Evaxion (EVAX) 2026 年第二季法說會:1,400 萬美元現金與 EVX-01 最新進展
Evaxion第二季淨虧損370萬美元,季末現金140萬美元,可支持營運至2027年下半年。焦點項目EVX-01晚期黑色素瘤二期三年數據將於10月ESMO大會公布;EVX-04預計2026年底前提出法規申報;EVX-05則持續進行前臨床篩選與IND準備,尚無明確臨床時間表。
重點摘要
- Evaxion 在 2026 年第二季末擁有 1,400 萬美元現金, 管理階層重申,現有資金預計可支持營運至 2027 年下半年。
- 該公司公布 第二季淨虧損為 370 萬美元。 營運費用同比下降,主要由於一般及行政費用 (G&A) 以及資本市場成本減少,抵銷了研發費用的微幅增加。
- Evaxion 計劃於 2026 年 10 月的 ESMO 大會上,公布 EVX-01 用於晚期黑色素瘤的二期臨床試驗三年療效數據,包含臨床反應與 T 細胞反應的持久性。
- 先前公布的 EVX-01 數據顯示,兩年整體反應率為 75%,且 92% 產生反應的患者仍持續有效。在 AACR 年會上,86% 的疫苗標的誘發了腫瘤特異性免疫反應。
- 針對治療膠質母細胞瘤的候選疫苗 EVX-05,該公司篩選了約 150 萬個內源性逆轉錄病毒衍生片段,並選出 16 個用於疫苗設計。目前尚未確定首次人體試驗的時間表。
- EVX-04 仍按計劃推進,管理階層預計將於 2026 年底前提出法規申報,目前 GMP 製造、臨床試驗機構準備及其他 IND 申報準備工作正在進行中。
核心財務數據
| 指標 | 2026 年第二季 | 變動或背景資訊 |
|---|---|---|
| 淨虧損 | 370 萬美元 | 管理階層表示,業績符合其內部財務計劃 |
| 季末現金 | 1,400 萬美元 | 預計可支持營運至 2027 年下半年 |
| 季末權益 | 950 萬美元 | 反映上半年淨業績 |
| 營運費用 | 未提供具體數字 | 同比下降,主要歸因於一般及行政費用與資本市場成本減少 |
| 研發費用 | 未提供具體數字 | 隨著 EVX-01、EVX-04 和 EVX-05 的推進,同比微幅增加 |
業務與營運表現
EVX-01: 黑色素瘤三年數據預計於 10 月公布
EVX-01 是 Evaxion 開發的個人化新抗原癌症疫苗,目前正處於治療晚期黑色素瘤的二期臨床開發階段。10 月於 ESMO 發布的最新數據將評估該疫苗作為單一療法以及與抗 PD-1 療法聯合使用的療效。
管理階層表示,正面的結果將包括維持或改善先前公布的整體反應率、維持兩年時觀察到的反應,並展示持續的 T 細胞活性。
先前公布的二期臨床結果顯示,兩年整體反應率為 75%,且 92% 產生反應的患者仍持續有效。超過半數的患者在接受 EVX-01 治療期間臨床反應有所改善。另一份 AACR 數據顯示,86% 的 EVX-01 疫苗標的引發了腫瘤特異性免疫反應,同時 86% 的免疫原性標的產生了新型 T 細胞反應。
管理階層還表示,Moderna 與默沙東 (Merck) 個人化癌症疫苗計畫正面的三期臨床結果,有助於進一步驗證這種治療方法,並可能加強合作夥伴關係的討論。
EVX-05 拓展通用型腫瘤產品線
EVX-05 是與杜克大學 (Duke University) 合作開發的通用型膠質母細胞瘤候選疫苗。該疫苗利用 Evaxion 的 AI-Immunology 平台,從基因組暗物質中的內源性逆轉錄病毒元件中,識別出保守的腫瘤特異性抗原。
該公司挖掘了患者的基因定序數據,識別出約 150 萬個片段,並選擇了 16 個用於 EVX-05 的設計。目前多款候選疫苗正進行實驗測試,之後將進行主導候選藥物選定及 IND 申報準備工作。
