Evaxion Biotech A/S Q3 FY2025 earnings call

• Helen Tayton-Martin joined as CEO effective November 24, bringing extensive biotech leadership, fundraising, and partnership experience. Birgitte Rono will return to CSO role. Jens Bitsch to join Board as adviser and observer. • MSD in-licensed EVX-B3, providing significant cash and validation. • EVX-B2 evaluation period extended. • Presented two-year clinical efficacy data for EVX-01 at ESMO Congress. • Added EVX-04, a novel therapeutic cancer vaccine for acute myeloid leukemia to pipeline. • Expanded AI-Immunology platform with automated vaccine design module. • Cash runway extended to second half of 2027 due to MSD option exercise fee and capital market funding.

No specific product segment financial performance details provided in the transcript.

• Expect further R&D and business development updates. • Cash runway extended to second half of 2027.

• Market uncertainty affecting deal climate. • Forward-looking statements subject to risks and uncertainties where actual results may differ materially.

Q: 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?

A: 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.

Q: 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.

A: 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.

Q: 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?

A: 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.

Q: 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?

A: 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.

Q: 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?

A: 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.

Q: 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?

A: 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.