Evaxion Biotech A/S (EVAX) Q3 2025 Earnings Report, Transcript and Summary

Hello, and welcome to the Evaxion Business Update and Third Quarter 2025 Financial Results. [Operator Instructions] Please be advised that today's conference is being recorded. I would now like to hand over to Birgitte Rono, Interim CEO and CSO. Please go ahead.

Thank you. Good morning and good afternoon, and thank you all for joining our Q3 2025 business update and financial results conference call. I'm Birgitte Rono, Chief Scientific Officer and Interim CEO of Evaxion. I'm joined today by Thomas Schmidt, Chief Financial Officer; and Mads Kronborg, Vice President of Investor Relations and Communications. I'll begin by walking through the agenda for today's presentation. I'll start with a brief introduction, followed by an R&D update, and then Thomas will present the Q3 financial results. And lastly, after a few conclusive remarks, we will open for questions. I'd like to remind everyone that today's presentation may contain forward-looking statements, and these are subject to risks and uncertainties, and actual results may differ materially. First and foremost, I'm pleased to welcome Dr. Helen Tayton-Martin as the new CEO of Evaxion effective November 24. So Dr. Tayton-Martin brings extensive biotech leadership, fundraising and partnership experience. Helen co-founded Adaptimmune and has held several senior executive roles in Adaptimmune. Helen holds a PhD in molecular immunology and MBA and with more than 30 years of experience in early research through project approval, Helen is an ideal candidate to lead the next stages of Evaxion strategy. This also means that I will return to my previous role as CSO and with Helen's transition from Director in the Board to CEO, Jens Bitsch will join the Board as an adviser and observer with the intention to seek election at the next AGM. Since the last business update, we have made several significant achievements. Historical in-licensing of EVX-B3 by MSD, providing significant cash and validation. The extension evaluation period or the evaluation period for EVX-B2 has been extended. We have several ongoing partnership discussions, though market uncertainty affects deal climate. We have presented two-year clinical efficacy data for EVX-01 at the ESMO Congress, and we have added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia to our pipeline. Further, we have expanded our AI-Immunology platform with an automated vaccine design module, improving quality and reducing vaccine design time. Lastly, we have strengthened our financial position, and we now have a cash runway extended to second half of 2027. And this is based on a USD 7.5 million option exercise fee received from MSD and an additional capital market funding sources, and Thomas will share detail around this. So, as mentioned, one of the main highlights of the quarter is the MSD transformative deal. So, in September 25, was a historical moment for a vaccine with MSD or Merck exercising their option on EVX-B3. So this was the first ever in-licensing of an AI discovered vaccine candidate by a major pharma company. And as mentioned, the $7.5 million exercise fee extends our cash runway significantly. The deal confirms our strategy of value creation through partnerships even with industry giants like MSD. It also validates our AI-Immunology and R&D pipeline and further ensures the development of EVX-B3 without cost for Evaxion. And not related to the EVX-B3 deal as such, the EVX-B2 evaluation period has been extended. So 2025 is shaping up to be a pivotal year for Evaxion. We've achieved several key milestones since the last business update. As mentioned, MSD exercised the option on EVX-B3. We presented two-year clinical outcome data from our EVX-01 Phase II study, and we have announced the addition of EVX-04 to our pipeline and EVX-04 is the lead candidate for our precision cancer vaccine. And looking ahead, we are expecting to provide further R&D and business development updates. So let's shift focus to our recent R&D and AI-Immunology progress. EVX-04 is our novel AI designed cancer vaccine candidate targeting nonconventional antigens from the dark genome, so-called endogenous retrovirus or ERVs. And these ERVs are specifically expressed in cancers of dormant in normal tissue, making them an attractive target for cancer vaccines. EVX-04 is a therapeutic cancer vaccine aiming to induce immune control in acute myeloid leukemia, where we know relapses remain a major challenge. The vaccine is based on our AI-Immunology platform, leveraging our discovery engine to identify multiple and optimal tumor-specific epitopes that matches the expression profile and also the immune characteristics in patients. And we have now designed the lead candidate and have conducted preclinical studies. Next steps include GMP manufacturing and additional IND-enabling studies to prepare for a first-in-human study. With the EVX-01 lead vaccine candidate selected, the program has been added to our pipeline. Further changes include the removal of the EVX-02 program as we do not have any active development currently ongoing on this program. The EVX-02 vaccine program serves as proof-of-concept for DNA delivery of neoantigen and has informed on the design of both EVX-03 and 04. Our lead program, EVX-01, a personalized cancer vaccine that includes multiple patient-specific targets, so-called neoantigens that we identify with our AI-Immunology platform from patient tumor material. EVX-01 is administered in combination with pembrolizumab, an immune checkpoint inhibitor to enhance the clinical efficacy. So, in October, we presented two-year clinical outcome data from our Phase II trial in an oral session at the ESMO Congress. And the results are highly encouraging and were received well by the scientific and medical community. So, at the congress, we reported a 75% objective overall response. We also saw that 11 out of 12 patients that responded had a sustained response at two years mark. We also saw a 34% conversion rate, meaning that patients with stable disease or a partial response deepened their response upon EVX-01 treatment. So we find the clinical outcome data very encouraging. And further, we believe that they compare favorably to historical pembro monotherapy data. Equally encouraging is the strong immunological activity of EVX-01, which is critical for long-term efficacy. So, in all patients treated with EVX-01, we saw a neoantigen-specific T cell response. Further, when assessing the individual neoantigen immune responses, we demonstrated that 81% of the vaccine neoantigens administered across patients were immunogenic. So this high hit rate provides strong evidence of the predictive power of our AI-Immunology platform. We also showed that the immune responses were sustained throughout the two-year trial period. Even after dosing after the dosing period ended, T cell activity remained high, indicating lasting immune memory. And durable T cell responses are essential for preventing relapses and in achieving long-term control of melanoma. So this reinforces the potential of EVX-01 as a personalized immunotherapy that not only drives tumor shrinkage in combination with standard of care, but also builds on a robust immune defense. As mentioned, our AI platform has been enhanced with a new automated vaccine design module, significantly reducing design time and also accelerating development time lines. It enables us to optimize vaccine candidates with high precision, both for new and approved vaccines. So, from data input to candidate generation, the process is now fully automated, ensuring optimal sequence and confirmation of vaccine targets. And as mentioned, the new module speeds up vaccine development while reducing costs compared to traditional methods. And further, it seamlessly connects with downstream processes supporting a smooth transition from design to production. And the design module has already been applied in some of our key R&D projects. One first example is the use of the module to identify and select regions of an antigen that can be expressed. So we noticed that the full length of a particular antigen could not be expressed due to solubility constraints. But when we applied the new module, we identified truncated variants of the antigens that then could be expressed, opening for preclinical evaluation of that antigen. Another example is of the application is that we can, with the module, predict most optimal sequences of a vaccine target based on a given antigen protein structure. And here, we have also been able to rescue a HER2 express protein that would require labor-intensive and trial and error design approaches to find expressible constructs. So with this new design module, it position us at the forefront of AI-driven vaccine innovation and further enable us to move fast from target discovery to final product candidate. So, in summary, we have seen significant progress across our R&D pipeline and AI platform, and we are on track for the next milestones. And we look forward to updating you as our programs continue to advance. So, with that, I would like to give the word to Thomas to present the financial results.

