for some cancer indication, including non small cell lung cancer and some of the other huge cancers. And we have also in our AID model, we have also included the expression level of PD L1. And we see that it is only contributing to a minor part of the whole precision of the AI model. It's mainly driven by our PIONEER model and our observed model. Speaker 200:40:21But it is correct that for some indications, the PD L1 expression is used as a treatment Speaker 100:40:32biomarker. Speaker 700:40:35Just wondering how would you have to change how you treat people if your checkpoint response prediction tool is approved? Speaker 200:40:44So what AID is capable of is to identify the patients that most likely would not benefit from a checkpoint inhibitor treatment. So we'll not risk of excluding patients that would benefit from checkpoint inhibitors. Speaker 700:41:11Okay. I understand. Speaker 100:41:13And then to your question around how to monetize on that, I mean, that can be done in several way. Of course, you can say the most straightforward one is positioning as a companion diagnostics, and then it's being sold into other clinical setting or it could also, of course, be of relevance for pharma companies undertaking clinical trials with checkpoint inhibitors because if you are capable of, say, reducing the trial population of a late stage trial by upfront being able to exclude non responders that that means a significant cost saving. But I think where our focus is right now is focusing on how we can bring it forward in a clinical setting and help patients get on to the right therapy quicker. And that could be as a companion diagnostic. Speaker 700:42:16Yes. I think this is an interesting project you have. And my last question was, do you have any policy for takeover bids because it slips easy to your mind when you see the investments that MSC has made, logical steps there might be to try to make an acquisition? Speaker 100:42:41Yes. And of course, we can't comment upon any question like that. If something relevant is to be communicated, of course, we will communicate that. Speaker 700:42:55Okay. Thanks. Those were all my questions. Operator00:43:03Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Operator00:43:16Your line is now open. Speaker 400:43:19Hello again. I just wanted to ask one more question regarding the odd outstanding debt. What is the current debt on the financial front? Speaker 100:43:30And I'm very happy to pass that question straight on to our CFO, but I can say it's an EIB loan. Speaker 300:43:39Yes. So basically, our debt structure is pretty simple. We have an EIB loan, which is of €7,000,000 and it has an expiry date of Q1, 2028. Speaker 400:43:57Got it. Okay. Thank you very much. Operator00:44:02Thank you. As there are no further questions, I would like to hand back to Christian Kantstrup for any closing remarks. Please go ahead. Speaker 100:44:13Yes. Thank you so much. And I just want to say thank you to all of you for all the relevant and good questions. And thank you for listening in. We are excited about what has happened over the past several months here and equally excited about what's to come for 2024. Speaker 100:44:33And we are looking forward to keeping you updated on that. So thank you so much for listening in.Read morePowered by Key Takeaways Evaxion has refined its strategy around a three-pronged business model—AI immunology platform as the core, with targets (multi-partner discovery deals like the MSD vaccine collaboration), pipeline (own high-value programs) and responders (predictive models) to realize value. The company secured cash runway into Q1 2025 via a $5.3 million private placement and a $15 million public offering, with MSD Global Health Innovation Fund now holding just under 15% of the company. In the EVX-one Phase 2 metastatic melanoma trial, personalized vaccine doses induced strong, specific T-cell responses in the first five patients and maintained a favorable safety profile, with a one-year clinical readout expected in Q3 2024. Evaxion’s infectious disease portfolio advanced as its EBX-B1 Staphylococcus aureus vaccine demonstrated protective efficacy in a large animal surgical site infection model, and the EBX-B3 program with MSD reached its first antigen discovery and design milestones. The company optimized operations in 2023 by reducing headcount by 30% and cutting cash burn by over 50% versus budget, reporting a net loss of $22.1 million for the year while preserving long-term growth prospects. AI Generated. May Contain Errors.Conference Call Audio Live Call not available Earnings Conference CallEvaxion Biotech A/S Q4 202300:00 / 00:00Speed:1x1.25x1.5x2x Earnings DocumentsPress Release(8-K)Annual report(20-F) Evaxion Biotech A/S Earnings HeadlinesEvaxion doses first patient in extension of phase 2 trial exploring the full potential of AI-designed personalized cancer vaccine EVX-01May 22 at 8:00 AM | globenewswire.comEvaxion A/S ADRMay 21 at 4:16 PM | wsj.comA grave, grave error.I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. May 22, 2025 | Porter & Company (Ad)Evaxion Biotech A/S (EVAX) to Release Quarterly Earnings on TuesdayMay 20 at 1:54 AM | americanbankingnews.comEvaxion Biotech A/S Announces Key Resolutions from April 2025 AGMMay 5, 2025 | tipranks.comEvaxion Reports Positive Data For Vaccine Candidate EVX-01April 30, 2025 | nasdaq.