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에바시온(EVAX) 2026년 2분기 실적 발표회: 현금 1,400만 달러 및 EVX-01 업데이트

TradingKeyAug 20, 2026 8:03 PM
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이백시온(Evaxion)은 2026년 2분기 말 1,400만 달러의 현금을 보유했으며, 해당 자금으로 2027년 하반기까지 운영을 지원할 수 있을 것으로 예상한다. 2분기 순손실은 370만 달러를 기록했다.

진행성 흑색종 대상 EVX-01 임상 2상의 3년 효능 데이터는 2026년 10월 ESMO에서 발표될 예정이다. 교모세포종 대상 EVX-05는 16개의 백신 후보물질이 선정되었으나 최초 인체 임상 일정은 아직 수립되지 않았다.

EVX-04는 2026년 말까지 규제당국 제출을 목표로 관련 절차가 진행 중이다. 경영진은 파트너십 논의가 활발히 진행 중이나 거래 시기와 확실성에 대해서는 언급하지 않았다.

AI 생성 요약

핵심 요약

  • 이백시온(Evaxion)은 2026년 2분기 말 1,400만 달러의 현금을 보유했으며, 경영진은 해당 자금으로 운영을 지원할 수 있는 기간을 2027년 하반기까지로 재확인했습니다.
  • 회사는 2분기 순손실 370만 달러를 기록했다고 발표했습니다. 일반관리비 및 자본시장 관련 비용 감소가 연구개발비의 소폭 증가를 상쇄하면서 영업비용은 전년 동기 대비 감소했습니다.
  • 이백시온은 2026년 10월 ESMO에서 진행성 흑색종 대상 EVX-01 임상 2상의 3년 효능 데이터를 발표할 계획이며, 여기에는 임상적 반응 및 T세포 반응의 지속성이 포함됩니다.
  • 이전에 발표된 EVX-01 데이터에서는 2년 시점 전체 반응률이 75%로 나타났으며, 반응을 보인 환자의 92%가 여전히 반응을 유지했습니다. AACR에서는 백신 표적의 86%가 종양 특이적 면역 반응을 유도한 것으로 나타났습니다.
  • 교모세포종 후보물질인 EVX-05의 경우, 회사는 약 150만 개의 내인성 레트로바이러스 유래 단편을 스크리닝하여 백신 설계를 위해 16개를 선정했습니다. 최초 인체 임상 일정은 아직 수립되지 않았습니다.
  • EVX-04는 GMP 제조, 임상시험 기관 준비 및 기타 IND 신청 지원 작업이 진행 중이며, 경영진에 따르면 2026년 말까지 규제당국 제출을 완료한다는 계획을 차질 없이 추진하고 있습니다.

주요 재무 데이터

지표2026년 2분기변동 내용 및 배경
순손실370만 달러경영진은 실적이 내부 재무 계획에 부합한다고 밝혔습니다.
분기말 현금1,400만 달러2027년 하반기까지 운영을 지원할 것으로 예상됨
분기말 자본950만 달러상반기 순손익 결과 반영
영업비용수치 미기재주로 일반관리비 및 자본시장 관련 비용 절감에 따라 전년 동기 대비 감소
연구개발비(R&D)수치 미기재EVX-01, EVX-04, EVX-05 개발 진전에 따라 전년 동기 대비 소폭 증가

사업 및 운영 성과

EVX-01: 10월 예정된 흑색종 3년 데이터

EVX-01은 진행성 흑색종 치료를 위해 임상 2상 개발 중인 이백시온의 맞춤형 신생항원 암 백신입니다. 10월 ESMO 발표에서는 단독 요법 및 항 PD-1 치료제와의 병용 요법으로서의 효능을 평가할 예정입니다.

경영진은 이전에 발표된 전체 반응률을 유지하거나 개선하고, 2년 시점에 관찰된 반응을 지속하며, 지속적인 T세포 활성을 입증하는 것을 긍정적인 결과의 기준으로 꼽았습니다.

이전에 공개된 2상 결과에 따르면 2년 시점의 전체 반응률은 75%였으며, 반응을 보인 환자의 92%가 반응을 유지했습니다. 환자의 절반 이상이 EVX-01 치료 중 임상적 반응이 개선되었습니다. 별도의 AACR 데이터에서는 EVX-01 백신 표적의 86%가 종양 특이적 면역 반응을 유도했으며, 면역원성 표적의 86%가 새로운 T세포 반응을 생성한 것으로 나타났습니다.

또한 경영진은 모더나(Moderna)와 머크(Merck)의 맞춤형 암 백신 프로그램에서 나온 긍정적인 3상 결과가 이러한 치료 접근법의 광범위한 타당성을 입증하며, 파트너십 논의를 강화하는 데 도움이 될 수 있다고 언급했습니다.

EVX-05, 기성품(Off-the-shelf) 암 백신 파이프라인 확장

EVX-05는 듀크 대학교와 함께 개발 중인 교모세포종 대상 기성품(off-the-shelf) 백신 후보물질입니다. 이백시온의 AI-Immunology 플랫폼을 활용하여 다크 게놈의 내인성 레트로바이러스 요인에서 유래한 보존된 종양 특이적 항원을 발굴합니다.

회사는 환자의 시퀀싱 데이터를 마이닝하여 약 150만 개의 단편을 식별하고, EVX-05 설계에 포함할 16개를 선정했습니다. 현재 선도물질 선정 및 IND 신청 준비 작업에 앞서 여러 백신 후보물질을 대상으로 실험적 검증을 진행하고 있습니다.

