管理層發言
Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Second Quarter 2026 Financial Results. Please note the operator provided instructions. 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.
Thank you. I'm Helen Tayton-Martin. I'm the Chief Executive of Evaxion, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Røno, our Chief Scientific Officer and Chief Operating Officer, 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 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 Evaxion programs and pipeline.
We've had a new 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. 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. It was a great day for the field yesterday to see the positive Phase III results from the similar Moderna and Merck program in personalized cancer vaccine in melanoma. It will be great for us and the field to talk more about that as we head into ESMO and provide an update on our own data there. Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVX-03 and EVX-01 platforms into a new program, which we call EVX-05 in glioblastoma, where we are further leveraging the endogenous retrovirus elements that we have been able to identify—highly conserved ERV antigens for glioblastoma—building on what we have done in our EVX-04 program using a similar approach to use AI-Immunology to find highly conserved ERV antigens in AML.
We presented new preclinical data on that earlier this year at the European Hematology Association Annual Conference. We've also updated our infectious disease portfolio on our EVX-V1 CMV program at the recent Herpes Simplex Conference last month. More broadly, on AI-Immunology, the platform itself, we were really delighted to see that recognized 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 recognition more broadly and globally in terms of the value of AI-Immunology prediction for our programs in infectious disease, oncology, and autoimmune disease. Finally, in terms of the core of our updates, we have maintained a disciplined focus on our resource allocation, strongly aligned to where we can build the most value from the platform. With that discipline, we can confirm that our cash runway remains unchanged, with the cash at hand to fund our operations into the second half of 2027; 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. EVX-01 will be a focus for Birgitte's presentation in a few moments and also includes our EVX-04 and EVX-05 programs, which are focused on the conserved off-the-shelf antigen vaccines. In infectious diseases, we have a number of preclinical programs, some of which are partnered, one with Merck and one with Afrigen, and data is continuing to build around the interest that we have in those programs from partners. As we meet the halfway point of 2026, we have already met the first of our milestones in terms of updating on the EVX-01 platform at AACR earlier this year with biomarker and immunogenicity preclinical data alongside the clinical data from year 2 at ESMO last year. We will be updating on the 3-year data from that program with efficacy results at ESMO in October.
In the rest 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 the EVX-04 off-the-shelf program in AML. Finally, we will have an update on our Group A Strep program with the design and preclinical validation of antigens in EVX-B4. We continue to pursue a partnership approach around these programs and platforms where we see value creation. With that, I'll hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.
Thank you, Helen. Today, I'll focus on our lead asset, EVX-01, our personalized neoantigen cancer vaccine currently in Phase 2 in advanced melanoma. Then I'll present our new off-the-shelf EVX-05 vaccine program, demonstrating the scalability of our AI-Immunology platform into the hard-to-treat and deadly brain cancer glioblastoma. Lastly, I'll showcase how AI-Immunology-identified T cell epitopes are relevant in controlling CMV infections. As Helen mentioned, we will present 3-year EVX-01 Phase 2 outcome data at the ESMO Congress in October. This data includes evaluation of the vaccine's effect as a stand-alone and also in combination with anti-PD-1 treatment. The data will potentially give further insight into enhanced treatment effects and the durability of EVX-01-induced immune responses. Collectively, these data provide a more comprehensive assessment of the full potential of EVX-01, strengthening the already strong clinical data package.
Looking back at previously announced data from the EVX-01 Phase 2 trial, we reported strong EVX-01-induced immune activation at the AACR meeting in April. We showed that 86% of the EVX-01 vaccine targets triggered a tumor-specific immune response, which is a substantially higher frequency than has been reported for other similar vaccine candidates. Furthermore, we showed that 86% of the immunogenic vaccine targets induced a de novo T cell response, meaning that EVX-01 specifically triggers novel T cell responses rather than amplifying existing responses. This is important, as induction of de novo T cell responses has been linked to clinical benefit. At the ESMO Congress last year, we reported 2-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. Importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment.