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 Alibaba's Earnings Just Changed Everything for the StockCisco Stock Eyes New Highs in 2025 on AI, Earnings, UpgradesSymbotic Gets Big Earnings Lift: Is the Stock Investable Again?D-Wave Pushes Back on Short Seller Case With Strong EarningsAppLovin Surges on Earnings: What's Next for This Tech Standout?Can Shopify Stock Make a Comeback After an Earnings Sell-Off?Rocket Lab: Earnings Miss But Neutron Momentum Holds Upcoming Earnings PDD (5/27/2025)AutoZone (5/27/2025)Bank of Nova Scotia (5/27/2025)NVIDIA (5/28/2025)Synopsys (5/28/2025)Bank of Montreal (5/28/2025)Salesforce (5/28/2025)Costco Wholesale (5/29/2025)Marvell Technology (5/29/2025)Canadian Imperial Bank of Commerce (5/29/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. 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There are 8 speakers on the call. Operator00:00:00Good day, and thank you for standing by. Welcome to the Evaxiom Business Update Conference Call Full Year 2023. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your speaker today, Christian Kannstrup. Operator00:00:34Please go ahead. Speaker 100:00:36Hello, everyone, and a very warm welcome to this Evaktion business update conference call on the back of our full year 2023 results. I'm Christian Kannstroop. I'm the CEO of Evaktion. With me today, I have Birgitte Rohenne, our Chief Scientific Officer. I have Jesper Nygren Niesen, our Chief Operating Officer and Chief Financial Officer. Speaker 100:01:02What we will be covering today is, I will be giving a brief welcome, also a brief corporate update. Then we will have Birgitte dive into the R and D and business update. And Jesper will be covering the 2023 financial results. After a few conclusive remarks by me, we will be heading into the Q and A session. So looking forward to an interactive session. Speaker 100:01:32Before getting started, I just want to direct your attention to the fact that we will be talking about the future today. And of course, when talking about the future that entails uncertainty. So I do direct your attention to the forward looking statement slide, which is contained in the presentation deck for today. With that, let me give you a brief summary of where we are today. First of all, we have refined our strategy. Speaker 100:02:06We have launched it and it's well anchored. And just to remind you, this is about a 3 pronged business model and I would touch upon it in a few seconds. Then we have also seen strong progress on our financing strategy. We have now cash into Q1 2025 secondured. We have MSD DHI as our largest shareholder, very pleased with that. Speaker 100:02:33We have also seen solid progress on our R and D and business strategy. We have reached a key milestone in the MSD vaccine collaboration. We have our precision vaccine project on track. And just today, we also released exciting and strong EBXB1 data. Across the business, we have been focusing on optimizing our cash burn, but important so without compromising our long term growth opportunities. Speaker 100:03:08That also entails that we have been optimizing the organization and we are focusing on investing for maximum return on investment. So all in all, I would say we are very pleased with where we are at this point in time in the Evacuation journey. Let me just give you a brief corporate update. I just wanted to recap a little bit on our strategy and our refined strategy. We have a 3 pronged business model, which is based upon our AI immunology platform. Speaker 100:03:45Important here is also that we are having a multi partner approach to value realization. So when you look at our strategy, the core of the strategy that is the AI immunology platform, our leading and validated platform for fast and effective design or discovery, design and development of novel vaccines. Based upon this platform, we have the 3 pronged business model to realize value. 