Evaxion A/S (EVAX) Q2 2026 Earnings Call Transcript

I'm Helen Tatum-Martin, I'm the Chief Executive of Action, and we're delighted today to be presenting our Q2 Business Update. I'm joined today on the call by Birgitta Rona, our CSO and COO, who will provide an overview of our updates in our R&D pipeline and AI immunology platform. Then I'll hand over to Thomas Smith, who will talk through our Q2 financial results before we bring it back to conclusions and Q&A. So first, of course, we may make forward-looking statements, and the audience is advised to look at our recently filed SEC documents, and now I'll kick off the discussion. So really, Q2 has been marked by a series of achievements in our four core areas, or four core platforms for the company. First of all, just focusing on business development, as previously and ongoing through the course of this year, there are many discussions we are having with partners regarding the Evaction programs and pipelines. We've had a stream of very encouraging new data, which continues to come through and continuously validate the AI immunology platform, which really feeds into those various conversations. And we'll touch on some of those today. And in particular, in our R&D area, we have been very pleased to be accepted to present further updates on our EVX-01 program, our personalized neoantigen cancer vaccine in advanced melanoma patients. And obviously, it was a great day for the field yesterday to see the positive phase three results from the similar Moderna-Merc program in personalized cancer vaccine in melanoma produced. And so it will be great for us and the field to talk more about that as we head into ESMO and an update on our own data there. Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVXO3 and EVXO1 platform, actually, into a new program, which we call EVXO5 in glioblastoma, where we are further leveraging the herbs that we have been able to identify highly conserved antigens for glioblastoma, building on what we have done in our EVXO4 program using a similar approach to use AI immunology to find highly conserved antigens in AML. So we've presented new pre-clinical data on that earlier this year at the European Haematology Association annual conference, and we've also updated in our infectious disease portfolio on our EVX V1 CMV program too at the recent HSE, Herpes Sublex conference last month. More broadly on AI immunology, the platform itself, we were really delighted to see that recognised in the Galien UK award, a second Galien award we have had for the technology in the last 12 months. So very exciting to see that being recognised more broadly, more globally in terms of the value in AI immunology prediction for our programmes in infectious disease, oncology and autoimmune disease. And finally, in terms of the core of our updates. We have maintained a disciplined focus on our resource allocation, really strongly aligned to where we can build the most value from the platform. And with that discipline, we can confirm that our cash runway remains unchanged with cash at hand to fund our operations into the second half of 2027. And Thomas will talk more about that. So just a reminder before we jump into it, our pipeline consists of a number of programs in cancer and infectious disease at the current time. EVXO1 will be a focus for Bagheeda's presentation in a few moments, and obviously also including our EVXO4 and EVXO5 programs, which are focused on the conserved and off-the-shelf antigen vaccines. In infectious diseases, we have a number of preclinical programs there, and some of which are partnered, one with Merck, one with Afrogen, and data is continuing to build around the interest that we have on those programs from partners. So in terms of where we are, as we meet the halfway point of 2026, we have already met the first of our milestones in terms of updating on the EBX01 platform at AACR earlier this year with biomarker and immunogenicity preclinical data, alongside the clinical data from year two at Lesmo last year. We have mentioned already, and we will be updating on the three-year data from that program with efficacy results at ESMO in October. And in the rest of this course of this year, we will be talking more about the application of AI immunology in autoimmune disease, as well as planning for the regulatory filing of that EVXO4 program, the off-the-shelf program in AML. And finally, we will have an update on our Group A strep program with the design of preclinical validation of antigens in their EVXB4. And we continue to prosecute a partnership approach around these programs and platforms where we see value creation. So with that, I'll hand over to Nagita, who will talk you through our R&D and AI immunology update.

