Evaxion A/S Q2 2025 Earnings Call Transcript

Quartr
Provided by Quartr
August 14, 2025

Key Takeaways

  • Positive Sentiment: On track with the MSD partnership and expected to reach a potential option exercise decision in 2025.
  • Positive Sentiment: EVX-one Phase II two-year clinical efficacy data accepted for an oral presentation at ESMO 2025, with a three-year monotherapy extension now underway.
  • Positive Sentiment: Secured a grant from the Gates Foundation to develop an AI-designed polio vaccine, advancing platform validation without additional cost or risk.
  • Positive Sentiment: Cash runway extended to mid-2026, boosted by conversion of €3.5 million EIB loan into equity—adding $4.1 million and simplifying the balance sheet.
  • Neutral Sentiment: Expanded infectious disease pipeline with EVX B4 targeting Group A streptococcus, now in computational antigen identification and preclinical testing.
AI Generated. May Contain Errors.
Earnings Conference Call
Evaxion A/S Q2 2025
00:00 / 00:00

There are 5 speakers on the call.

Operator

Hello, and welcome to Evaxion's Second Quarter twenty twenty five Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. To ask the questions on the session, you will need to press 11 on your telephone. You will then hear an automated message advising your hand is raised.

Operator

To withdraw your question, please press star 1 again. I would now like to turn the conference over to Birgitte Runa, Interim CEO and CSO. You may begin.

Speaker 1

Thank you, Fabet. So, first and foremost, welcome to our Q2 twenty twenty five business update and financial results. I am Brigitte Roeneck, Chief Scientific Officer and Interim CEO of Evaction, and with me today I have Thomas Schmidt, Chief Financial Officer, now permanent CFO as of August 1, and Mels Krumborg, VP of IR and Communications. Today I will start with a short introduction followed by an R and D update, and then Thomas will present our Q2 financial results. And lastly, we are, of course, as always, open for questions.

Speaker 1

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 2025. Our business development pipeline remains solid and supports FY target. However, we do see that the challenging financial markets and increased regulatory uncertainty is impacting deal execution in general. Key R and D events and progress include EVX-one two year clinical efficacy data accepted for an oral presentation at the ESMO Congress in 2025 and treatment in the main part of the EVX-one Phase two trial is completed and patients have been recruited for the one year extension phase.

Speaker 1

We have also expanded our R and D pipeline with EVX004 and we'll 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 twenty twenty six, and we have converted our loan from the European Investment Bank to equity with an immediate increase in equity with $4,100,000 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 '5. If we take a closer look at our R and D pipeline and recent progress, we have a very broad R and D pipeline of AI immunology designed vaccine candidates spanning across two key disease areas, cancer and infectious diseases. And today, I'll walk you through some of our latest progress in key R and D programs.

Speaker 1

I'll start with our lead acid EVX-one, our personalized peptide based cancer vaccine currently in Phase two clinical development, and then I would also, as mentioned before, point your attention to our recently added pipeline program, PvXD4, a discovery program with the objective of developing a preventive vaccine against Group A streptococcus, and lastly, I'll present our progress in our CV program that is EVX V1. So, to EVX-one. EVX-one 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 two year data from the EVX-one Phase two trial will be presented at the European Society of Medical Oncology, also called ESMO, Congress in October. And the ESMO Congress is one of the most important and prestigious medical oncology conferences in the world, and we are very much looking forward to this as it gives us a great opportunity to interact with a global audience, including potential partners.

Speaker 1

And to this end, we are currently finalizing the two 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-one Phase II study, allowing us to obtain three year clinical outcome data. During this extension phase, EVX-one will be administered as a monotherapy, allowing us better to understand the vaccine's standalone 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 partner to understand this path.

Speaker 1

The strategy for the asset remains 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 their 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 and D pipeline with the addition of the EVXB4 program, and this program aims at developing a preventive vaccine against group A streptococcus, also called GAS, and development and testing of a 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.

Speaker 1

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 D4 we are hopefully able to offer such a solution. Lastly, I will briefly touch upon our EVX D1 program, and in this program we are developing a multi component vaccine for the prevention of CMV infections. We are in early preclinical development heading towards lead antigen selection in the 2025.

Speaker 1

We believe that an efficacious vaccine should contain both AB 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 injury. 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 essentials for viral entry that demonstrates superior ability to neutralize the virus.

Speaker 1

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 vaccines 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.

Speaker 2

Yes, thank you, Pikete, 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 a debt settlement agreement with the European Investment Bank where they converted €3,500,000 of the total €7,000,000 loan, and that was converted into equity via a purchase of ordinary Evaction shares. Our Evaction 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 $4,100,000 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.