1 is targets, 1 is pipeline and 1 is respond business. The target piece that's around a multi partner approach focusing around either single or multiple target discovery, design and development agreements. Speaker 100:04:31And here the MSD vaccine collaboration we have is a good example of what we want to achieve within the target prong of our business model. Then we have our pipeline. This is about our own development for select high value programs, bringing these programs to a major value inflection point before we pursue partnering. And here, of course, we are excited about the upcoming 1 year Phase 2 data for EBX-one, which we expect in the Q3. Finally, we have the responder prong, which is really about utilizing our core capabilities within data and predictive capabilities to develop responder models. Speaker 100:05:16And here we had the proof of principle for our checkpoint inhibitor model in the Q4 last year and are looking to progress that in a partnership based approach. So, our strategy core AI immunology and then it's about targets, pipeline and responders in a multi partner approach. Then a brief update on our financing strategy, which has been a key element to progress that over the past months here. And I'm very pleased to see the strong progress have seen here. In December 23, we closed a $5,300,000 private placement. Speaker 100:05:58Here we welcomed MSD, Global Health Innovation Fund, as a shareholder, very pleased to see MSD on the cap table. In February, we closed a $15,000,000 gross public offering. Also here, we had MSD GHI participating. And that now means that MSD GHI is the largest shareholder of Evaxion with just below 15% ownership. In parallel with this, we have been intensifying our focus on value realization via partnering. Speaker 100:06:34We have the ambition to fund our 2024 operational cash burn of $14,000,000 via business development income. And to do so, it's critical that we have the right focus on advancing various partnership discussions. So all in all, a significant progress on our financing strategy. And as I said, cash into Q1 2025. So that was the brief corporate update I wanted to give before handing over to Birgitte to have Birgitte give us an update on all the exciting things that have happened within the R and D side of the business over the past months. Speaker 100:07:15Birgitte, will you take it from here? Speaker 200:07:18Yes. Thank you, Christian. So today, I'm excited to give an update on the recent progress achieved in phone specific R and D pipeline programs. So let's turn to Slide 9. We have communicated initial encouraging data from our EVX-one personalized cancer vaccine Phase 2 trial. Speaker 200:07:41We have increased our focus on developing a precision cancer vaccine with broad applicability. For our BVX B1 step aureus vaccine, we have completed studies with an undisclosed partner testing our AI immunology designed antigens in a large animal model of surgical site infection. Further, we've made significant progress in our EVX B3 vaccine development program with MSD reaching the first milestones. So if we turn to Slide 10, we see our pipeline and we are advancing vaccine candidates for both cancer and infectious diseases. And all these vaccines are designed based on our AI immunology platform. Speaker 200:08:40Our pipeline includes several vaccine candidates, candidates at various stages of development and that exemplifies our commitment to saving and improving lives with AI immunology. If we look at our EVX-one Phase 2 trial on Slide 11, This is our most advanced program in metastatic melanoma. And for each patient that is involved in the trial, we manufacture a tailored vaccine that is fitting the tumor profile and the immune system of the individual patients. Once the patients are enrolled, they are administered with anti PD-one pembrolizumab, which is the standard of care for this indication. And then they're treated with our personalized EBX-one vaccine at week 12. Speaker 200:09:36If we move to Slide 12, we have monitored the ability of the EVX-one vaccine to induce a specific T cell response in the first five patients. And on the graph to the right, you see the data from these initial analysis. In all of the 5 patients we've assessed so far, we see a strong and specific response against the vaccine antigen. And further, we have confirmed the favorable safety profile of EVX-one, which we also observed in the Phase 1 study. And the next significant milestone is 1 year clinical readout in Q3 this year. Speaker 200:10:29So on Slide 13, we have a little bit of information about one of our cancer vaccine innovation programs. We have intensified our efforts significantly for this program and based on the discovery of the highly conserved novel class of tumor antigens, so called endogenous retroviruses, we have developed a precision based cancer vaccine concept with potential to broaden the applicability and to treat more cancer patients with a vaccine. Upcoming milestone for this program is preclinical proof of concept in Q4 'twenty four. So if we turn