Yes. Thank you, Birgitte. I am happy to present the financial results for the quarter. And maybe let me just start with an overview of the achievements that we have done throughout the year up until now based on strong execution of our financial strategy. As we can see here on the slide also, throughout the year, we have made a number of activities with capital market activities with, of course, also the agreement that we did with the European Investment Bank of debt conversion plus also MSD out-licensing of the EVX-B3. So throughout the year and up until end of October, we have activities in the -- to the sound of USD 31.8 million, all which basically helps strengthening our equity and certainly also our runway, which is now extended into the second half of 2027. So really a good and strong achievement and following the financial strategy that we have laid out. If we zoom in on the third quarter and the highlights from the third quarter, we certainly have had a strong financial quarterly performance. As mentioned, the cash runway now has been extended into the second half of 2027. And we've also seen in the quarter the option exercised by Merck or MSD, which not only provides cash income now, but also has a future revenue income of potentially up to $592 million. We are well on track also in the third quarter on delivering on our financial targets for the full year. And throughout the quarter, we have also really solidified our equity through the European Investment Bank debt conversion and also through the MSD income. So really a good and strong quarter. If we look a little bit closer on the profit and loss element of it, clearly, the revenue from MSD drives the first -- drives the quarterly operational gain, the first of its kind for action -- but also importantly, our operating expenses, not only do we manage those well, but we actually also are slightly below last year and more or less at the same level as previous quarter. So also from earlier communications, we expect from a cash flow perspective to still hit around about the $14 million operating cash flow level. Net financials in the quarter is to the sound of $1.3 million, driven by the debt conversion that we did in July. The debt conversion in July with the EIB happened at an 89% share price premium at the market close of July 10. That premium has been recorded on the financial income for the quarter. And that then brings the income for the quarter to the USD 4.6 million. Turning to the balance sheet. We certainly, as mentioned already, have continued the strong execution that also has improved our equity. The equity now stands at the end of the quarter at USD 16.6 million. Included in the equity is a derivative liability with a net impact of $1.5 million. The derivative stems from our public offering in January and the investor warrants that we had from that date. However, in October, we have seen, as mentioned already, warrant exercises of $2.7 million, which means that this net impact of the derivative will be at a minimal value at the end of the year. So also a good outcome. It's also reduced our outstanding warrants by 1 million ADSs, and we now have a remaining outstanding warrants of 2.8 million. Also important to note is that our cash balance end of June is at a sound and solid USD 10.6 million and we'll see further cash income as we -- or cash flow in as we received in October, the revenue income from MSD and also the cash from the sales of shares due to the investor warrant exercise. And last but not least, the debt conversion -- debt to equity conversion with the European Investment Bank really has strengthened our balance sheet, has improved our cash flow as we move forward and has certainly also lowered our leverage. So really a great outcome from that event also. So a good solid quarter following along our financial strategy. And with that, I then hand it back to Birgitte.