Thank you, Helen. So today I'll focus on our lead asset, EVXL1, so that our personalized new antigen cancer vaccine currently in place two in advanced melanoma. Then I'll present our new off-the-shelf EVEXO-5 vaccine program, demonstrating the scalability of our AI immunology platform into the hard-to-treat and deadly brain cancer glioblastoma. So lastly, I'll showcase how AI immunology identified T-cell epitopes are relevant in controlling CMV infections. So, as Helen mentioned, we'll present three-year EVX-01 phase two outcome data at the ESMO Congress in October, and this data includes evaluation of the vaccine's effect as a standalone and also in combination with anti-PD-1 treatment. The data will potentially give further insight into enhanced effect, treatment effects, and also the durability of EVX-01-induced immune responses, and collectively these data provide a more comprehensive assessment of the full potential of EVX-01 to strengthen the already strong clinical data page. So looking back at previously announced data from the EVX-01 phase two trials, we reported strong EVX-01 induced immune activation at the ASCR meeting in April. So we were able to show that 86% of the EVX-01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported for other similar vaccine candidates. Furthermore, we also showed that 86% of the immunogenic vaccine targets induced a de novo T-cell response, meaning that EVXL1 specifically triggers novel T-cell responses rather than amplifying existing responses. And this is very important as induction of de novo T4 responses has been linked to clinical benefit. And at the ESMO Congress last year we reported two-year outcome data including a 75 overall response rate, 25 complete responses, and 92 of the patients still being in response indicating durable clinical benefit. And importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. So over the last approximately 10 years, personalized new antigen vaccine has shown promise across several early phase clinical studies. And with the Moderna-America announcement yesterday, we can definitely say that the field is moving from promising experimental immunotherapy towards a clinically validated therapeutic modality with a clear and realistic path to regulatory approval. And these data are not just only a win for Moderna and Merck, but it's a win for the entire field as they boldly validate the personalized new antigen vaccine concept. So overall with our encouraging EVXO1 data and with the validation from Moderna and Merck, we believe that we are well positioned as we move forward towards further value creation. And so let's turn our focus to our off-the-shelf cancer vaccine programs. So in collaboration with Duke University we We are developing an off-the-shelf vaccine, EBXO5, for glioblastoma or GBM, targeting conserved antigens as announced earlier this week. So GBM is the most common and most aggressive primary malignant tumor, brain tumor, and despite surgery followed by chemoradiation, outcomes remain very poor with a median overall survival of approximately one year, underscoring a significant medical need. So our EVXO5 approach builds on the same novel and broadly applicable concept as EVXO4 as it is designed with AI immunology to target conserved tumor specific antigens derived from endogenous retrovirus elements or ERS which are part of the dark genome. The target selection process allows for a broad tumor coverage despite immune and tumor of antigen differences across patients. So we have applied AI immunology, so our AI powered target discovery approach and identified an optimal set of earth fragments based on cross patients relevance and immunogenic potential. And we have mined patient sequencing data identifying approximately 1.5 million ERP fragments and selected 16 of these as the fragments that will be included in the EVX-05 vaccine. So next steps include lead candidate selection and IND enabling activities prior to a first in human studies that is expected to be conducted in collaboration with the world leading GDM experts we are collaborating with at Duke University. So our other off-the-shelf cancer vaccine program, EVXO4, is also progressing well. So EVXO1 targets multiple conserved herbs in the case of this program identified in AML patient samples. So as Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVXO4 vaccine is expressed and secreted by human cells, enabling immune recognition and activation. So further we showed that the 16 herb targets included in the EVA-XL4 vaccine activates human immune cell across different HLA types and that these herb reactive immune cells can mediate targeted cell killing indicating not only immune recognition but also also relevant functional impact of these vaccine-induced immune cells. So collectively, these data highlights EVXO4's potentials as a new effective therapeutic cancer vaccines. And we look forward to reporting further data as the program progresses towards regulatory filing later this year. So another promising program presented at a scientific conference during the summer is our EVX V1 cytomegalovirus or CMV vaccine program. So in EVX V1, we are using AI immunology to design a known target, so optimizing them and also to identify previously unexplored vaccine targets. And at the International Herpes Virus Workshop in July, we presented new data demonstrating that Tiesel epitopes discovered with AI immunology have the potential to control acute infection, latency, and also reactivation in CMV infected mice. And this is a key finding as it complements previous results demonstrating the ability of both novel and optimized non-B cell antigens to reduce viral infection. And the data will guide antigen selection for a bodily protective CMV vaccine candidate and, as such, represent a very important step forward for the EDX v1 program. So having highlighted progress across our key R&D programs, let's now focus on our AI Immunology platform and the data validating its ability to generate high-quality product candidates. So AI immunology is clinically validated with positive outcome in three out of three oncology trials. Pre-clinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer, with our herb targeting vaccines, as well as in infectious diseases, with several candidates against bacterial and viral pathogens. And importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. And additionally, the novel earth-based cancer vaccine concept is used in both our off-the-shelf programs EVX-04 and EVX-05. So finally, AI Immunology supports multiple modalities including peptides, recombinant proteins, DNA and RNA platforms enabling both pipeline and partnering percentage so in conclusion we've demonstrated strong progress across our R&D pipeline and we look forward to providing updates as our programs progress so with that I'll hand over to Thomas who will present our quarterly financial results perfect thank you beginning and let me jump straight into the presentation of the financial results for the