to our infectious disease program, on Slide 14, we have a little bit of highlights from our B1 project. This morning, as Christian mentioned, we announced that we have some very encouraging results from this program against staphylococcus aureus infection. Speaker 200:11:48So we and an undisclosed collaborator, we tested our vaccine antigens against staphylococcus aureus in a clinically relevant animal model of surgical site infections. And we saw that our antigens, they protected the animals against surgical site infections, indicating promising potential for clinical efficacy. And currently, we are engaged in discussions with the collaborate later regarding the path forward. So for our EBXO B3 program, we have tested or we have designed a vaccine and this program is conducted in collaboration with MSD. We have used our proprietary platform, AI Immunology and we have identified novel targets against a bacterial pathogen causing severe health issues. Speaker 200:12:55So we have now concluded on the antigen discovery and enzyme phases and that marks a significant first milestone for the development of the vaccine candidate. And next milestone is conclusion on target discovery and validation work in collaboration with MSD in the second half of twenty twenty four. So in summary, we've made substantial progress across our pipeline candidates and we are eagerly anticipating and inciting 2024 marked by some significant milestones ahead. Speaker 100:13:42Ian, thank you so much for this update. Truly exciting events that has taken place here. And now I will hand over to COO and CFO, Jesper Njegard Nesen to take us through the 2023 financial results. Thank you, Christian. Speaker 300:14:00I will focus my comments on our financial results for the full year of 2023 compared to the full year of 2022. All the numbers that I review will be approximate for easy sharing during the call. For additional information regarding our full year results and prior period comparisons, please refer to the business update and full year 2023 financial results press release and the Form 6 ks as well as the Form 20F that we both filed last week. Starting with our cash burn, this we have in 2023, as Christian talked to, had focused on optimizing without compromising our long term growth opportunities. The external spend as well as the organization has been slimmed to reflect our focused strategy and intensified focus on value realization via partnering. Speaker 300:14:56We have reduced the organization in terms of FTEs to the tune of 30% during 2023 and more than half the cash burn when comparing to cash burn entailed in the approved budget for 2023 to the expected cash burn shared as part of the company milestones for 2024. As of December 31, 2023, cash and cash equivalents were USD5,600,000 following the public offering in February 2024, resulting in net proceeds of USD12,700,000 We expect that our existing cash and cash equivalents will be sufficient to fund our operation and capital expenditure requirements into February 2025. If all pre funded borrowings including the public offering exercised, we expect necessary funding will be in place into April 2025. If we look at our expenses, research and development expenses for 2023 amounted to €11,900,000 and general and administrative expenses to $10,400,000 for the period. R and D expenses decreased by $5,100,000 or about 30% compared to 2022. Speaker 300:16:10The decrease was primarily driven by a decrease in external development cost of $3,200,000 related to clinical trials. Further, a decrease were seen in employee related cost of $1,800,000 due to a reduced headcount and a shift in our employee mix. Looking at general and administrative expenses, they were at 10,400,000, dollars an increase of $2,200,000 or 27% compared to the period last year. The increase was primarily driven by an increase of $1,300,000 in external costs related to legal fees, professional fees and costs related to capital raises and an increase in employee related cost of $1,900,000 related to full time effect of 2022 hires and changes in senior management. These increases are due to the timing of funding and of projects and business initiatives compared to 2022 and the expansions of the organization throughout 2022 to meet the requirements as a listed company. Speaker 300:17:13Looking solely at Q4 2023 versus Q4 2022, the G and A cost were down US0.3 million dollars to US2.1 million dollars or 13%. This is primarily driven by reduction in our D and O insurance, but also following reduction in other external spends. The net loss for 2023 amounted to a loss of $22,100,000 compared to a net loss of $23,200,000 last year. And with that, I would like to turn back to you Christian for a few conclusive remarks before the Q and A. Speaker 