Thank you, Thomas. So lastly, as conclusive remarks, I would like to highlight that we do have a strong operational momentum. We have achieved the majority of our 2025 milestones and are tracking towards several potential value catalysts. Business development remains a key priority and multiple parallel partnership discussions are currently ongoing. Cash runway is extended to second half of 2027. And with that, I would like to thank you for your time and attention, and we'll be happy to answer any questions. Please follow the operator's instructions. Thank you.

[Operator Instructions] First question comes from Soumit Roy at JonesTrading.

Congratulations on all the progress this quarter. A quick question on the EVX-01. What are -- if you can give us any color on the potential partnership deal, like what seems -- what is the key question that you're getting from a partner, they want to wait for a much longer-term data or any other key achievements you have to present for a successful deal?

Yes. Thank you for that question. So we just presented, as mentioned, the two-year clinical outcome data. And I would say that we have moved from questions around quality of data, how does your platform work to more how can we apply your technology within perhaps other types of cancer indications. So the data was received well, and we have been discussing it with key opinion leaders. We have also been discussing it with potential partners. And the strategy is that we will out-license it at the current development stage and then the partner can, of course, decide on potential next step. If we continue on the track we are currently with advanced melanoma, the next most likely step would be to conduct a larger randomized control arm study comparing the combination of EVX-01 plus standard of care to standard of care alone. So that's at least one option, but we also do see the potential of taking our technology and applying it in other disease or cancer indications where there is a high mutational burden, meaning that we can select high-quality neoantigens and formulate a vaccine that would benefit the patients. So multiple different discussions are ongoing and also different questions are coming our way. But generally, the questions are not about the quality of the data or the impact of the data, but more how can we move this forward together and find solutions for manufacturing and also for other indications.

Got it. One last question. Congrats on unveiling the EVX-04 in the AML program. If you can give us a slight understanding on the target or how is it -- is it expressed on AML stem cells, like CD33, CD123 have been tried and trying to understand what is the differentiation from this target.

Yes. No, this is a very good question. So the way that we have applied our AI-Immunology platform is that we look at genomic and transcriptomic data. And for this particular type of antigens, we mainly look at transcriptomic data. So the sequences that are being expressed as messenger RNA or RNA in general in the tumors. And then we have looked -- we started out by actually analyzing several different types of novel classes of antigens. And we realized that in certain indications and AML is one of them, there's a very high expression level of these endogenous retroviral sequences from the dark genome, meaning that we can across patients, find shared sequences and put them into a vaccine and thereby being able to support several patients with one single vaccine. So this is an off-the-shelf approach where we will be able to use the same vaccine across the different tumor profiles and also across the different immune characteristics of the patients. But we're still using AI-Immunology and our core technology to identify the most optimal antigens. Now it's just coming from the dark genome.

The next question comes from Nelson Cox at Lake Street Capital.