second quarter of 2026. the main highlights to start with that for the quarter is that we have indeed continued our disciplined resource allocation throughout our strategy direction of course and certainly also very much aligned to the priorities around the value drivers that we have defined and also communicated earlier for this year so full alignment and full progress on those elements we are certainly also on track to deliver according to our financial plan which both shows in the q2 results but certainly also confirmed from the cash position that we do have. And the cash position we can reconfirm, as mentioned by Helen already, that we have a cash runway that runs into the second half of 2027. So reconfirmed and maintained from earlier communication also. Looking a little bit closer to our profit and loss statement for the quarter, Overall, we see a slightly reduced operating expenses, mainly driven from our general and administration costs or the GNA costs, where we have significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses do show a slight increase versus last year, but it's fully aligned with all the progress that Birgitta just mentioned on EVX01, EVX04, EVX05. And again, also those programs are confirmed within our cash runway until the half year to 2027. we reported a net loss for the period of 3.7 million again as mentioned already on plan and following the execution that we've set for this year balance sheet we have a cash position at the end of the quarter of 14 million we are we are again reconfirming our cash runway and the equity that we also have reflects the result for the first six months meaning that we are at 9.5 million at the end of the second quarter reflecting that versus last year of the net result so all in all a good financial performance aligned with the expectation and certainly aligned with the progress of our platform and portfolio and with that i hand it back to helen for some concluding remarks thanks thomas and thanks begita um so in conclusion i would want to emphasize that we've seen some really good

operational momentum on our set milestones and actually with a new program emerging with EVX 05 from all of our activities, but still maintaining our cash run way into the second half of 2027. We're really excited by the stream of new data that we've continued to generate with the team that continues to validate that AI immunology can deliver products, real meaningful products for future development. And that is the core underneath all of our ongoing business development discussions as we continue to process which programs that we bring forward and with which partners.

So with that, we are very happy to take questions and thank you for your attention.

Thank you. To ask a question, you will need to press star one and one on your telephone and wait for your name to be announced. To withdraw your question, please press star one and one again. One moment for our first question. And this question comes from Thomas Flaten from Lake Street Capital Markets. Please go ahead.

Good morning, everybody. Just two questions on EVX05. I was curious if you could perhaps delineate when we might expect to see some more news out of that program. And then if you could elaborate a little bit on the specific role that Duke played in the development up to date.

Sure.

Brigitte? Yeah, so the collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic. So we received sequencing data for some of those and were able to to identify, first we did our personalized approach looking into the profiles of the ERV and new antigen expression and then as EVXO4 were in parallel progressing and this yeah, off-the-shelf concept we're developing, we were able to use some of the same approaches and analyze these samples for identifying conserved herbs, and we were very pleased to see that across these many patients there were shared features indicating that we could definitely generate an off-the-shelf or design an off-the-shelf therapy. It's still, as I mentioned a bit early in the development path, we have conducted and concluded on what we would call target discovery. So selecting the targets that will be included in the vaccine, and we are now heading towards the lead selection. We've designed several different candidates that are now being experimentally tested. And then it's the classical path with R&D enabling activities and then the first in human study. We have not yet settled entirely on a timeline for all of these activities, but that's what we are working on at the moment.

More to come.

More to come, definitely. Absolutely.

Thank you. Thank you. We are now going to move to our next question. And this one comes from R.K. from H.C. Wainwright. Please go ahead.

Thank you. Good afternoon, Helen, Brigida, and Thomas. There are a few questions from me, but hopefully I could go one at a time. Starting off on EVX-01, obviously, it was exciting to see yesterday's news from the Merck-Moderno collaboration because it validates, you know, the program that you have been working on for a while now. So, going into ESMO, you know, for the three-year EVX-01 extension data, Brigada, what would you consider a clinically meaningful durability result, you know, that can, you know, especially in the standalone vaccine period and how would that help your discussions with either the partners that are currently looking at this program or even, you know, the AI model itself that helped generate EVX-01 on a broader perspective?