Evaxion 尚未設定首次人體試驗的時間表。該公司目前也在評估患者亞群、抗原譜和潛在的聯合治療方案。
EVX-04 推進至法規申報階段
EVX-04 是一項通用型癌症疫苗計畫,針對在急性骨髓性白血病患者樣本中識別出的保守抗原。在歐洲血液學協會 (EHA) 大會上公布的數據顯示,其 16 個標的激活了跨不同 HLA 類型的人體免疫細胞,並支持標靶細胞殺傷作用。
該計畫目前處於 IND 申報準備階段。當前工作包括 GMP 製造、免疫反應測試、臨床試驗方案制定、試驗機構對接及法規文件準備。管理階層維持在 2026 年底前提交申報的目標。
EVX-D1 產生額外前臨床 CMV 數據
在 7 月舉行的國際皰疹病毒研討會上,Evaxion 公布的小鼠數據顯示,利用 AI-Immunology 發現的表位有助於控制急性巨細胞病毒 (CMV) 感染、潛伏與復發。這些發現將支持廣效保護性 EVX-D1 候選疫苗的抗原篩選。
管理階層指引
Evaxion 重申,現有資源預計可支持優先營運項目至 2027 年下半年。該資金延續期包含了 EVX-01、EVX-04 及 EVX-05 的預定計畫工作。
管理階層亦列出了以下預期的里程碑:
- 於 2026 年 10 月 ESMO 公布 EVX-01 二期臨床試驗三年療效數據。
- 於 2026 年期間進一步揭露 AI-Immunology 在自體免疫疾病中的應用。
- 預計於 2026 年底前提出 EVX-04 法規申報。
- 繼續進行 EVX-05 的前臨床主導候選藥物篩選工作,尚無確切的臨床時間表。
風險與關注領域
- EVX-05 仍處於早期前臨床開發階段,公司尚未確定主導候選藥物、目標患者群體或首次人體試驗時間表。
- EVX-01 的投資論點部分取決於三年數據是否能證實持久的臨床反應與持續的 T 細胞活性。
- 合作夥伴關係的討論仍持續進行中,但管理階層未提供任何交易的時間表或確定性。
- 管理階層表示,每季現金消耗量可能會有所波動,不應進行線性推算。丹麥克朗與美元之間的匯率波動亦可能影響報告中的現金數額。
- Evaxion 擁有按市價發行 (ATM) 的股權融資工具,並表示最近已啟用該工具的一部分。未來的合作夥伴關係可能提供額外資金,但法說會上並未宣布任何交易。
分析師問答集錦
EVX-05 的下一步為何?
管理階層表示標的發現已完成。Evaxion 正對幾種疫苗設計進行實驗測試,隨後選定主導候選藥物,接著進行標準 IND 申報準備工作。在主導藥物選定取得進展之前,不會發布確切的臨床時間表。
何種 EVX-01 三年數據才具有實質意義?
管理階層期待看到整體反應率保持穩定或提升、兩年時產生反應的患者持續保持療效,以及疫苗誘發之 T 細胞反應的維持。
在 EVX-04 進入臨床開發前還需完成哪些工作?
主要工作包括 GMP 製造、免疫活性確認、臨床試驗機構準備、方案制定及完成法規申報文件。管理階層表示,這些工作仍按進度推進,目標在年底前提出申報。
合作夥伴關係的討論進展如何?
管理階層將討論描述為積極推進,並涉及不同層面的對話與盡職調查,但拒絕具體說明進展最深的討論狀況或提供交易時間表。
該公司如何支持其現金可維持時間的估計?
管理階層表示支出並非按季度線性分布,並重申重點放在優先計畫上。公司亦可能利用其 ATM 融資工具,而未來任何合作夥伴關係的收益都將增加可用資源。
完整財報電話會議記錄
完整財報電話會議逐字稿
管理層陳述
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.
分析師問答
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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