Nelson on for Thomas. Congrats on all the progress here this quarter. I'll maybe ask my two upfront, and apologies if I've kind of missed some of this, I had some technical issues. But a lot of updates here as of late. Maybe at a high level, can you please comment on just the overall breadth of partnering conversations you're having across your pipeline and how those have kind of evolved over the last year? And then when you look at the proportion of your business development conversations you're having today, can you kind of talk about how many are focused on target discovery versus the programs kind of already in your pipeline?

Thomas, thank you for that question. So we do have multiple dialogues ongoing. And I would say that they are across -- the interest is across our R&D pipeline, but also centered around our capabilities for identifying novel targets, so classical target discovery programs. There's interest in our oncology programs, and there's also interest in our infectious disease programs. So it's a little bit mixed, I would say, and some companies do have preferences in infectious disease. Some do have interest in both vaccine candidates that we have developed and in target discovery collaborations. So a little bit of mix and that confirms, I would say, our strategy to monetize on both our own in-house developed vaccine candidates, but also to enter into or target discovery collaborations. I cannot comment so much on exactly where we are as it's really difficult to speculate exactly on the timing of when these different dialogues would move into a real deal. But a lot of activities, and we can see that the interest is increasing when we have major data readouts as we have had in this last quarter with the EVX-01 Phase II data coming out.

[Operator Instructions] The next question comes from Swayampakula Ramakanth at H.C. Wainwright.

This is RK from H.C. Wainwright. So, certainly, there are very interesting developments going on at the company. So can we focus for a second on your automated design module, which is yet another interesting AI design -- drug design module that you have. So how should we think about this? Is this something that can help your internal designing -- I mean, designing of your internal molecules only? Or is this up for entering into partnerships? Or can you utilize this as a separate licensing situation where any of your partners could take that into their own computing systems and run on their own proprietary molecules. It looks like there's a lot of places where this thing could go. And what are your thoughts on that?

Yes, you're absolutely right. It can go in multiple directions. So, in the past, we have used AI immunology to identify novel vaccine targets. And then these targets have then been undergoing manual processing, ensuring that we could also express them and manufacture them. And this process has been labor intensive. So the ambition was to set up an automated process for this. And we have now been able to launch a new module where several different AI tools are being integrating, enabling us to go from target discovery to product candidate selection very fast. So that can, of course, be applied to our own programs, but we also do see an option of using this capability to support other companies in ensuring that what they select as their key antigens or in general, key targets that these antigens or targets can also be produced in a cost-effective way. So I do see multiple options for monetizing on this new module.

Okay. So, and then coming into the real world and talk about EVX-01 for more -- for another minute. At SITC, you're planning to present some additional data from the ongoing trial. What sort of data would come out from there? And how would it strengthen your narrative on EVX-01, not only for yourselves, but also for a potential partner, whether it is just on the drug or on the platform, just as you were talking about with -- when you're answering Soumit Roy?

So at ESMO, we presented the clinical outcome data, and we are still in the process of analyzing patient samples. So -- we have collected samples, blood samples before therapy during vaccination and then also as follow-up samples. And all of these samples from the patients are currently being assessed in our own labs. So, we do, of course, monitoring of the EVX-01 induced T cell responses, but we also do deeper phenotypic analysis. So some of this will go out at SITC. We have a poster presentation, but also at future conferences because we have not analyzed all the many samples that have been collected from the patients. So more to come, more deep dive into the immune profiles of the cells. collected from the patients. And then we also have the extension phase of the EVX-01 trial where six patients are now receiving EVX-01 as a monotherapy. So more data will come from this subset of patients.

Perfect. And then my last question is on the MSD relationship. And it's great to have the $7.5 million. But how much more -- do you still need to give any additional data for the second molecule? Or is it the Merck still has to complete their due diligence on that -- on the data that you've given them in terms of running confirmatory studies or data analysis for them to decide whether they want to spend the other $2.5 million?

Yes. So, for EVX-B2, MSD is currently evaluating the data that we have provided and further, they are in the process of generating some confirmatory analysis. And that was also why the evaluation term was extended. So we expect that they will come back with an answer in the -- or in the first half of next year. But the process is ongoing, and it's, of course, very exciting, and we would love to out-license EVX-B2 to MSD.

There are no further questions. So I shall hand back to you for final remarks.

Yes. And thank you for joining us today. And please do not hesitate to reach out should you have any additional questions. Thank you.

That concludes today's presentation. Thank you for participating. You may now disconnect. Speakers, please stand by.