이백시온은 최초 인체 투여 임상시험 일정을 확정하지 않았습니다. 또한 환자 하위 집단, 항원 프로필 및 잠재적 병용 치료 조합에 대해 계속 평가 중입니다.

EVX-04, 규제당국 신청을 향한 진전

EVX-04는 급성 골수성 백혈병 환자 검체에서 발견된 보존 항원을 표적으로 하는 기성품 암 백신 프로그램입니다. 유럽혈액학회(EHA) 학술대회에서 발표된 데이터에 따르면 16개 표적이 다양한 HLA 유형에 걸쳐 인간 면역세포를 활성화하고 표적 세포 사멸을 지원하는 것으로 나타났습니다.

이 프로그램은 현재 IND 승인을 위한 개발 단계에 있습니다. 현재 작업에는 GMP 제조, 면역 반응 검사, 임상시험 계획서 작성, 임상시험 기관 확보 및 규제 문서 준비가 포함됩니다. 경영진은 2026년 말까지 신청을 완료하겠다는 목표를 유지했습니다.

EVX-D1, 추가 전임상 CMV 데이터 확보

7월 국제 헤르페스바이러스 워크숍에서 이백시온은 AI-Immunology로 발굴한 에피토프가 급성 거대세포바이러스(CMV) 감염, 잠복기 및 재활성화를 제어하는 데 도움이 될 수 있음을 보여주는 마우스(쥐) 데이터를 발표했습니다. 이 연구 결과는 광범위한 방어 효과를 가진 EVX-D1 백신 후보물질의 항원 선정에 활용될 예정입니다.

경영진 가이던스

이백시온은 기존 자원으로 2027년 하반기까지 우선순위 사업 운영 자금을 충당할 수 있을 것이라는 점을 재확인했습니다. 이 자금 조달 기간(runway)에는 EVX-01, EVX-04, EVX-05 관련 예정된 개발 작업이 포함됩니다.

경영진은 또한 다음과 같은 예상 마일스톤을 제시했습니다.

  • 2026년 10월 ESMO에서 EVX-01 임상 2상 3년 효능 데이터 발표
  • 2026년 중 자가면역질환 분야에서 AI-Immunology 활용에 관한 추가 정보 공개
  • 2026년 말까지 EVX-04 규제당국 제출 계획
  • 구체적인 임상 일정 없이 EVX-05 전임상 선도물질 선정 작업 지속

리스크 및 주시해야 할 사항

  • EVX-05는 아직 초기 전임상 개발 단계에 있으며, 회사는 선도물질, 표적 환자군, 최초 인체 투여 임상 일정을 확정하지 못했습니다.
  • EVX-01 투자 포인트는 3년 데이터가 지속적인 임상 반응과 유지되는 T세포 활성을 입증할 수 있는지 여부에 부분적으로 달려 있습니다.
  • 파트너십 논의는 계속 활발히 진행 중이지만, 경영진은 거래 시기나 확실성에 대해서는 제시하지 않았습니다.
  • 경영진에 따르면 분기별 현금 사용량은 변동될 수 있으므로 단순 선형으로 추정해서는 안 됩니다. 덴마크 크로네와 미국 달러 환율 변동 역시 재무제표상 현금 보유액에 영향을 줄 수 있습니다.
  • 이백시온은 스탠딩 에쿼티(ATM) 조달 시설을 보유하고 있으며 최근 이 시설의 일부를 실행했다고 밝혔습니다. 향후 파트너십을 통해 추가 자금을 확보할 수 있지만, 이번 실적 발표 전화회의에서는 확정된 거래가 발표되지 않았습니다.

애널리스트 Q&A 주요 내용

EVX-05의 향후 단계는 무엇인가요?
경영진은 표적 발굴이 완료되었다고 밝혔습니다. 이백시온은 선도물질을 선정하기에 앞서 여러 백신 설계를 실험적으로 검증하고 있으며, 이후 표준 IND 승인 준비 절차를 진행할 예정입니다. 선도물질 선정이 진행되기 전까지 확정된 임상 일정은 발표되지 않을 것입니다.

의미 있는 EVX-01 3년 데이터의 기준은 무엇인가요?
경영진은 전체 반응률의 유지 또는 개선, 2년 시점 반응 환자들의 지속적인 반응 관찰, 백신 유도 T세포 반응의 지속성을 확인할 계획입니다.

EVX-04가 임상 개발 단계에 진입하기까지 남은 과제는 무엇인가요?
주요 작업에는 GMP 제조, 면역 활성 확인, 임상시험 기관 준비, 임상시험 계획서 작성 및 규제 서류 완성이 포함됩니다. 경영진은 이러한 작업이 연말 제출 목표에 맞춰 차질 없이 진행 중이라고 밝혔습니다.

파트너십 논의는 얼마나 진전되었나요?
경영진은 대화와 실사가 다양한 수준에서 활발히 진행 중이라고 설명했으나, 가장 진전된 논의의 성격을 구체화하거나 거래 일정을 제공하는 것은 사양했습니다.

회사는 현금 조달 가능 기간(Runway) 추정을 어떻게 뒷받침하나요?
경영진은 분기별 지출이 일률적이지 않다고 언급하며 우선순위 프로그램에 집중하고 있음을 재확인했습니다. 회사는 ATM 시설을 활용할 수 있으며, 향후 파트너십 유입금 또한 가용 자원에 추가될 수 있습니다.

실적 발표 전화회의 전문


전체 실적 발표 컨퍼런스 콜 녹취록

경영진 발표

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.

질의응답

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.

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