Evaxion (EVAX) Telefonkonferenz zu den Ergebnissen des Q2 2026: 14 Mio. USD Barmittel und EVX-01-Update

Wichtigste Erkenntnisse

• Evaxion beendete das zweite Quartal 2026 mit 14,0 Millionen US-Dollar an liquiden Mitteln, während das Management bekräftigte, dass die Finanzierung den Betrieb voraussichtlich bis in die zweite Hälfte des Jahres 2027 sichern wird.
• Das Unternehmen meldete für das zweite Quartal einen Nettoverlust von 3,7 Millionen US-Dollar. Die Betriebsausgaben sanken im Jahresvergleich, da geringere G&A- und Kapitalmarktkosten einen leichten Anstieg der F&E-Ausgaben ausglichen.
• Evaxion plant, im Oktober 2026 auf dem ESMO-Kongress Drei-Jahres-Wirksamkeitsdaten der Phase II für EVX-01 bei fortgeschrittenem Melanom vorzulegen, einschließlich der Dauerhaftigkeit klinischer Reaktionen und T-Zell-Antworten.
• Zuvor veröffentlichte Daten zu EVX-01 zeigten eine Gesamtansprechrate von 75 % nach zwei Jahren, wobei 92 % der ansprechenden Patienten weiterhin ein Ansprechen zeigten. Auf der AACR-Tagung erzeugten 86 % der Impfstoff-Zielstrukturen tumorspezifische Immunantworten.
• Für den Glioblastom-Kandidaten EVX-05 untersuchte das Unternehmen etwa 1,5 Millionen von endogenen Retroviren stammende Fragmente und wählte 16 für das Impfstoffdesign aus. Ein Zeitplan für die erste Anwendung am Menschen wurde noch nicht festgelegt.
• EVX-04 liegt laut Management weiterhin im Plan für eine behördliche Einreichung bis Ende 2026, wobei die GMP-Herstellung, die Vorbereitung klinischer Prüfzentren und weitere Vorarbeiten für den IND-Antrag laufen.

Wichtige Finanzdaten

Geschäfts- und operative Entwicklung

EVX-01: Drei-Jahres-Melanomdaten im Oktober erwartet

EVX-01 ist der personalisierte Neoantigen-Krebsimpfstoff von Evaxion in der Phase-II-Entwicklung für fortgeschrittenes Melanom. Das ESMO-Update im Oktober wird den Impfstoff sowohl als Monotherapie als auch in Kombination mit einer Anti-PD-1-Therapie bewerten.

Laut Management würde ein positives Ergebnis darin bestehen, die zuvor gemeldete Gesamtansprechrate aufrechtzuerhalten oder zu verbessern, das nach zwei Jahren beobachtete Ansprechen zu bewahren und eine anhaltende T-Zell-Aktivität nachzuweisen.

Zuvor veröffentlichte Ergebnisse der Phase II umfassten eine Gesamtansprechrate von 75 % nach zwei Jahren, wobei 92 % der ansprechenden Patienten weiterhin ansprachen. Mehr als die Hälfte der Patienten verbesserte ihr klinisches Ansprechen während der Behandlung mit EVX-01. Separate AACR-Daten zeigten, dass 86 % der EVX-01-Impfstoff-Zielstrukturen tumorspezifische Immunantworten auslösten, während 86 % der immunogenen Zielstrukturen neue T-Zell-Antworten erzeugten.

Das Management erklärte zudem, dass positive Phase-III-Ergebnisse des personalisierten Krebsimpfstoff-Programms von Moderna und Merck die breitere Validierung des therapeutischen Ansatzes stützen und Partnerschaftsgespräche stärken könnten.

EVX-05 erweitert die Pipeline an gebrauchsfertigen Onkologie-Wirkstoffen

EVX-05 ist ein gebrauchsfertiger Impfstoffkandidat gegen Glioblastome, der gemeinsam mit der Duke University entwickelt wird. Er nutzt die AI-Immunology-Plattform von Evaxion, um konservierte, tumorspezifische Antigene zu identifizieren, die von endogenen Retrovirus-Elementen im dunklen Genom abgeleitet sind.