100:17:47Thank you so much Jesper. And to end up here with a few conclusive remarks, I think if we look at the past 6 months in the Evacian journey here, I think it's fair to say that the events we have seen unfolding confirms a strong strategy execution. We launched our refined strategy. We anchored that and we are now executing upon it. Importantly, of course, as Birgitte also alluded to the progress with the MSD vaccine collaboration, we had the encouraging initial Phase II data from EBXO-one, and we are progressing our precision vaccine project, which I'm very excited about. Speaker 100:18:37So strong progress on the strategy execution, and we are looking very much forward towards the upcoming milestones in 2024. The first milestone we had in our externally communicated milestone was SCORSE EBXB1, the conclusion of the final MTA study with a potential pattern that we announced today with encouraging data. Now we are in discussions with the collaborator on path forward. Throughout the remainder of the year, we would have several important milestones, both from a platform, from a compound and from a partnership point of view. And we are looking forward to keeping you all updated on the milestones as we progress them. Speaker 100:19:25So with that, I would say thank you for listening to the presentation here. And now I'm looking forward to the Q and A session and we will open the floor for questions. Operator00:19:39Thank you. And the first question comes from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Your line is now open. Speaker 400:20:05Good morning. Thank you so much for taking my questions. I have couple. My first question is regarding the today's press release on EBXB1, EBXB1. Curious if you could provide more color on the collaboration as well as data. Speaker 400:20:21Is this the point where there will be a go, no go decision? And if the collaborator is not willing to move forward, are you planning to move forward? Or is it something that you're not willing to do at this point? Speaker 100:20:35Yes. No, I mean, I can say and then I'll have Brigitte add additional comments. I mean, we just got the data in and we're excited to see the data. And as you also see in the release, it is, I would say, clinically relevant data here. And now we are in discussion of path forward. Speaker 100:20:59And of course, it's clear having a set of preclinical data in a large non rodent model is important, especially considering you can say that Staph aureus is an area where you have seen a number of clinical failures. So having a model, which hopefully is more predictive for clinical outcome is important. So right now, we are in discussion with a collaborator. And I would say the data is, of course, supportive of the compound. And Brigitte, I don't know if you have more comments to add to the question here. Speaker 200:21:37I can add that we have conducted 3 separate studies in this animal model. And I think the data speaks for itself. I mean, it's very promising. And we believe that this model is, I would say, a better indicator for clinical efficacy in the end. I mean, we've conducted mouse animal experiments in the past and with also very promising outcome. Speaker 200:22:06But I believe that this model in large non rodent animals, it gives a better sign of what we hope to see in a clinical trial. And of course, we think this point is very important because it will be the conclusion on or the dialogue with the collaborator is, of course, only relevant if the data was positive. Speaker 100:22:34So you can say, of course, it confirms our belief in a strong asset. And of course, it's important for our engaging in discussions around the way forward for this EVA XP1 in partnership based model. Speaker 400:22:54Makes sense. Thanks, Christian. And I have 2 other questions. The other question I have is on EVX B3. So since it's a major collaborator MSC, curious what are the next steps and when there will be a point to make decision, is it sometime in the near term future? Speaker 100:23:15Vicky, do you want to take that one? Speaker 200:23:17So what we have done so far is to use AI immunology to design the vaccine. And the next phase is to manufacture the vaccine and then test it in preclinical models. And we are aiming to reach that by the end of the year. Speaker 400:23:39I see. Sounds great. And my last question is more general. So since the platform technology you have is versatile, you have Pioneer, Eden, Observe, Raven. So curious if you get any inbounding interest or when you reach out, is there one particular vertical you have more special interest by the pharma or biotech firms. Speaker 400:24:05So when you are establishing partnership, is there one that's more emphasized in your conversation? Speaker 100:24:14I would say, first