Evaxion Biotech A/S (NASDAQ:EVAX) Q2 2025 Earnings Call Transcript

Evaxion Biotech A/S (NASDAQ:EVAX) Q2 2025 Earnings Call Transcript August 19, 2025

Operator: Hello, and welcome to Evaxion’s Second Quarter 2025 Conference Call. [Operator Instructions] I would now like to turn the conference over to Birgitte Rono, Interim CEO and CSO. You may begin.

Birgitte Rono: Thank you for that. So first and foremost, welcome to our Q2 2025 business update and financial results. I am Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. And with me today, I have Thomas Schmidt, Chief Financial Officer, now permanent CFO as of August 1; and Mads Kronborg, VP of IR and Communications. Today, I will start with a short introduction, followed by an R&D update, and then Thomas will present our Q2 financial results. And lastly, we are, of course, as always, open for questions. So before we begin, please note that today’s presentation contains forward-looking statements based on current expectations and actual results may differ from this. So since last quarter, we have made significant achievements and with the partnership with MSD, we are on track towards potential option exercise in the second half of 2025.

Our business development pipeline remains solid and supports the FY target. However, we do see that the challenging financial markets and increased regulatory uncertainty is impacting deal execution in general. Key R&D events and progress include EVX-01 2-year clinical efficacy data accepted for an oral presentation at the ESMO Congress in 2025 and treatment in the main part of the EVX-01 Phase II trial is completed and patients have been recruited for the 1-year extension phase. We have also expanded our R&D pipeline with EVX-B4 and we will get back to the details around this. Further, we have received a grant from the Gates Foundation, allowing for risk and cost-free application of the platform in yet another disease, polio. On the financial side, we have cash at hand until mid-2026 and we have converted our loan from the European Investment Bank to equity with an immediate increase in equity with USD 4.1 million.

Since last quarter, we have achieved an additional milestone with the initiation of the EVX-B4 program and we are well on track with the many exciting milestones coming up in the second half of ’25. If we take a closer look at our R&D pipeline and recent progress, we have a very broad R&D pipeline of AI-Immunology designed vaccine candidates, spanning across 2 key disease areas, cancer and infectious diseases. And today, I’ll walk you through some of our latest progress in key R&D programs. I’ll start with our lead asset, EVX-01, or personalized peptide-based cancer vaccine currently in Phase II clinical development. And then I would also, as mentioned before, point your attention to our recently added pipeline program, EVX-B4, a discovery program with the objective of developing a preventive vaccine against Group A Streptococcus.

And lastly, I’ll present our progress in our [ CB ] program that is EVX-V1. So back to EVX-01. EVX-01 is, as mentioned, currently in Phase II and is being developed as a first-line treatment for advanced melanoma. As I mentioned earlier, our upcoming 2-year data from the EVX-01 Phase II trial will be presented at the European Society for Medical Oncology, also called ESMO Congress in October. And the ESMO Congress is one of the most important and prestigious medical oncology congresses in the world. And we are very much looking forward to this as it gives us a great opportunity to interact with the global audience, including potential partners. And to this end, we are currently finalizing the 2-year clinical outcome data for preparing it for the ESMO presentation and partner discussions.

And as we talked about earlier, we have extended the EVX-01 Phase II study, allowing us to obtain 3-year clinical outcome data. During this extension phase, EVX-01 will be administered as a monotherapy, allowing us better to understand the vaccine’s stand-alone effect. The extension involves minimal additional costs as clinical trials remain active and vaccine production is already complete. Furthermore, we are planning to seek advice from FDA around the path to registration for this compound as we believe that this is important for any potential partners to understand this path. The strategy for the assets remain unchanged, and we are actively seeking partners that can take the compound through the last steps of clinical development towards registration.

Yes. Another key recent achievement is the grant we received from the Gates Foundation. And in this collaboration, we are applying AI-Immunology to design a subunit vaccine against polio, and the project is progressing according to plan and in close dialogue with the Gates Foundation and the Polio Program Officer. So this initial grant could potentially lead to further projects and plans with the Gates Foundation or any other partner. As we saw that the announcement of the grant gave or generated significant attention to our platform and pipeline. Further, we are making strong progress in our infectious disease vaccine pipeline. And as mentioned, in June, we announced the expansion of the infectious disease R&D pipeline with the addition of the EVX-B4 program.