Das Unternehmen analysierte Sequenzierungsdaten von Patienten, identifizierte etwa 1,5 Millionen Fragmente und wählte 16 für das Design von EVX-05 aus. Mehrere Impfstoffkandidaten durchlaufen derzeit experimentelle Tests, bevor die Auswahl des Leitkandidaten und Arbeiten für den IND-Antrag erfolgen.

Evaxion hat noch keinen Zeitplan für eine Erstanwendung am Menschen festgelegt. Das Unternehmen evaluiert zudem weiterhin Patientensubgruppen, Antigenprofile und potenzielle Behandlungskombinationen.

EVX-04 rückt näher an den Genehmigungsantrag

EVX-04 ist ein gebrauchsfertiges Krebsimpfstoff-Programm, das auf konservierte Antigene abzielt, die in Proben von Patienten mit akuter myeloischer Leukämie identifiziert wurden. Auf der Konferenz der European Hematology Association präsentierte Daten zeigten, dass seine 16 Zielstrukturen menschliche Immunzellen über verschiedene HLA-Typen hinweg aktivierten und das gezielte Abtöten von Zellen unterstützten.

Das Programm befindet sich nun in der Entwicklung zur Vorbereitung des IND-Antrags. Zu den aktuellen Arbeiten gehören die GMP-Herstellung, die Prüfung der Immunantwort, die Entwicklung klinischer Protokolle, die Einbindung von Prüfzentren und die Erstellung behördlicher Unterlagen. Das Management hielt an seinem Ziel fest, den Antrag bis Ende 2026 einzureichen.

EVX-D1 liefert zusätzliche präklinische ZMV-Daten

Auf dem International Herpesvirus Workshop im Juli präsentierte Evaxion Daten aus Mäusestudien, die darauf hindeuten, dass mit der AI-Immunology-Plattform entdeckte Epitope dazu beitragen könnten, akute Zytomegalievirus-Infektionen, Latenz und Reaktivierung zu kontrollieren. Die Ergebnisse werden die Antigen-Auswahl für einen breit schützenden EVX-D1-Impfstoffkandidaten unterstützen.

Ausblick des Managements

Evaxion bekräftigte, dass die vorhandenen Mittel den Betrieb priorisierter Programme voraussichtlich bis in die zweite Hälfte des Jahres 2027 finanzieren werden. Dieser Finanzierungszeitraum umfasst die geplanten Arbeiten an EVX-01, EVX-04 und EVX-05.

Das Management nannte zudem die folgenden erwarteten Meilensteine:

• Drei-Jahres-Wirksamkeitsdaten der Phase II für EVX-01 auf dem ESMO-Kongress im Oktober 2026.
• Weitere Informationen zur Nutzung der AI-Immunology-Plattform bei Autoimmunerkrankungen im Laufe des Jahres 2026.
• Ein geplanter Zulassungsantrag für EVX-04 bis Ende 2026.
• Fortführung der präklinischen Auswahl des Leitkandidaten für EVX-05, ohne festen klinischen Zeitplan.

Risiken und zu beobachtende Bereiche

• EVX-05 befindet sich weiterhin in einer frühen Phase der präklinischen Entwicklung, und das Unternehmen hat weder den Leitkandidaten noch die Zielpatientengruppe oder den Zeitplan für die Erstanwendung am Menschen final festgelegt.
• Der Investment-Case für EVX-01 hängt teilweise davon ab, ob die Drei-Jahres-Daten dauerhafte klinische Reaktionen und eine nachhaltige T-Zell-Aktivität bestätigen.
• Die Partnerschaftsgespräche dauern an, aber das Management nannte weder einen Zeitrahmen noch eine Garantie für den Abschluss einer Transaktion.
• Der quartalsweise Mittelabfluss kann schwanken und sollte laut Management nicht linear hochgerechnet werden. Auch Wechselkursschwankungen zwischen der Dänischen Krone und dem US-Dollar können die ausgewiesenen liquiden Mittel beeinflussen.
• Evaxion verfügt über eine At-the-Market-Eigenkapitalfazilität und gab bekannt, einen Teil davon vor Kurzem genutzt zu haben. Künftige Partnerschaften könnten zusätzliche Mittel bereitstellen, während der Telefonkonferenz wurde jedoch keine Transaktion angekündigt.