Over the last approximately 10 years, personalized neoantigen vaccines have shown promise across several early-phase clinical studies. With the Moderna and Merck announcement yesterday, we can 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. These data are not only a win for Moderna and Merck; they are a win for the entire field as they broadly validate the personalized neoantigen vaccine concept. With our encouraging EVX-01 data and the validation from Moderna and Merck, we believe we are well-positioned to move forward toward further value creation. Turning to our off-the-shelf cancer vaccine programs, in collaboration with Duke University we are developing EVX-05 for glioblastoma targeting conserved antigens as announced earlier this week. Glioblastoma is the most common and most aggressive primary malignant brain tumor.
Despite surgery followed by chemoradiation, outcomes remain very poor with a median overall survival of approximately one year, underscoring a significant unmet medical need. Our EVX-05 approach builds on the same novel and broadly applicable concept as EVX-04: 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 antigen differences across patients. We applied AI-Immunology, our AI-powered target discovery approach, and identified an optimal set of ERV fragments based on cross-patient relevance and immunogenic potential. We mined patient sequencing data, identifying approximately 1.5 million ERV fragments, and selected 16 of these fragments to be included in the EVX-05 vaccine. 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 GBM experts at Duke University.
Our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. EVX-04 targets multiple conserved ERVs identified in AML patient samples. As Helen mentioned, we presented novel data at the European Hematology Association Congress in June demonstrating that the EVX-04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation. We showed that the 16 ERV targets included in the EVX-04 vaccine activate human immune cells across different HLA types and that these ERV-reactive immune cells can mediate targeted cell killing, indicating not only immune recognition but also relevant functional impact of these vaccine-induced immune cells. Collectively, these data highlight EVX-04's potential as a new effective therapeutic cancer vaccine. We look forward to reporting further data as the program progresses toward regulatory filing later this year.
Another promising program presented at a scientific conference during the summer is our EVX-V1 cytomegalovirus (CMV) vaccine program. In EVX-V1, we are using AI-Immunology to design known targets—optimizing them—and to identify previously unexplored vaccine targets. At the International Herpesvirus 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 reactivation in CMV-infected mice. 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. The data will guide antigen selection for a broadly protective CMV vaccine candidate and represent an important step forward for EVX-V1. Having highlighted progress across our key R&D programs, let's focus on our AI-Immunology platform and the data validating its ability to generate high-quality product candidates.
AI-Immunology is clinically validated with positive outcomes 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. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. Additionally, the novel ERV-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. AI-Immunology supports multiple modalities, including peptides, recombinant proteins, DNA, and RNA platforms, enabling both pipeline and partnering potential. In conclusion, we have demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. With that, I'll hand over to Thomas, who will present our quarterly financial results.
Perfect. Thank you, Birgitte. Let me jump straight into the presentation of the financial results for the second quarter of 2026. The main highlights for the quarter are that we have continued our disciplined resource allocation throughout our strategic direction, aligned to the priorities around the value drivers that we defined and communicated earlier this year. We are on track to deliver according to our financial plan, which shows in the Q2 results and is confirmed by our cash position. As mentioned by Helen, we reconfirm that our cash runway runs into the second half of 2027. Looking closer at our profit and loss statement for the quarter, overall we see slightly reduced operating expenses, mainly driven by lower general and administrative costs where we had significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses show a slight increase versus last year, fully aligned with the progress Birgitte mentioned on EVX-01, EVX-04, and EVX-05.
These programs are confirmed within our cash runway through the first half of 2027. We reported a net loss for the period of $3.7 million, on plan and following the execution we set for this year. Balance sheet: cash position at the end of the quarter was $14 million. We reconfirm our cash runway, and equity reflects the result for the first six months, with equity at $9.5 million at the end of the second quarter. All in all, a good financial performance aligned with expectations and the progress of our platform and portfolio. With that, I hand it back to Helen for some concluding remarks.