And this program aims at developing a preventive vaccine against Group A Streptococcus, also called GAS. And development and testing of potential GAS vaccine has been traced back to 1923, yet no vaccine exists today. So we have conducted initial computational analysis demonstrated that AI- Immunology can identify novel vaccine targets to combat the pathogen. We have ongoing and future planned activities that include identification and testing of novel antigens for immunogenicity, functionality and protection in mouse models and in vitro assays. So GAS infections can cause a broad spectrum of health issues, including severe invasive infections and also the development of immune-mediated life-threatening conditions. There is an increase in antibiotic resistance and therefore a great need for finding novel treatment solutions.

And with EVX-B4, we are hopefully able to offer such a solution. Lastly, I will briefly touch on our EVX-V1 program. And in this program, we are developing a multicomponent vaccine for the prevention of CMV infections. We are in early preclinical development heading towards lead antigen selection in the second half of 2025. We believe that an efficacious vaccine should contain both a B and T cell antigens and also glycoproteins that are known to be essential for viral entry. Despite many years of focus, no vaccine is approved for CMV, but with AI-Immunology, we believe that we can develop an efficacious vaccine that targets the virus from multiple angles. This multi-target approach stands out from traditional methods that have been focused on a limited set of glycoproteins involved in viral entry.

Combating the virus from numerous angles is expected to enhance the efficacy of future vaccines. And with our proprietary platform, AI-Immunology, we are uniquely positioned to optimize already no antigens and further to identify novel B and T cell targets. And to give an initial insight into the data in this program, we have designed a proprietary glycoprotein B antigen, and that is one of the glycoproteins essential for viral entry that demonstrates superior ability to neutralize the virus. Further, we are currently pursuing top ranked B-cell antigens identified with AI-Immunology and initial data demonstrate induction of the potent tumor or antibody immune response in immunized animals. Several T cell epitope vaccine designs targeting multiple genes in the viral life cycle have been completed and they all induce a strong cellular immune response.

So in summary, we do see significant progress across our pipeline in both our Oncology and Infectious Disease programs and we are well on track for our next milestones. And we look forward to updating you as our programs continue to advance. So with that, I will give the word to Thomas to present the financial results.

Thomas Frederik Schmidt: Yes. Thank you, Birgitte. And I will now, of course, go through the financial highlights, but we’ll start, first and foremost, with a summary of the agreement that we have made with the European Investment Bank that really fundamentally helps our capital structure. So on July 11, we finalized the debt settlement agreement with the European Investment Bank where they converted EUR 3.5 million of the total EUR 7 million loan, and that was converted into equity via a purchase of ordinary Evaxion shares. Our Evaxion shares and the purchase price was $4.87 per ADS, representing 89% premium versus the closing stock exchange on July 11. That immediately also in July then increased our equity by $4.1 million and also then, of course, both simplified our balance sheet and certainly reduced our overall liabilities.

Furthermore, and also looking forward, it improves our cash flow and certainly also the repayment of course that we need to do at the end of the loan agreement in 2028. So all in all, a very good agreement that we have reached with the European Investment Bank. And as mentioned, as the agreement was done in July, it is, of course, not included in our Q2 financials but will eventually be once we get into Q3. Q2 financial highlights. First and foremost, our cash position is, at the end of June, $14.7 million. And with an operating cash burn that we still expect to be around $14 million. That also means we have cash in hand to fund operations until mid 2026. And important to note, that takes us past the potential option exercise by the MSD and also passed our 2-year data readout on our EVX-01 study.

Our overall spend was reduced in Q2 2025 compared to same period last year, which mainly reflects project timing. We still expect for the full year to be at a similar level versus last year from a spending perspective also. Total equity end of June of $6.2 million obviously strengthened compared to end of last year due to the capital market activities we’ve done in the first half of the year. And again, this will further be strengthened in July as we — the agreement registered with the European Investment Bank. Our Q2 profit and loss statement shows an operating loss of $4.3 million, which again compares to $4.6 million in the same period last year. R&D project costs are expected to increase in the second half year, so in the 2 coming quarters, while we still expect operating expenses in line with 2024.

This also means that we expect, as mentioned already, the operational cash burn of approximately $14 million for the full year 2025. Our net financial expenses of $0.7 million in the Q2 compared to $1.8 million net financial expenses in Q2 last year and in both years driven by reassessment of our derivative liability. Important to note is that the derivative liability in 2024 came from the February public offering in 2024, while this year, it comes from our January public offering. So 2 independent and different derivative liability. Our net loss for the quarter of $4.8 million compared to a net loss of $6.2 million same period last year. And the main difference is exactly the difference in net financial expenses. So that’s the driver behind that difference.