Yeah. So for the EVX-01 clinical data that we would like to see at ESMO is basically that we have almost the same or even improved overall response rate. So we should remember that these patients, advanced metanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the five-year mark is actually having a severe disease or even, yeah, passed away. So there is definitely a high medical need for these patients. And so we would like to see that we have doable responses, so the same number of patients remains in responses at the two-year mark, and further that the T-cell responses are maintained. So we would consider that as positive data, positive outcome of this extension phase. And then you had an additional comment around how this data would potentially support partner discussions. So there's no doubt that the more data, positive data we can generate would be appreciated by these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive in or supports us in these discussions and we have been waiting the whole field has been waiting for these phase three data for a long time and it's not just a win for the Moderna and Merck but it's actually a win for the whole for the whole field so and so definitely we see this as very encouraging and positive and not just, yeah, bad competitor news. It's very positive.

Perfect.

Then going on to the off-the-shelf molecule, Levy XL4, in terms of getting it ready to get into the clinic, you know, what are the gating steps here? So, you know, is it manufacturing, is it CMC, or making sure that you have ENF investigators who will do the right thing when you start taking this into the clinic?

Yeah, so EVX 04 is, we have done target discovery, we have selected the lead, and now we are conducting IND-enabling activities, so that includes the GMP manufacturing, and then of course we need to check that the molecule that is produced is also capable of driving a strong immune response. And then at the same time, we're also engaging with clinical sites, ensuring that we have a setup for testing the EVXO4 molecule. We plan to take this program into the clinic but we are of course always interested and are engaging with companies. So yeah, but it's not necessarily dependent on us entering into a partnership.

Yeah and all of those activities are ongoing and on track, so I think in terms of clinical sites, protocol development, GNC production compiling the necessary regulatory documentation so that contributes to our time frame that we have publicly no change there, no concern at the moment with all those activities and on track with the communicated timelines of regulatory filing by the end of the year Thank you.

I got a couple more questions. One for Helen. So, you know, you and, you know, even the previous management have been kind of talking about potential partnerships over a couple of quarters now. At this point, you know, what can you tell us in terms of where some of these discussions are um and and if you if you would like to characterize the stage of the most advanced ones you know where are they at you know are they like at the due diligence part the exploratory part or you're almost you know in the hands of the lawyers and waiting for them to to to get get things um you know put into print sure so that's it that's an obvious you know it's a good question Okay, but one I can't really answer as transparently as you would like.

I would say in our oncology conversations, obviously clinical data that we have, that Gideon has talked about, particularly EVX1, has been very meaningful. But I think the, to some extent, validation of the whole field in terms of having, you know, seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact. So I think whilst we've been doing various levels of dialogue and diligence, things have been somewhat, you know, there's sort of a wait to see how the field pans out. And I think hence beginner's comments earlier about the positive endorsement that this provides for all of us who think have programs that are actually quite differentiated in terms of what they can offer and beyond melanoma as well. um so in amongst all of that i think that you know the the novelty around the earth platform the ability to find the conserved antigens from the dark genome has also piqued quite a bit of interest and coming in with a second program there in a highly difficult very difficult to treat uh brain cancer and accelerates that interest so um you know i've been doing bd for 20 odd years and things can go very fast when there's motivation and competition, and sometimes, you know, it can take two years. So, I would say that we are in active conversations, and obviously, we'll be very happy to update when we can.

Thank you. One last question from me. So, Tomas, you know, when we look at your operations in the first half, the cash use was about $8.3 million And, you know, it looks like your quarterly burn rate is about like $4 plus million. So, against the $14 million that you have in the bank now, you know, can you walk us through your assumptions of how to get into second half 27? seven. And, you know, are you expecting, you know, cash infusion either organically or non, you know, inorganically?