of all, of course, we have been more focused in our external communication as a result of also refining strategy, focusing more on partnerships. And that has, of course, also resulted in more incoming requests. And I would say, we are seeing interest in both the infectious disease side of the business and the oncology or cancer side of business. So I would not say that it's tilted more towards 1 or the other. And Brigitte, of course, you are just in Washington now for the World Vaccine Conference. Speaker 100:24:57So I don't know if you have a little bit of flavor as well. Speaker 200:25:00Yes. But I think so our AI immunology platform, I think that the companies can see the benefit of us using all these different building blocks and make or create models that can solve complex immune related health care issues. We have interest in our infectious disease pipeline candidates, but we also see interest in our oncology assets. So I think it will be difficult to answer more specifically than that. Speaker 100:25:41But of course, as you know, then we had the R and D Day, what's that now, a couple of weeks ago. And this was first time we really talked about this, I think, pretty unique modular architecture of with the various building blocks. And that was also important for understanding what the platform can do and how flexible it is in tailoring it towards partner needs. Speaker 400:26:09Makes sense. Thank you so much for taking my questions. Speaker 100:26:12Thanks. Operator00:26:14Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Swayampakula Ramakanth from H. C. Operator00:26:28Wainwright. Please go ahead. Your line is now open. Speaker 500:26:32Thank you. This is RK from HC Vanwright. Good afternoon, folks. Speaker 100:26:37Hey, RK. Speaker 500:26:40Hi. So starting off with EVX B3, so once MSD takes this into the clinic, do you have any additional obligations in terms of developing the molecule? And also, as it enters the clinic, do you get another milestone or is it all dependent on how it progresses through the clinical phases that you get milestone payments? Speaker 100:27:11Dependent upon the outcome of the current, you can say, discovery design phase here, which then, if successful and of course, if aligned with what the MSD is seeing, then that would result in a traditional licensing agreement. And the level of involvement from our end there is to be discussed and determined at that point in time. Right now, we have a work plan which spans into the second half of this year. And then we will be discussing how do we best combine our capabilities of the 2 companies for the next phases of the vaccine development project. I think it's fair to say, MSD is, of course, very capable in doing larger scale clinical trials, but we also have a lot to add in other phases than just the AI immunology platform itself. Speaker 100:28:14So it should be decided based upon the outcome when we conclude the work here during the second half. Speaker 500:28:24Fantastic. And then the EVX B1, obviously, it's very encouraging to see the way the data is progressing in large animals, also reiterating what you had seen in the mouse model. So when do you think you would be able to publish some of this data for us to take a look at? And then obviously, it depends on the partner, but what are the how quickly can this get into the clinic or again, it all depends upon how your collaborator is looking at it? Because this is certainly a very, very I think it's a large unmet need, especially in the surgical wounds. Speaker 100:29:15Yes. No, there's no doubt. I mean, that's also why we are excited about the data because there is a significant unmet need. And you can say exactly when data will be published, it depends very much on how we are progressing the current discussions and with whom we bring this forward. But of course, our objective is to progress quickly given the unmet need. Speaker 100:29:46And Birgitte, you can speak a little bit more to how quickly it can be in the clinic. Of course, it is our most progressed infectious disease assets, right? Speaker 200:29:57Yes. So the next steps would be the final IND enabling activities. So that includes toxicology studies and also the CMC activities. And that is, of course, time consuming activities. It will probably take 1 year, 1 to 1.5 year to get to the point where clinical trial could be initiated. Speaker 500:30:26Okay. Thank you. And the last question for me is on the Eden version 2, the new AI model that you're working on, what's unique about this version compared to the first one? Speaker 100:30:40I mean, the unique part about the 5 point 0 that we are looking to launch mid this year is that it incorporates some of the newer building blocks that we also discussed in our R and D Day and thereby, you