Wichtigste Fragen und Antworten aus der Analystenkonferenz

Was sind die nächsten Schritte für EVX-05?
Das Management gab bekannt, dass die Identifizierung der Zielstrukturen abgeschlossen ist. Evaxion testet derzeit mehrere Impfstoffdesigns experimentell, bevor ein Leitkandidat ausgewählt wird, gefolgt von standardmäßigen Vorarbeiten für den IND-Antrag. Ein fester klinischer Zeitplan wird erst veröffentlicht, wenn die Auswahl des Leitkandidaten weiter fortgeschritten ist.

Was würde aussagekräftige Drei-Jahres-Daten für EVX-01 ausmachen?
Das Management strebt eine stabile oder verbesserte Gesamtansprechrate, eine anhaltende Dauerhaftigkeit des Ansprechens bei den nach zwei Jahren ansprechenden Patienten sowie die Aufrechterhaltung der durch den Impfstoff induzierten T-Zell-Antworten an.

Was steht noch aus, bevor EVX-04 in die klinische Entwicklung eintreten kann?
Zu den wichtigsten Aktivitäten gehören die GMP-Herstellung, die Bestätigung der Immunaktivität, die Vorbereitung klinischer Prüfzentren, die Protokollentwicklung und die Fertigstellung der Einreichungsunterlagen. Laut Management liegen diese Aktivitäten weiterhin im Plan für eine Einreichung bis Jahresende.

Wie weit sind die Partnerschaftsgespräche fortgeschritten?
Das Management beschrieb die Gespräche als aktiv und auf verschiedenen Ebenen von Dialog und Due Diligence verlaufend, lehnte es jedoch ab, die am weitesten fortgeschrittenen Verhandlungen näher zu charakterisieren oder einen Zeitrahmen für eine Transaktion zu nennen.

Wie begründet das Unternehmen seine Schätzung der Liquiditätsreichweite?
Das Management erklärte, dass die Ausgaben pro Quartal nicht linear verlaufen, und bekräftigte seinen Fokus auf priorisierte Programme. Das Unternehmen kann zudem seine ATM-Eigenkapitalfazilität nutzen, während etwaige Erlöse aus künftigen Partnerschaften die verfügbaren Mittel aufstocken würden.

Vollständiges Transkript der Telefonkonferenz

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Second Quarter 2026 Financial Results. [Operator 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.

Helen Tayton-Martin

Thank you, speaker. I'm Helen Tayton-Martin, I'm the Chief Executive of Evaxion, and we're delighted today to be building our Q2 business update. I'm joined today on the call by Birgitte Rono, our CFO and COO, who will provide an overview of our updates on 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 4 core areas of 4 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 any discussions we are having with partners regarding the action programs and pipeline.

We've had a stream of very encouraging new data, which continues to come through and continuously validate the AI immunology panel, 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 Evaxion program. our personalized neoantigen cancer vaccine in advanced melanoma patients. And obviously, it was a great day for the field yesterday to see the Phase III -- positive Phase III 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 how we had to ESMO and an update on our own data there.

Elsewhere, we've been working to refocus and expand the pipeline, leveraging our learnings with our anti-1 platform actually into a new program, which we call EVX-05 in glioblastoma, where we are further leveraging the ores that we have been able to identify highly conserved antigens for glioblastoma, building on what we have done in our EVX-04 program using a similar approach to use their immunology to find highly conserved and [indiscernible] in AML. So we presented new preclinical data met earlier this year at the European Hematology Association Conference, Annual Conference. And we also updated in our infectious disease portfolio on EVX V1 CMV program to the recent HSV, [indiscernible] conference last month.

More broadly on AI Immunology, the platform itself, we were really delighted to see that recognized in the Gallian, a second Gallian 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 weight from the platform.

And with that, plan we can confirm that our cash runway remains unchanged with the 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. Evaxion will be a focus for [indiscernible] presentation in a few moments and obviously, also including our EVX-04 and EVX-05 programs, which are focused on the concerns of anti-off-the-shelf antigen vaccines.