Thanks, Thomas, and thanks, Birgitte. In conclusion, I want to emphasize that we've seen strong operational momentum on our set milestones and a new program emerging with EVX-05 from our activities, while still maintaining our cash runway into the second half of 2027. We're excited by the stream of new data validating that AI-Immunology can deliver meaningful products for future development. That underpins our ongoing business development discussions as we evaluate which programs we will bring forward and with which partners. With that, we are happy to take questions, and thank you for your attention.
分析師問答
The floor is now open for questions. This question comes from Thomas Flaten from Lake Street Capital Markets.
Just two questions on EVX-05. I was curious if you could delineate when we might expect to see more news out of that program. And could you elaborate on the specific role that Duke played in the development to date?
Sure. Birgitte?
The collaboration with Duke has been ongoing for some time. They have a lot of sequencing data from the patients they treat in their clinic. We received sequencing data from some of those patients and were able to identify—first using a personalized approach to look into the ERV and neoantigen expression profiles. As EVX-04 progressed in parallel and this off-the-shelf concept was developed, we used the same approaches to analyze the samples for finding conserved ERVs. We were pleased to see shared features across many patients indicating we could design an off-the-shelf therapy. It is still early in development. We conducted and concluded target discovery, selecting the targets that will be included in the vaccine, and we are now heading toward lead selection. We have designed several different candidates that are now being experimentally tested. Then it's the classical path with IND-enabling activities and a first-in-human study. We have not yet settled entirely on a timeline for all these activities, but that's what we are working on at the moment.
So more to come.
More to come, definitely.
We are now moving to our next question, and this one comes from RK from H.C. Wainwright.
There are a few questions from me. Starting off on EVX-01—obviously, it was exciting to see yesterday's news from the Merck and Moderna collaboration because it validates the program you have been working on. Going into ESMO for the 3-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability result, especially in the stand-alone vaccine period? And how would that help your discussions with partners or the AI model itself that helped generate EVX-01 more broadly?
For the EVX-01 clinical data we'd like to see at ESMO, we would expect almost the same or even an improved overall response rate. Remember that advanced melanoma patients receiving only checkpoint inhibitors often have poor long-term outcomes; many patients have severe disease or have died by the five-year mark. There is a high unmet medical need. We would like to see durable responses—patients remaining in response at the three-year mark and maintained T cell responses—and we would consider that a positive outcome of this extension phase. Regarding partnership discussions, the more positive data we can generate, the better for those conversations. The validation that came out yesterday of the personalized cancer vaccine concept is supportive; the whole field has been waiting for Phase III data. It's not just a win for Moderna and Merck; it's a win for the whole field, and we see this as very encouraging and positive.
Perfect. Then moving to the off-the-shelf molecule EVX-04: in terms of getting it ready for the clinic, what are the gating steps? Is it manufacturing, CMC, or ensuring you have the right investigators and sites ready for the clinical trial?
For EVX-04, we have completed target discovery and selected the lead. We are conducting IND-enabling activities, which include GMP manufacturing. We need to ensure that the produced molecule can drive a strong immune response. At the same time, we are engaging clinical sites and ensuring we have a setup for testing EVX-04. We plan to take this program into the clinic, and we are engaging with potential partners, but it is not dependent on us entering into a partnership.
All of those activities are ongoing and on track. Clinical site engagement, protocol development, GMP production, and compiling the necessary regulatory documentation are contributing to our publicly communicated timeframe. There is no change and no concern at the moment with those activities.
And we remain on track with the communicated timelines for regulatory filing by the end of the year.
I have a couple more questions. One for Helen. You and previous management have been discussing potential partnerships for a couple of quarters. At this point, where are those discussions? If you can characterize the stage of the most advanced ones: are they in exploratory due diligence, or are they almost in legal review waiting for agreements to be signed?