Speaker 2

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 June $14,700,000 and with an operating cash burn that we still expect to be around $14,000,000 That also means we have cash in hand to fund operations until mid twenty twenty six. And important to note that takes us past the potential auction exercise by MSD and also past our two year data readout on our EVX-one study. Overall, our overall spend was reduced in Q2 twenty twenty five compared to same period last year, which mainly reflects project timing.

Speaker 2

We still expect for the full year to be at a similar level versus last year from a spending perspective also. Total equity June of $6,200,000 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 have the agreement registered with the European Investment Bank. Our Q2 profit and loss statement shows an operating loss of $4,300,000 which again compares to $4,600,000 in the same period last year. R and D project costs are expected to increase in the second half year, so in the two coming quarters, while we still expect operating expenses in line with twenty twenty four.

Speaker 2

This also means that we expect, as mentioned already, the operational cash burn of approximately $14,000,000 for the full year 2025. Our net financial expenses of $4,700,000 in the Q2, sorry, compared to 1,800,000.0 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 in 2024, while this year it comes from our January. So two independent and different derivative liability. Our net loss for the quarter of 4,800,000.0 compared to a net loss of 6,200,000.0 same period last year, and the main difference is exactly the difference in net financial expenses.

Speaker 2

So, that's the driver behind that difference. Turning to the balance sheet. Our equity of 6,200,000.0 U. S. Dollar, it certainly further will be strengthened in July or has been strengthened in July as we have booked the conversion into equity from the EIB.

Speaker 2

A derivative liability from the public offering, as mentioned in January 2025, net impacts our equity of 400,000.0 US dollar as of June. Cash at hand were 14,700,000.0 And again, really important to note that this gives us a cash runway until mid-twenty twenty six. So, passed our potential MSD option exercise and passed our EVX one two year data, but also importantly, the cash runway projections into mid-twenty twenty six does not yet include the potential MSD exercise or any new business development deals, so both will in that case further extend our patch runway. And with that, I hand it back to Birgitte for some closing remarks.

Speaker 1

Thank you, Thomas. So, lastly, as a conclusion 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 hand until mid-twenty twenty six, and that takes us, as Thomas also explains, beyond the EVX-one two 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.

Operator

Thank you. Ladies and gentlemen, as a reminder to ask a question, Our first question comes from the line of Thomas Flaten with Lake Street Capital Markets. Line is open.

Speaker 3

Morning or good afternoon. I appreciate you taking the questions. Brigitte, 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.

Speaker 1

Yeah, 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 and D collaboration, and there's been a lot of very exciting data generated under this collaboration, and we are currently, according to the plan, timelines are kept, and we are heading towards the conclusion here in the 2025. For B2, this is more a type of, I would say, evaluation collaboration. So MSG has been looking into our data and been conducting some studies on their side. Again, we are on track in terms of timelines and also, yeah, heading towards this conclusion in the 2025.

Speaker 1

So all in all, it looks very promising and we are progressing according to the plan.

Speaker 3

Got it. I appreciate that. And then one final question. If you look at the business development conversations you're having, you know, are they primarily on the infectious disease side? Is there some oncology interest?

Speaker 3

Can you maybe just give us a sense of what those discussions look like?

Speaker 1

Yeah, no, it's across the R and D pipeline and assets across the two 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. But we remain optimistic and do see also new dialogues starting.

Speaker 2

Got it. I appreciate

Speaker 3

you taking the questions. Thank you.

Operator

Thank you. Please stand by for our next question. Our next question comes from the line of Charles Wallace with H. C. Wainwright.

Operator

Your line is open.

Speaker 4

Hi, thanks for taking my question. This is Charles on for RK. I had a question about the data that ESMO coming up. So how will the two year data, like the clinical outcomes compared to the one year data that was presented? And how many of the patients from year one will be seen in the two year data?

Speaker 4

Then also with the extension to the third year, how many patients will you enroll additionally? Thank you.

Speaker 1

Yeah. Hi, Charles. Thank you for those questions. So we have not yet disclosed the two year data for EVX-one, so you have to be a bit patient here. We have, of course, since our last update of the clinical data, the one year data gathered additional information and scans, etcetera, of all the patients.

Speaker 1

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 are now have consented to participate in this additional year. They will receive two doses of EVX-one and without concomitant pembrolizumab treatment. So this allows us to look further into the mode of action of EVX-one without having this background of the checkpoint inhibitor. We have not yet said a lot about how many patients, etcetera, because there's still, yeah, we will come back with more information on this.

Speaker 4

Perfect. Thank you for taking my questions.

Operator

Thank you. I'm showing no further questions in the queue. I would now like to turn the call back over to Brigitte for closing remarks.

Speaker 1

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.

Speaker 2

Thank you.

Operator

Ladies and gentlemen, that concludes today's conference call. You may now disconnect.

Powered by Quartr