For infectious diseases. We have a number of preclinical programs there and some of which are partnered 1 with Merck with Aprogen and data is continuing to build on 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 EVX-01 platform at AACR earlier this year with biomarker immunogenicity preclinical data alongside the clinical data from year 2 at ESMO last year.

We will -- we have mentioned already, and we will be updating on the 3-year data from that program with efficacy results in 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 EVX-04 program, the outer-shelf program in AML. And finally, we will have an update on our group [indiscernible] program in -- with the design and preclinical validation of antigens in the EVX-B4. 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 Birgitte, who will talk you through our R&D and AI immunology update.

Birgitte Rono

Thank you, Helen. So today, our focus on our lead asset, so that our personalized neoantigen cancer vaccine currently in place 2 in advanced melanoma. Then I'll present our new official 5 vaccine program. demonstrating the scalability of our AI immunology platform into the hard-to-treat and define brain cancer glioblastoma. So lastly, I'll showcase how the immunology identified T cell epitopes are relevant in controlling CMV infections. So as Helen mentioned, we will present 3-year effect 1 Phase II outcome data at the ASCO Congress in October, and this data includes evaluation of the vaccine's effect as stand-alone 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 EBX-01-induced immune responses. And collectively, these data provide a more comprehensive assessment of the potential of Evaxion, so strengthening the already strong clinical data page.

So looking back at previously announced data from the Evaxion Phase II trial, we reported strong EBX-01-induced immune activation at the AACR meeting in April. So we were able to show that 86% of the EVX-01 vaccine target 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 Novotel response, meaning that EX1 specific triggers, novelties and responses rather than amplifying existing responses.

This is very important as induction of the novel T cell responses has been linked to clinical benefit. And at the ESMO Congress last year, we recorded 2-year outcome data, including a 75% overall response rate complete responses and 92 of the patients still being in response, indicating doable clinical benefit. And importantly, more than half of the patients converted into an improved clinical response or current EVX-01 treatment. So over the last approximately 10 years, personalized new stream vaccines has shown promise across several early based 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 wind from Moderna and Merck, but it's a win for the entire field as they broadly validate the personalized new antigen vaccine concept. So overall, with our encouraging EVX-01 data and with the validation from Modena and Merck, we believe that we are well positioned as we move forward towards credit creation.

And so let's turn our focus to our after-shelf cancer vaccine programs. So in collaboration with Duke University, we are developing an after shelf vaccine, EVX-05 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 and despite surgery followed by chemo radiation outcomes remain very true up with a median overall survival of approximately 1 year, underscoring a significant unmet medical need. So our EVX-05 approach builds on the same novel and broadly applicable concept as EVX-04 as it is assigned with AI immunology to target conserved tumor-specific antigens debarred from endogenous retrovirus lens or beers, which are part of the dark genome.

The target selection process allows for a broad tumor coverage despite immune and tumor erbantigen differences across patients. So we have applied AI immunology. So our AI-powered target discovery across and identified an optimal set of bar fragments based on trust patients relevance and immunogenic percentage. And we have mined patient sequencing data identifying approximately 1.5 million [indiscernible] and selected 16 of this 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 study that is expected to be conducted in collaboration with the world-leading GM experts, we are collaborating with the GC University. So our other after-shelf cancer vaccine program, EVX-04 is also progressing well. So EVX-01 targets in multiple concerts in the case of this program identified in AML patient samples.

So as Sean mentioned, we presented novel data at the European Hematology Associates Conference in June demonstrating that the EVX-04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation. So further, we showed that the 16 [indiscernible] targets included in the EVX-04 activates human immune cell across different HLA types and that these immune cells can mediate targeted cell cooling, indicating not only in new recognition but also relevant functional impact of these vaccine-induced immune cells.

So collectively, these data highlights EBX 4 potential as a new effective therapeutic cancer vaccines and we look forward to report further data as the program progresses towards regulatory buying later this year.