That's a good question, RK, but one I can't fully answer publicly. In oncology, our clinical data, particularly for EVX-01, has been meaningful. The broader validation of the field—seeing a registrational program—has impacted discussions. While we've had various levels of dialogue and diligence, part of the market was waiting to see how the field would evolve. The validation from the recent Phase III results is helpful for all of us with differentiated programs. The novelty around the ERV platform and the ability to find conserved antigens in the dark genome has piqued interest. Having a second program in a difficult-to-treat cancer accelerates that interest. In business development, things can move quickly when motivation and competition align; sometimes they can take longer. I would say we are in active conversations, and we'll provide updates when we can.
One last question for Thomas: when we look at operations in the first half, cash use was about $8.3 million and the quarterly burn rate looks roughly $4-plus million. Against the $14 million you have in the bank, can you walk us through the assumptions to reach the second half of 2027? Are you expecting any cash infusions, either organically or inorganically?
Thanks, RK. Our cash outflow is not linear quarter to quarter, so you cannot simply extrapolate Q2 for the full year. While Q1 and Q2 provide data points, there are fluctuations. We expect to remain at the level communicated and may even be slightly lower; the $14 million is the cash balance. Remember, we are predominantly a DKK-based company, so there are foreign exchange fluctuations. With our runway and prioritized spending, we confirm the runway into the second half of 2027. We will use the different financing tools available to us. We have an ATM facility we can use; we activated some of that ATM in the market yesterday based on positive news and trading volume. We may also announce deals or partnerships that would add to our cash position. With the current runway and our prioritized programs, we are confident we will reach the second half of 2027.
We are now going to take our next question. This question comes from an analyst on behalf of Debanjana Chatterjee from Jones.
We have a few questions. First, which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine you are developing?
We haven't specified a specific patient population yet.
We are still working on identifying different patient subsets by looking at ERV profiles and determining the most optimal patient population. We are also considering standard-of-care and combination therapies; one should be cautious combining a vaccine with chemotherapy. There may be an option to go into patients who are not benefiting from classical chemotherapy, but we haven't settled on the specifics of the clinical trial design.
As a quick follow-up, what is the timeline for initiating the first-in-human study for EVX-05, and what key milestones should investors watch for before that trial initiates?
We are early in preclinical development. We concluded target discovery using AI-Immunology, yielding a set of optimal ERVs for inclusion in EVX-05. We are screening and experimentally testing several designed vaccine candidates to select the lead. Then we will conduct IND-enabling activities prior to the first-in-human study. We are working with Duke University. We have not communicated firm timelines; we need lead selection before we provide timelines.
We're leveraging the same platform for EVX-04 and EVX-05 in terms of delivery methodology, which will use the expertise and experience from GMP production and from bringing EVX-04 forward. More to come on timelines, but we have experience that will help accelerate development.
Beyond glioblastoma, how broadly applicable do you believe the ERV-targeting approach could be across various solid tumors? And how does EVX-05 fit into the long-term strategy of building an AI-driven oncology franchise?
We have used AI-Immunology to mine patient data across several indications and see certain patient subtypes with shared antigens. There is an option to apply this approach more broadly, dependent on the profiles of those indications. There are certainly options for scaling this into other solid tumors and hematologic malignancies.
Often where there's not a high mutational burden, there can be a higher ERV frequency, which is what we've investigated. Where a personalized approach is harder due to low mutational burden, ERVs can still provide targets. We think this broadens the opportunity for cancer vaccine approaches to novel targets.
There are no further questions at this time. I will hand the call back to Helen for closing remarks.
Thank you, and thank you, everyone, for listening today and for the excellent questions. We're excited about the operational momentum we've delivered and the interest in our programs, which is increasing on the back of exciting times for personalized cancer vaccines across the field. We look forward to updating you further in the second half of the year. Thank you.
This concludes today's conference call. Thank you for participating. You may now disconnect.