Good day, and thank you for standing by. Welcome to the Evaxion First Quarter 2025 Conference Call and Webcast. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be the question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Christian Kanstrup. CEO. Please go ahead.

Thank you so much, and good morning, and good afternoon, everyone. And a very warm welcome to this Evaxion business update call on the back of our Q1 2025 results. I'm Christian Kanstrup, CEO of Evaxion. With me today, I have, as usual, Birgitte Rono, our Chief Science Officer; Thomas Schmidt, Chief Financial Officer; and Mads Kronborg, our VP of Investor Relations and Communications. And for the agenda today, I will do the introduction, Brigitte, she will be doing the R&D update. Thomas will take you through the numbers, and I will end up concluding before we again, as usual, will jump into the Q&A. And before we get going, I will direct your attention to this slide. We will be talking about forward-looking statements. And as always, when you talk about the future that is uncertain. Hence, I direct your attention to the slide here. But with that, let's go, and let's look at the introduction. I think it's fair to say that we have had a super busy couple of months since the last business update. We have seen a strong progress across all parts of the business and are continuing to execute well. If we first look at business development, very pleased to say that the partnership with Merck is on track towards potential option exercise in the second half of the year. Needless to say, this is a key milestone for us if Merck exercises the options to both compounds in the option and licensing agreement, we will be in time to receive $10 million. Hence, a very important milestone, and I am pleased to see that we are tracking towards the decision point in the second half of the year. Also super pleased to see that our business development pipeline remains solid, and it supports…

Thank you, Christian. So we have a very broad R&D pipeline of AI immunology defined vaccines, spanning two key disease areas, cancer and infectious diseases. So today, I'll walk you through some of the latest progress in these key R&D programs. I'll start with EVX-01, our personalized peptide-based cancer vaccine currently in Phase 2. And then I will also touch on our advancement in our precision cancer vaccine program targeting this novel class of tumor antigens that are shared across patients. And then lastly, I will present our progress in expanding our infectious disease vaccine pipeline. So EVX-01, as mentioned, is currently in Phase 2, and it's being developed as a first-line treatment for advanced melanoma. The EVX-01 vaccine includes multiple patient-specific vaccine targets, so-called new antigens that we have identified using our AI immunology platform, by looking into the patient's tumor mutational profile and also feeding the immune response or the immune system of the patients. It's being administered in combination with immune checkpoint inhibitors with the goal of enhancing clinical efficacy. And as Christian mentioned, we presented biomarker and T cell immune data at the annual meeting in the American Association of Cancer Research. And at this meeting, we reported that EVX-01 induced a specific immune response in other patients assist so far and that 80% of the vaccine target triggered a specific immune response. And that is a frequency that is substantially higher than what has been reported for other similar vaccine candidates. Furthermore, immunizations increased and maintained the broadness of the vaccine-induced T cell responses. And with these data, we are tracking towards the two-year clinical data that we will report in the second half of this year. So building on these positive data and to further explore the durability of both the immune response and…

Thank you so much, Birgitte. I think it's fair to say no doubt that AI immunology really holds the potential for developing truly novel precision medicines, and it's great to see the progress in the pipeline. Let's turn to some progress in numbers and hand over to Thomas to take us through the Q1 results, please?

Yes. Thank you, Christian. So moving into the financials from the Q1 2025. Let me start with the key highlights that we had and have seen in the Q1. First and foremost, our cash position, we have significantly improved in the first quarter due to our capital market activities in Q1 and mainly even in January. So we have a cash position of $17.8 million, up from $6 million by the end of the year 2024. And with our operational cash burn, which we estimate of $14 million for the year. This also means that we have a cash runway until mid-2026, which really also means it's past potential exercise of options from MSD and also the EVX-01 two year clinical data readout. In Q1, we've seen less spending if we compare it to Q1 2024 as some of our -- most of our projects have higher spending planned in the upcoming quarters. Our equity has certainly also benefited from -- and strengthen benefited from our capital market activities. So end of Q1, we have total equity of $10.3 million, which is again a significant strengthening versus the end of 2024. If I dig a little bit further into the profit and loss statement of Q1, we have recorded a operating loss of $3.9 million, which should be compared to $4.4 million last year. Again, the overall lower operating expenses in Q1 is really the result of these. But we do expect that the project cost will pick up an increase in the coming quarters, fully aligned with our planning. As mentioned also already similar cash burn we expect this year as we had last year, so approximately $14 million. And also important to point out here that, that does not include any potential income from business development deals. So…