Yeah. Yeah. No, good. Thanks, Arke. So, so maybe the first part of your question. So our cash out is not linear in the sense of each quarter just to extrapolate that. So of course, what we've seen and done in Q2, even in Q1, isn't just automatically to be extracted for the full year. There are some differences. Now, we are and will expect to remain on that level that we've communicated. Also, that's roughly 14 million for the year. We might, and I would expect to be even slightly lower than that. So it's not a round figure as such. We do have, of course, 14 million, as you rightfully have seen on the bank account. Please also do remember, of course, that there are some normal fluctuancies based on we're predominantly a DKK-based company versus the U.S. So there are some fluctuations from a pure Forex perspective into that also. On top of that, we still do expect that with the runway and with the focus on where we spend, how we spend, that we still, as mentioned earlier, can confirm that we are in the second half of 2027. And we will, of course, utilize the different things that we have available to us. One is also, not that that has gone in, I should start saying, into the plan in terms of how we've communicated HAARP to 27, but we do have an ATM to a facility that we can make use of. And actually, just as of yesterday, we also activated some of that ATM also in the market. So based, of course, on the positive news, as we've seen, and the volume in our price. So we will make use of those type of possibilities from an ATM perspective. Plus, of course, when we also, at a point in time, announce deals or partnerships, that will certainly also add to it. But with the current straight runway and with our prioritized programs, we are very confident that we will go and get into the second half of 2027.

Thank you. Thank you all for taking all my questions.

Thank you. Thank you. So we are now going to take our next question. And this question comes from Deepanjana Chattery from Johns. Please go ahead.

Hi, good morning, everyone. This is Avni on for Deepanjana. We had a few questions as well. So the first one that we wanted to ask was which glioblastoma patients are most likely to benefit from the EVX 05 cancer vaccine that you are developing?

So we haven't specified a specific population.

We're still working on identifying or we're still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal set of the most optimal patient population. And further, we are, of course, also looking into standard of care and combination therapies. One should be a little bit cautious on combining a vaccine with chemotherapy. So there might be an option of going into those patients that are not benefiting from clinical chemotherapy treatments, but we haven't entirely settled on the specifics around the clinical trial design.

Okay, and then as a quick follow-up, so what should we expect as the timeline for initiating that first in-human clinical trial, and what are some key milestones that investors should be watching for before that trial initiates?

Yeah, so we are early in the pre-clinical development, we've concluded on target discovery. So using our AI immunology for mining the patient data, and now have a set of optimal that will be included in the EDXO5 vaccine. So we are screening, we have designed several different. The vaccine candidates are now experimentally testing those to select the lead candidate. And then it's the classical activities, IND activities prior to the first in human study. And as mentioned, we're working together with Duke University. We haven't communicated any firm timelines on this program as we needed. We need to see, first of all, lead selection before we start communicating timelines.

We're leveraging the same platform for EVXO4 and EVXO5 in terms of delivery methodology, which definitely will use the expertise and experience there from the GMP production side So more to come on the timelines, but certainly there's a lot we know about how to bring this kind of platform forward, given the way we've done it already for EVXO4.

No, thank you for that color. And then as a final question, so beyond glioblastoma, how broadly applicable do you believe the ERV targeting approach could be across various solid tumors? And then broadly, how does the EVXO5 fit into the long-term strategy of building that AI-driven oncology franchise?

Yeah, so we have worked a lot in using AI immunology to mine patient data across several different indications. And we do see that there are several patients of the types where they have shared birth antigens. So there's definitely an option of applying this approach more broadly, but it is dependent on the profiles of those indications but definitely more options for scaling this into other solid tumors and also hematologic and I think what's interesting is that often where there's not a high mutational burden, there often is a high IRV frequency, and that's what we've been looking into.

So often where there isn't an opportunity to take a personalized approach forward because of low mutational burden, that doesn't seem to be the case with the IRVs. And so more to come on that as we've been teasing this apart. So we think it really does broaden out the opportunity in terms of the cancer vaccine approach for novel targets.

Thank you. Exciting times ahead. I appreciate you taking my questions. Thank you. Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone. That is star 1 and 1 to ask a question. There seems to be no further questions for today, so I will hand the call back to Helen for closing remarks.

Thank you, and thank you, everyone, for listening in today and for the excellent questions that we've had. We're really excited about the operational momentum that we've been able to deliver, about the interest in the programs coming in on the back of a really exciting time for personalized cancer vaccines in the whole field. So, exciting things to come, and we look forward to updating you further in the second half of the year. Thank you.