can say, in short, further increases the predicted capabilities of the Eaton platform, which already is high, but will be even stronger. So it's allowing for, say, even more effective discovery of novel vaccines towards infectious diseases. Speaker 200:31:22And we also expand the training data set significantly and thereby increasing the precision of the model. Speaker 500:31:34Great. Thank you. Thank you for taking my questions. Speaker 100:31:37Thank you, RK. Operator00:31:39Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead. Operator00:31:54Your line is now open. Speaker 600:31:56Hey, guys. Appreciate you taking the question. On the preclinical work you're doing on the IRFs, I was curious if there are any particular tumor models that you're focusing on or are you doing more of a basket approach just to refine a future strategy at Speaker 100:32:14this point? Brigitte, do you want to take that? Yes. That has been discussed. Speaker 400:32:19Yes. Speaker 200:32:21So right now, we are looking into several indications for the IRF based cancer vaccines. And we do see several options, which is very encouraging and very promising. We haven't selected one single indication yet. We might run with a few. And therefore, we haven't settled on the animal model or the mouse model for testing this concept. Speaker 200:32:51And we do have a huge collection of animal tumor models in house. And therefore, I think we can move once we have decided on the indication, we can move rapidly into the preclinical testing. And I should also mention that we have done a vaccination in animals before. So we do have experience with these types of antigens in preclinical settings. Speaker 600:33:25Got it. Appreciate that. And have you had any interest whether inbound or generated through your efforts in the EVX-three program? Speaker 100:33:34Well, I think it's we can't really comment specifically on individual assets. But as we talked about, there are I mean, there's discussions in general around both sides of the business. So and I think we share a lot of excitement around EBX-three. And it's, of course, a key asset for us that we also want to move forward in a partnership based approach. I mean, we did announce that we won't bring it into clinical development ourselves, but that does definitely not mean that we don't want to bring it forward in a partnership based approach. Speaker 600:34:13Got it. I appreciate you taking the questions. Thank you. Thanks, Oliver. Operator00:34:19We will now take our next question. Please stand by. And the next question comes from the line of Richard Ramnanius from Rediet. Please go ahead. Your line is now open. Speaker 700:34:36Hello, good afternoon. The first financing question, namely about the prefunded warrants. How many are still outstanding? And how much money do you expect to get from them? And when could you expect to receive that money? Speaker 100:34:58Yes. You can say it's around $4,000,000 that's still outstanding. And this is related to the technicality that the nominal value of the underlying share for the warrant is held in escrow. So it's around US4 $1,000,000 that we haven't received yet, and we will receive that as the prefunded warrants are exercised. You can say exactly when that is going to happen is difficult to predict. Speaker 100:35:34But of course, it is shares that's paid upfront. So we would expect that those $4,000,000 are being released from escrow over time, right? Speaker 700:35:51Okay. And I also wonder about Urb vaccines and how what is your business development model there? Because you're doing precision vaccines, when do you think it would be possible to do a deal there? What kind of interest do you see for precision vaccines in cancer? Speaker 100:36:21But I think there's a lot of excitement in general around the IRF based concept and also the precision vaccine, I think question is here, when we want to partner and that also depends on how do the preclinical data that we will be generating when we establish proof of concept during second half, how do they look? It doesn't make sense to bring these assets further. So I would say, right now, focus is on establishing the preclinical proof of concept for the precision based vaccine concept and then decide when is the right time to partner. As Birgitte said, I mean, there are several indications where it shows high promise to have a precision based approach. So we'll need to look at the data, compare that to the opportunity and then decide what's the right timing for potential partnering. Speaker 700:37:27Would you agree that there is a larger interest right now for infectious disease candidates than for cancer? Speaker 100:37:36No, I wouldn't say that. I think there's equally element of not only personalized vaccines, but also