Another promising program presented at a scientific conference during the summer is our EVX-D1 cytomegaly or CMV vaccine program. So in EVX-D1, we are using AI immunology to design a known target, so optimizing them and also to identify previously unexplored vaccine tires. And at the international Herpesvirus workshop in July, we presented new data demonstrating that [indiscernible] discovered with AI immunology have the potential to control acute infection, latency and also reactivating 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 broadly protective CMV vaccine candid and, as such, represent and a very important step towards for with the EVX-D1 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 3 out of 3 oncology trials. Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer, with our art targeting vaccines as well as in taxis diseases with several candidates against bacterial and viral pathogens.

And importantly, the EVX-01 concept is highly scalable with Presento in other solid tumors. And additionally, the novel air-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. So finally, AI analogy supports multiple modalities, including peptides, recombinant proteins, DNA and RNA platforms enabling both pipeline and powering percent. 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 will hand over to Thomas, who will present our quarterly financial results.

Thomas Schmidt

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 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 nightly reduced operating expenses mainly driven from our general and administration costs or 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 enhanced with all the progress that Birgitte just mentioned on EVX-01, EVX-04, EVX-05 and again, also those programs are confirmed within our cash runway until the half year 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 6 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 expectations 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

Thanks, Thomas, and thanks, Birgitte. So in conclusion, I would want to emphasize that we've seen some really good operational momentum on our asset milestones and actually new program emerging with EVX-05 from all of our activities but still maintaining 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 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.

Operator

[Operator Instructions]

And this question comes from Thomas Flaten from Lake Street Capital Markets.

Fragen und Antworten

Thomas Flaten

Just 2 questions on EVX-05. 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

Sure. Yes. So the collaboration with [indiscernible] has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinics. So we believe sequencing data for some of those, and we're able to identify. First, we did our presliced approach looking into the profiles of the EV and new antigen expression. And then as EXO we're in parallel progressing and this off-the-shelf concept we're developing. We were able to use some of the same approaches and analyze these samples for identifying conservatives and we were very pleased to see that across these many patients, there were at features indicating that we could definitely generate and off the shelf or the signing of the shelf therapy.

It's still, as I mentioned, a bit early in the development path. We have conducted and concluded we will call target discovery, so selecting the targets that will be included in the vaccine, and we are now heading towards lead selection -- we have designed several different candidates that are now being experimentally tested. And then it's the classical part with R&D-enabling activities and then the first in human study. We have not yet settled entirely on a time line for all of these activities, but that's what we are working on at the moment. So more to come, definitely.

Operator

We are now going to move to our next question. And this 1 comes from RK from C. Wainright.

Swayampakula Ramakanth

There are a few questions from me, but let me, hopefully, I could go 1 at a time. Starting off on EVX-01. Obviously, it was exciting to see yesterday's news from the Modena collaboration because it validates the program that you have been working on for a while now. So going into ESMO for the 3-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability results that can especially in the stand-alone vaccine period, and how would that help your discussions with either the partners that are currently looking at this program or even the AI model itself that helped generate EVX-01 on a broader perspective?

Birgitte Rono

Yes. 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 melanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the 5-year mark is actually having a severe disease or even, yes, pass away. So there is definitely a high unmet medical need for these patients. So we would like to see that we have durable responses.

So the same number of patients remain in response at the 2-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 base. And then you had an additional comment around how this data would potentially support a partner positive questions. Yes. 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 at the personalized cancer vaccine concept, definitely also is supportive in -- or supports us in these discussions.

And we have been waiting the wholesale has been waiting for these Phase III data for a long time. And it's not just a win for the Modena 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 -- yes, bad competitor is it's very positive.

Swayampakula Ramakanth

Okay. Then going on to the off-the-shelf molecule, EVX-04, in terms of getting it ready to get into the clinic, what are the gating steps here? Is it manufacturing? Is it CMC or making sure that you have enough investigators who would do the right thing when you're starting this into the clinic?

Birgitte Rono

Yes. So EVX-04 we have done target discovery. We have selected the [indiscernible] 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 the clinical sites, ensuring that we have a setup for testing the EVX-04 molecule. We plan to take this program into the clinic, but we are, of course, always interested and are engaging with companies.

So yes, yes, but it's not necessarily dependent on us entering into a partnership...

