EVAX Evaxion A/S
$3.31
Evaxion A/S Q2 F2026 Earnings Call Transcript
AI Conference Call Analysis
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Conference Operator
Good day and thank you for standing by. Welcome to the Vaxion business update and second quarter 2026 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please, go ahead.
Helen Tayton-Martin
Chief Executive Officer
Thank you, speaker. I'm Helen Tayton-Martin. I'm the chief executive of Oveaction, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Rono, 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 Schmidt, 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 of 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 pipeline. 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 EVXO1 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 Merck 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 herb 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 and herb antigens in AML. So we've presented new preclinical data on that earlier this year at the European Haematology Association conference, annual conference. And we've also updated in our infectious disease portfolio on EVXV1, CMV program two at the recent HSE, Herpes Sublux conference last month. More broadly on AI immunology, the platform itself, we were really delighted to see that recognized in the Galeon UK award, a second Galeon award we have had for the technology in the last 12 months. So very exciting to see that being recognized more broadly, more globally in terms of the value in AI immunology prediction for our programs 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 funder 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 Birgitte's presentation in a few moments and obviously also including our EVXO4 and EVXO5 programmes which are focused on the conserved of off-the-shelf antigen vaccines. In infectious diseases we have a number of preclinical programmes 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 programmes 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 ESMO 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 and preclinical validation advantages 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.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
Thank you Helen. So today I'll focus on our lead asset EVXO1 so that our personalized new antigen cancer vaccine currently in phase two in advanced melanoma. Then I'll present our new official vaccine program demonstrating the stability 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 So, as Helen mentioned, we'll present three-year effects or one 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-PD1 treatment. The data will potentially give further insight into enhanced treatment effects and also the durability of EVX01-induced immune responses. And collectively, these data provide a more comprehensive assessment of the full potential of EVX01, so strengthening the already strong clinical data package. So looking back at previously announced data from the EVX01 phase 2 trial, we reported strong EVX01-induced immune activation at the AACR meeting in April. So we were able to show that 86% of the EVX01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than what has been reported and 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 T cell responses has been linked to clinical benefit. And at the ESMO Congress last year, we recorded 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 and improve clinical response upon EVXO1 treatment. So over the last approximately 10 years, personalized new antigen vaccines have 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. So let's turn our focus to our off-the-shelf cancer vaccine programs. So in collaboration with Duke University, we are developing an off-the-shelf vaccine EVXO5 for glioblastoma or GVM. 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 unmet medical need. So our EVEXO5 approach builds on the same novel and broadly applicable concept as EDX04 as it is designed with AI immunology to target conserved tumor-specific antigens derived from endogenous retrovirus elements or ERVs which are part of the dark genome. The target selection process allows for broad tumor coverage despite immune and tumor ERV 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-patient relevance and immunogenic potential. And we have mined patient sequencing data, identifying approximately 1.5 million ERG fragments and selected 16 of these as the fragments that will be included in the EVXO5 vaccine. So next steps include lead candidate selection and IND enabling activities prior to a first in human study that is expected to be conducted in collaboration with the world leading and GDM experts we are collaborating with at Duke University. So our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. So EVX-01 targets multiple conserved IRFs 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 ERG targets included in the EVXO4 vaccine activate human immune cells across different HLA types, and that these active immune cells can mediate targeted cell killing, indicating not only immune recognition, but also relevant functional impact of these vaccine-induced immune cells. So collectively, these data highlight and E.V.X. or false potential as a new effective therapeutic cancer vaccines. And we look forward to reporting further data as the program progresses towards regulatory filing data this year. So another promising program presented at a scientific conference during the summer is our E.V.X. V1 for the cytomegalovirus or CMV vaccine program. So in EVXV1, 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 T-cell 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 known B-cell antigens to reduce viral infection. And the data will guide antigen selection a broadly protected CMV vaccine candidate and as such represent a very important step towards 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. Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ERV 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 procedures. 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.
Thomas Schmidt
Chief Financial Officer
Perfect. Thank you Birgitte. 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 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 G&A 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 Birgitte 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. We have a cash position at the end of the quarter of 14 million. 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.
Helen Tayton-Martin
Chief Executive Officer
Thanks, Thomas, and thanks, Tegida. 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 EVX05 from all of our activities, but still maintaining our cash runway 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. Thank you. To ask a question, you will need to press star 1 and 1 on your telephone and wait for your name to be announced.
Operator
Conference Operator
To withdraw your question, please press star 1 and 1 again. One moment for our first question. And this question comes from Thomas Flaten from Lake Street Capital Markets. Please go ahead.
Thomas Flaten
Analyst, Lake Street Capital Markets
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.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
Sure, Birgitte? 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 that they're treating in their clinic. So we received sequencing data for some of those and were able to identify, first we did our personalized approach looking into the profiles of the ERV and new antigen expression and then as EVX-04 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 and off-the-shelf or designing 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.
Helen Tayton-Martin
Chief Executive Officer
So more to come.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
More to come, definitely.
Operator
Conference Operator
Thank you. Thank you. We are now going to move to our next question. And this one comes from RK from HC Wainwright. Please go ahead.