precision based vaccines within the cancer side of the business, which is somewhat different approach than having a personalized approach. So I wouldn't say that there's necessarily more interest in infectious diseases. There's a good level of excitement around both sides. And of course, it's also clear that some of our competitors' data on the personalized vaccines that was announced last year have created additional comfort that this is an exciting area where it makes sense to focus on. Speaker 700:38:29Yes. And I also wanted to ask about the AI deep or responder program you have, specifically one for checkpoint inhibitors. Because I was thinking since in the indications for certain approved uses in various cancers, it says you need to have a certain level or a certain level of biomarker for PD-one L1 levels. So would this if this could be your approach were approved, that would be quite disruptive. Wouldn't doesn't that mean you would have to sort of redefine how you make indications for checkpoint inhibitors? Speaker 700:39:21That's my first question. My second related is how what is your monetization model? How I mean, how could you earn money on this? Speaker 100:39:33Yes. Birgitte, do you want to take the first part and then I can talk about the second part? Yes. Speaker 200:39:39I can do that. So yes, it is correct that PD L1 tumor expression is yes a biomarker for some cancer indication, including non small cell lung cancer and some of the other huge cancers. And we have also in our AID model, we have also included the expression level of PD L1. And we see that it is only contributing to a minor part of the whole precision of the AI model. It's mainly driven by our PIONEER model and our observed model. Speaker 200:40:21But it is correct that for some indications, the PD L1 expression is used as a treatment Speaker 100:40:32biomarker. Speaker 700:40:35Just wondering how would you have to change how you treat people if your checkpoint response prediction tool is approved? Speaker 200:40:44So what AID is capable of is to identify the patients that most likely would not benefit from a checkpoint inhibitor treatment. So we'll not risk of excluding patients that would benefit from checkpoint inhibitors. Speaker 700:41:11Okay. I understand. Speaker 100:41:13And then to your question around how to monetize on that, I mean, that can be done in several way. Of course, you can say the most straightforward one is positioning as a companion diagnostics, and then it's being sold into other clinical setting or it could also, of course, be of relevance for pharma companies undertaking clinical trials with checkpoint inhibitors because if you are capable of, say, reducing the trial population of a late stage trial by upfront being able to exclude non responders that that means a significant cost saving. But I think where our focus is right now is focusing on how we can bring it forward in a clinical setting and help patients get on to the right therapy quicker. And that could be as a companion diagnostic. Speaker 700:42:16Yes. I think this is an interesting project you have. And my last question was, do you have any policy for takeover bids because it slips easy to your mind when you see the investments that MSC has made, logical steps there might be to try to make an acquisition? Speaker 100:42:41Yes. And of course, we can't comment upon any question like that. If something relevant is to be communicated, of course, we will communicate that. Speaker 700:42:55Okay. Thanks. Those were all my questions. Operator00:43:03Thank you. We will now take our next question. Please stand by. And the next question comes from the line of Ahu Demir from Ladenburg Thalmann. Please go ahead. Operator00:43:16Your line is now open. Speaker 400:43:19Hello again. I just wanted to ask one more question regarding the odd outstanding debt. What is the current debt on the financial front? Speaker 100:43:30And I'm very happy to pass that question straight on to our CFO, but I can say it's an EIB loan. Speaker 300:43:39Yes. So basically, our debt structure is pretty simple. We have an EIB loan, which is of €7,000,000 and it has an expiry date of Q1, 2028. Speaker 400:43:57Got it. Okay. Thank you very much. Operator00:44:02Thank you. As there are no further questions, I would like to hand back to Christian Kantstrup for any closing remarks. Please go ahead. Speaker 100:44:13Yes. Thank you so much. And I just want to say thank you to all of you for all the relevant and good questions. And thank you for listening in. We are excited about what has happened over the past several months here and equally excited about what's to come for 2024. Speaker 100:44:33And we are looking forward to keeping you updated on that. So thank you so much for listening in.Read morePowered by