Turning to the balance sheet. Our equity of USD 6.2 million, certainly further will be strengthened in July or has been strengthened in July as we have booked the conversion into equity from the EIB. The derivative liability from the public offering, as mentioned in January 2025, net impacts our equity of USD 0.4 million as of end of June. Cash at hand was $14.7 million. And again, really important to notice a note that this gives us a cash runway until mid-2026. So both past our potential MSD option exercise and past our EVX-01 2-year data. But also importantly, the cash runway projection into mid-2026 does not yet include the potential MSD expertise or any new business development deals. So both will net case further extend our cash runway.

And with that, I hand it back to Birgitte for some closing remarks.

Birgitte Rono: Thank you, Thomas. So lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum, and we are tracking towards several potential value catalysts. Business development remains a key priority and multiple parallel partnership discussions are currently ongoing. And as Thomas mentioned, we have cash at the hand until this 2026. And that takes us, as Thomas also explains beyond the EVX-01 2-year data and the potential MSD option exercise. And with that, I would like to thank you for your time and your attention, and we’ll be happy to answer any questions.

Q&A Session

Operator: [Operator Instructions] Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets.

Thomas Flaten: Birgitte, I was curious if you could maybe detail for us what remaining steps are there in the process for Merck to make a decision on whether or not they want to option either or both of the programs.

Birgitte Rono: Yes. Thank you for that question. So we have been running one of the collaborations, the B3 since September 2023. So we entered into this R&D collaboration. And there’s been a lot of very exciting data generated under this collaboration. And we are currently — according to the plan time lines are kept, and we are heading towards the conclusion here in the second half of 2025. For B2, this is more a type of, I would say, evaluation collaboration. So MSD have been looking into our data and been conducting some studies on their side. Again, we are on track in terms of time lines and also, yes, heading towards this conclusion in the second half of 2025. So all in all, it looks very promising, and we are progressing according to the plan.

Thomas Flaten: Got it. I appreciate that. And then one final question. If you look at the business development conversations you’re having, are they primarily on the Infectious Disease side? Is there some Oncology interest? Can you maybe just give us a sense of what those discussions look like?

Birgitte Rono: Yes. No. It’s across the R&D pipeline and assets across the 2 therapy areas and also centered around what we call target discovery collaboration, so where we apply AI-Immunology and find novel targets for a certain pathogen. So it’s a mixed picture at the moment, but definitely dialogues across some are more mature than others. And I think that’s just the name of the game. And it’s, of course — I know there’s a lot of curiosity around this. But as you know, we cannot say a lot about this until there is a signed contract. So — but we remain optimistic and do see also new dialogues starting.

Operator: Our next question comes from the line of [ Charles Wallace ] at H.C. Wainright.

Unidentified Analyst: This is Charles on for RK. I had a question about the data at ESMO coming up. So how will the 2-year data, like the clinical outcomes compared to the 1-year data that was presented, and how many of the patients from year 1 will be seen in the 2-year data? And then also, with the extension to the third year, how many patients will you enroll additionally?

Birgitte Rono: Yes. Charles, thank you for those questions. So we have not yet disclosed the 2-year data for EVX-01. So you have to be a bit patient here. We have, of course, since our last update of the clinical data, the 1-year data gathered additional information and scans, et cetera, of all the patients. We still have 18 — no, sorry, 11 patients active in the trial. So a lot of the patients are faring extremely well. So more to come on this. For the extension phase, it’s a subset of the patients that now have consented to participate in this additional year. They will receive 2 doses of EVX-01 and without concomitant pembrolizumab treatment. So this allows us to look further into the mode of action of EVX-01 without having this background of the checkpoint inhibitor. We have not yet said a lot about how many patients, et cetera, because there’s still — yes, we will come back with more information on this.

Operator: [Operator Instructions] I’m showing no further questions in the queue. I would now like to turn the call back over to Birgitte for closing remarks.

Birgitte Rono: Thank you for that. So finally, I would just like to say thank you for all of you participating in this business update and financial results. And we are, of course, as always, looking forward to update you on the further progress. Thank you.

Thomas Frederik Schmidt: Thank you.

Operator: Ladies and gentlemen, that concludes today’s conference call. You may now disconnect.