Thank you so much, Thomas, for taking us through the numbers. And let me just conclude before opening up the floor for Q&A. I do hope that you agree with me from the presentation here that we are maintaining the strong execution momentum Also, our financial position will significantly increase in cash and equity has been clearly moving in the right direction. Important is that we are tracking towards several potential value catalysts coming up in the second half of the year, which is derived from our clear strategy with a strong focus on value realization through our multi-partner approach. Also when talking about cash, our runway into mid-2026, is beyond both the two-year readout on 90 days of warrant and the potential option exercise from Merck, which would bring us an additional $10 million if both options are exercised for EVX-B2 and B3 which in turn would give us cash into 2027. So with that, I would like to open the floor for Q&A.

Thank you. [Operator Instructions] And it comes the line of Thomas Flaten from Lake Street Capital Markets. Your line is open. Please ask your question.

Hey, good morning. Good afternoon. Thanks for taking the questions. A few for beginning here. In the two-year EVX-01 data, was there a meaningful bias between CD4 and CD8 positive T cells?

We mainly see CD4 T cells. So in all the patients, we have all the samples from the patients we have analyzed so far, we have CD4 T cells. We also see CD8 in approximately half of the patients. And I think this virus is mainly driven by the fact that EVX-01 is a peptide-based vaccine. And we know that the way that the immune system is taking up these peptides and presenting them that directs a strong T cell response.

Excellent. That's very helpful. Thank you. And then on the lead ERV candidate that you have, is it the intention that, that will be a ERV hotspot vaccine only? Or will you combine that with personalized cancer neoantigens.

So the idea with this precision concept is to do an of-the-shelf vaccine. So we basically are able to design a vaccine that has what we call broad coverage, meaning that patients with different immune system and also expression profiles of these tumor antigens would benefit from receiving this type of therapy. So it is a precision-based vaccine, and we will at least not in the beginning, combine it with any other types of vaccines, including personalized approaches.

Understood. And then 1 final one for me. There was news last week out of the UK that they were going to repurpose a meningitis vaccine for gonorrhea. It looks like it provides limited protection. I was just curious if you had any thoughts on that or what may be your partners at Merck might have said about that rollout?

Before Birgitte speaks to the scientific content, then I can just say, Thomas, I mean, of course, this is just shows the level of desperation for having some effective therapy for preventive therapy for gonorrhea. Looking at the numbers that also was disclosed for the number of cases in the UK. It's a pretty significant increase. So clear that something needs to be done. And of course, this gives us a lot of comfort in regards to the commercial potential for EVX-B2 and then Birgitte, you can speak to the scientific rationale which of course is there, but --

Scientific rationale is there, it's also been known for a while that there is cross protection to gonorrhea, but it's far from complete, meaning that there is definitely a need for more precision vaccine that would give a broader protection. Yes, we have not discussed it with our collaborators indeed.

Got it. Thanks for taking the questions.

Thank you. [Operator Instructions] Speakers, there are no further questions for today. I would now like to hand the conference over to your speaker, Christian Kanstrup, for any closing remarks.

And I would just like to say thank you so much to everyone for listening in to our Q1 business update call. We are looking very much forward to the continued execution upon our strategy and will, of course, keep you all informed when relevant news unfolds and are looking forward to staying in touch with all of you. So thank you so much to all of you for taking the time for listening in and wish you all a good day.

This concludes today's conference call. Thank you for participating. You may now disconnect. Have a nice day.