RK
Analyst, H.C. Wainwright
Thank you. Good afternoon, Helen, Birgitte, and Thomas. There are a few questions from me, but let me, hopefully, I could go one at a time. Starting off on EVX01, obviously, It was exciting to see yesterday's news from the Merck Moderna 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 EVX01 extension data, Birgitte, what would you consider a clinically meaningful durability result, 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 the and the AI model itself that helped generate EVX01 on a broader perspective.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
Yeah. So for the EVX01 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. 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 that is, 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 a partner. Yeah, so there's no doubt that the more data, positive data we can generate would be appreciated by in these discussions and I think The validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive or supports us in these discussions. We have been waiting, the whole field has been waiting for these Phase III data for a long time. And it's not just a win for Moderna and Merck, but it's actually a win for the whole field. So definitely we see this as very encouraging and positive and not just bad competitor news. It's very positive.
RK
Analyst, H.C. Wainwright
Perfect. Then going on to the off-the-shelves molecule, Levy XL4, in terms of getting it ready to get into the clinic, You know, what are the gating steps here? You know, is it manufacturing, is it CMC, or making sure that you have enough investigators who will do the right thing when you start taking this into the clinic?
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
Yeah, so EVX-04 is, we have done target discovery, we have selected the leads, 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 also engaging with clinical sites ensuring that we have a setup for testing the and 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.
Helen Tayton-Martin
Chief Executive Officer
And all of those activities are ongoing and on track. So I think in terms of clinical site protocol, development, GNC production, compiling the necessary regulatory documentation. So that contributes to our timeframe publicly. So no change there, no concern at the moment with all those activities.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
And on track with the communicated timelines of regulatory filing by the end of the year.
RK
Analyst, H.C. Wainwright
Thank you. I got a couple more questions. One for Helen. So, you know, you and 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 If you would like to characterize the stage of the most advanced ones, where are they at? Are they at the due diligence part, the exploratory part, or you're almost in the hands of the lawyers and waiting for them to get things put into print?
Helen Tayton-Martin
Chief Executive Officer
Sure, so that's an obvious, you know, it's a good question RK, 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 Birgitte has talked about, particularly with EVX1, has been very meaningful. But I think to some extent the validation of the whole field in terms of 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 that there's sort of a wait to see how the field pans out and I think hence Begina's comments earlier about the positive endorsement that this provides for all of us who think have you know programs that are actually quite differentiated in terms of what they can offer and beyond melanoma as well. So in amongst all of that I think that you know the novelty around the IRV 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 brain cancer, I know accelerates that interest. So I've been doing BD for 20 odd years and things can go very fast when there's motivation and competition and sometimes it can take So I would say that we are in active conversations and obviously we'll be very happy to update when we can.
RK
Analyst, H.C. Wainwright
Thank you. One last question from me. So Thomas, when we look at your operations in the first half, the cash use was about $8.3 million. It looks like your quarterly burn rate is about four plus million. So against the 14 million that you have in the bank now, can you walk us through your assumptions of how to get into second half 27? And are you expecting cash infusion either organically or inorganically?
Thomas Schmidt
Chief Financial Officer
Yeah, no, good. Thanks, RK. 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 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 are predominantly a DKK-based company versus the US. 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. 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 communicated half to 27, but we do have an ATM 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.
RK
Analyst, H.C. Wainwright
Thank you. Thank you all for taking all the questions.
Operator
Conference Operator
Thank you.
Thomas Flaten
Analyst, Lake Street Capital Markets
Thank you.
Operator
Conference Operator
Thank you. We are now going to take our next question. And this question comes from Dipanjana Chattery from Jones. Please go ahead.
Avni
Analyst, Jones
Hi. Good morning, everyone. This is Avni on for Dipanjana. 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 EVX05 cancer vaccine that you are developing?
Operator
Conference Operator
We haven't specified the specific population.
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
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 and the most optimal patient population. And further, we are of course also looking into standard of care and combination therapies. We want to 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 classical chemotherapy. but we haven't entirely settled on the specifics around the clinical trial design.
Avni
Analyst, Jones
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?
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
Yeah, so we are early in the preclinical development We've concluded on target discovery, so using our AI immunology for mining the patient data and now have a set of optimal births that will be included in the EVX05 vaccine. So we are screening, we have designed several different vaccine candidates and now experimentally testing those to select the lead candidate. And then it's the classical activities, IND enabling activities prior to the first in human studies. And as mentioned, we're working together with Duke University. We haven't communicated any firm timelines on this program as we need to see, first of all, the selection before we start communicating timelines.
Helen Tayton-Martin
Chief Executive Officer
a platform for EVXO4 and EVXO5 in terms of delivery methodology which definitely will use the expertise and experience there from the GMP production side of things so more to come on the timelines but certainly you know 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
Avni
Analyst, Jones
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 EVX05 fit into the long-term strategy of building that AI-driven oncology franchise?
Birgitte Rono
Chief Scientific Officer & Chief Operating Officer
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 certain patients of the types where they have shared birth antigens. So there's definitely an option of applying this approach more broadly, but it's dependent on the profiles of those indications. But definitely, more options for scaling this into other solid tumors and also hematologic .
Helen Tayton-Martin
Chief Executive Officer
And I think what's interesting is that often where there's not a high mutational burden, they think that there often is a higher frequency, and that's what we've been looking into. So often where there isn't an opportunity to take a personalized Thank you. Exciting times ahead. I appreciate you taking my questions.
Operator
Conference Operator
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.
Helen Tayton-Martin
Chief Executive Officer
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, the 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.
Operator
Conference Operator
Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.