Helen Tayton-Martin

And all of those activities are going and on track. So definitely in terms of clinical sites, protocol development, GMP production, compiling the necessary regulatory documentation. So that contributes to our time frame that publicly. So no change or no concern at the moment. We know with all those activities and on track with the communicated time lines of regulatory filings by the end of the year.

Swayampakula Ramakanth

I've got a couple more questions. One for Helen. So you -- it's -- you previously even the previous management have been kind of talking about potential partnerships over 2 quarters now. At this point, what can you tell us in terms of where some of these discussions are and if you would like to characterize the stage of the most advanced ones? Where are they at? Are they like the due diligence part, exploratory part or you're almost in the hands of the [indiscernible] and waiting for them to get things put into print?

Helen Tayton-Martin

Sure. That's an obvious -- it's a good question, okay, but 1 I can't really answer as transparent as you would like. I would say in the -- in our oncology conversations, obviously, clinical data that we have that begins talked about, particularly EVX-01 has been very meaningful. But I think the to some extent, the validation of the whole field in terms of having -- 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 sort of wait to see how the field pans out. And I think, hence, Birgitte's comments earlier about the positive endorsement of this provides for all of us who have 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 the novelty around the IRF platform, the ability to find the conserved antigens from the dark genome has also peaked quite a bit of interest.

Coming in with the second program there in a highly very difficult to treat brain cancer 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 2 years. So I would say that we have active conversations. And obviously, we'll be very happy to update when we can.

Swayampakula Ramakanth

One last question from me. So Thomas, when we look at your operations in the first half, the cash use was about $80 million, and 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 -- 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

Yes. No, good. Thanks, RK. So maybe the first part of your question. So our cash or 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 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 has have seen in -- on the bank account. Please also do remember, of course, that there are some normal fluctuates based on where predominantly DKK based company versus U.S. So there are some fluctuations from a pure ForEx perspective into that also. On top of that, -- so 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 paying into the plan in terms of how we communicated half 2 '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 ASM 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 possibility 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.

Operator

And this question comes from Debanjana Chatterjee from Jones.

Unknown Analyst

This is [indiscernible] on for Debanjana. We had a few questions as well. So the first 1 that we wanted to ask was which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine that you are developing?

Birgitte Rono

Specify the specific popular. We are still working on identifying our we're still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most all set up the most optimal patient population. And further, we are, of course, also looking into standard of care and combination therapies, 1 to be a little bit cautious on combining a vaccine with chemotherapy of the main option of going into those patients that are not benefiting from chemotherapy treatments. But we haven't entirely send on the specifics around the clinical [indiscernible].

Unknown Analyst

Okay. And then as a quick follow-up, so what should we expect as the time line 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

Yes. So we are early in the preclinical development. We've concluded on target discovery. So we're using our AI immunology for mining, the patient data and now have a set of optimal that will be included in the EVX-05 vaccine. So we are screening, we have designed several different vaccine candidates are now experimentally assisting those to select the lead candidates. And then it's the classical activities, activities prior to the first-in-human study.

And as mentioned, we are working together with Duke University. We haven't communicated any firm time lines on this program as we need, we need to see, first of all, the selection before we start communicating time lines.

Helen Tayton-Martin

[indiscernible] platform for EVX-04 in terms of delivery methodology, which definitely will we use the expertise and experience there for some of the GMP production side of things. So more to come on the time, 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 EVX-04.

Unknown Analyst

And then as a final question, so beyond glioblastoma, how broadly applicable do you believe the ERB targeting approach could be across various solid tumors. And then broadly, how does the EVX-05 fit into the long-term strategy of building that AI-driven oncology franchise?

Birgitte Rono

Yes. So we have worked a lot in using immunology to mine patient data across the different indications. And we do see that there are certain patient types where they have a bad 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

And I think what's interesting is that often where not a high mutational burden. I think that there often is a high 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 ERFs more to come on that as we've been teething this part. So we think it really does broaden out the opportunity in terms of what we -- the counter vaccine reach for novel targets.

Operator

[Operator Instructions] There seems to be no further questions for today, so I will hand the call back to Helen for closing remarks.

Helen Tayton-Martin

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 but the interest in the programs coming in on the back of a really exciting times 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

Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect.