Evaxion A/S

Good day and thank you for standing by. Welcome to the Evaction Business Update conference call for year 2023. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 1 again. Please be advised that today's conference call is being recorded. I would now like to hand the conference over to your speaker today, Christian Kanstrup. Please go ahead.

Hello, everyone, and a very warm welcome to this Evaction Business Update conference call on the back of our full year 2023 results. I'm Christian Kanstrup. I'm the CEO of Evaction. With me today, I have Birgitte Rønne, our Chief Scientific Officer. I have Jesper Nygaard Nissen, our Chief Operating Officer and Chief Financial Officer. What 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&D and business update. And Jesper will be covering the 2023 financial results after a few conclusive remarks. by me, we will be heading in to the Q&A session. So looking forward to an interactive session. Before 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. We have launched it and it's well anchored. And just to remind you, this is about a three-pronged business model. And I will 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 secured. We have MSD, GHI as our largest shareholder. Very pleased with that. We have also seen solid progress on our R&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 EVXB1 data. Across the business, we have been focusing on optimizing our cash burn, but important so, without compromising our long-term growth opportunities. That 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 evaction journey. Let me just give you a brief corporate update. I just want to recap a little bit on our strategy and our refined strategy. We have a three-pronged business model, which is based upon our AI Immunology platform. Important here is also that we are having a multi-partner approach to value realisation. 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 discovery, design and development of novel vaccines. Based upon this platform, we have the three-pronged business model to realize value. One is targets, one is pipeline, and one is responders. The target piece, that's around a multi-partner approach focusing around either single or multiple target discovery, design, and development agreements. And 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 one year phase two data for EVX01, which we expect in the third quarter. Finally, we have the responder prong, which is really about utilizing our core capabilities within data and predictive capabilities to develop responder models. And here we have the proof of principle for our checkpoint inhibitor model in the fourth quarter 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 we have seen here. In December 23, we closed a 5.3 million private placement. Here 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 million gross public offering. Also here, we had MSD GHI participating. And that now means that MSD GHI is the largest shareholder of Evaction with just below 15% ownership. In parallel with this, we have been intensifying our focus on value realization via partnering. We have the ambition to fund our 2024 operational cash fund of 14 million 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&D side of the business over the past months. Birgitte, will you take it from here?

Yes, thank you, Christian. So today I'm excited to give an update on the recent progress achieved in phone-specific R&D pipeline programs. So let's turn to slide nine. We have communicated initial encouraging data from our EVX01 personalized cancer vaccine phase two trial. We have increased our focus on developing a precision cancer vaccine with broad applicability For our EVXB1 Staph 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 EVXB3 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. Our pipeline includes several vaccine candidates at various stages of development, and that exemplifies our commitment to saving and improving lives with AI immunology. If we look at our EVX01 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-PD1 pembrolizumab, which is the standard of care for this indication. And then they're treated with our personalized EVXO1 vaccine at week 12. If we move to slide 12, we have monitored the ability of the EVXO1 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 five 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 EVX01, which we also observed in the phase one study. And the next significant milestone is one year clinical readout in Q3 this year. So 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. An upcoming milestone for this program is preclinical proof of concept in Q4. 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. So we and an undisclosed collaborator, we tested our vaccine antigens against Abilococcus 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 collaborators regarding the path forward. So, for our EVXO-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. So we have now concluded on the antigen discovery and design 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 MSG in the second half of 2024. 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.