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EVAX

Evaxion A/SC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-20
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Earnings documents stored for EVAX.

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Investor releaseQuarter not tagged2026-08-20

Evaxion AS (EVAX) (Q2 2026) Earnings Call Highlights: Strong EVX-01 Data and Field Validation ...

GuruFocus.com
This article first appeared on GuruFocus. Net Loss: Reported net loss of $3.7 million for Q2 2026. Cash Position: Cash at end of Q2 2026 was $14 million. Equity: Equity at end of Q2 2026 was $9.5 million. Operating Expenses: Slightly reduced overall, driven by lower general and administration costs, particularly capital market costs. R&D Expenses: Slight increase versus last year, aligned with progress on EVX-01, EVX-04, and EVX-05 programs. Cash Runway: Confirmed to fund operations into the second half of 2027. Warning! GuruFocus has detected 2 Warning Signs with EVAX. Is EVAX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Evaxion AS (NASDAQ:EVAX) reported strong clinical data for its lead asset EVX-01, with 86% of vaccine targets triggering tumor-specific immune responses and a 75% overall response rate in advanced melanoma patients, including durable responses at the two-year mark. The positive Phase III results from Moderna and Merck's personalized cancer vaccine program validate the entire field, including Evaxion AS (NASDAQ:EVAX)'s EVX-01 approach, strengthening its position for potential partnerships and regulatory pathways. Evaxion AS (NASDAQ:EVAX) expanded its pipeline with the new EVX-05 program for glioblastoma, leveraging its AI immunology platform to identify conserved antigens from endogenous retroviruses, addressing a significant unmet medical need in a hard-to-treat cancer. The company presented promising preclinical data for its EVX-04 off-the-shelf vaccine in AML, demonstrating that vaccine targets can activate human immune cells across different HLA types and mediate targeted cell killing, supporting its potential as an effective therapeutic vaccine. Evaxion AS (NASDAQ:EVAX) maintained a disciplined financial approach, with a cash runway extending into the second half of 2027, and reported a net loss of $3.7 million for Q2 2026, in line with its financial plan. The AI immunology platform received a second Gallian award, recognizing its value in predicting immune responses across oncology, infectious disease, and autoimmune disease programs, enhancing the company's credibility and business development prospects. Evaxion AS (NASDAQ:EVAX) reported a net loss of $3.7 million for Q2 2026, with R&D exp…Read full document

This article first appeared on GuruFocus. Net Loss: Reported net loss of $3.7 million for Q2 2026. Cash Position: Cash at end of Q2 2026 was $14 million. Equity: Equity at end of Q2 2026 was $9.5 million. Operating Expenses: Slightly reduced overall, driven by lower general and administration costs, particularly capital market costs. R&D Expenses: Slight increase versus last year, aligned with progress on EVX-01, EVX-04, and EVX-05 programs. Cash Runway: Confirmed to fund operations into the second half of 2027. Warning! GuruFocus has detected 2 Warning Signs with EVAX. Is EVAX fairly valued? Test your thesis with our free DCF calculator. Release Date: August 20, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Evaxion AS (NASDAQ:EVAX) reported strong clinical data for its lead asset EVX-01, with 86% of vaccine targets triggering tumor-specific immune responses and a 75% overall response rate in advanced melanoma patients, including durable responses at the two-year mark. The positive Phase III results from Moderna and Merck's personalized cancer vaccine program validate the entire field, including Evaxion AS (NASDAQ:EVAX)'s EVX-01 approach, strengthening its position for potential partnerships and regulatory pathways. Evaxion AS (NASDAQ:EVAX) expanded its pipeline with the new EVX-05 program for glioblastoma, leveraging its AI immunology platform to identify conserved antigens from endogenous retroviruses, addressing a significant unmet medical need in a hard-to-treat cancer. The company presented promising preclinical data for its EVX-04 off-the-shelf vaccine in AML, demonstrating that vaccine targets can activate human immune cells across different HLA types and mediate targeted cell killing, supporting its potential as an effective therapeutic vaccine. Evaxion AS (NASDAQ:EVAX) maintained a disciplined financial approach, with a cash runway extending into the second half of 2027, and reported a net loss of $3.7 million for Q2 2026, in line with its financial plan. The AI immunology platform received a second Gallian award, recognizing its value in predicting immune responses across oncology, infectious disease, and autoimmune disease programs, enhancing the company's credibility and business development prospects. Evaxion AS (NASDAQ:EVAX) reported a net loss of $3.7 million for Q2 2026, with R&D expenses slightly increasing year-over-year due to progress across multiple programs, indicating ongoing cash burn. The company's cash position at the end of Q2 2026 was $14 million, and while the runway extends into the second half of 2027, it may require additional capital through ATM facilities or partnerships to sustain operations beyond that period. Evaxion AS (NASDAQ:EVAX) has not provided firm timelines for the EVX-05 glioblastoma program, as it is still in early preclinical development, with lead candidate selection and IND-enabling activities yet to be completed. The company's business development discussions have been ongoing for multiple quarters without announced partnerships, and management noted that some dialogues have been in a 'wait and see' mode pending field validation, creating uncertainty around near-term deal closures. Evaxion AS (NASDAQ:EVAX) faces competition from larger players like Moderna and Merck, which have advanced personalized cancer vaccines to Phase III, potentially overshadowing Evaxion's earlier-stage programs and making it harder to attract partners or investors. The EVX-05 program relies on the novel ERV-targeting approach, which is still unproven clinically, and the company has not yet identified the specific patient population most likely to benefit, adding development risk. Q: What would you consider a clinically meaningful durability result for the three-year EVX-01 extension data at ESMO, especially in the stand-alone vaccine arm, and how would that help partnership discussions?A: Birgitte Rono, Chief Scientific Officer, stated that positive data would show a maintained or improved overall response rate and durable T-cell responses, with the same number of patients remaining in response as at the two-year mark. She emphasized that this is a high unmet need area, as nearly half of advanced melanoma patients on checkpoint inhibitors alone experience disease progression by five years. She added that the recent positive Phase III data from Moderna and Merck validates the entire personalized cancer vaccine field, which is highly supportive of ongoing partnership discussions. Q: Can you elaborate on the specific role Duke University played in the EVX-05 development and when we might expect more news from the program?A: Birgitte Rono, Chief Scientific Officer, explained that the collaboration with Duke University has been ongoing, providing access to extensive sequencing data from their patient clinics. Evaxion used this data to identify conserved antigens for an off-the-shelf vaccine approach. The company has concluded target discovery and is now selecting lead candidates from several designed vaccine candidates undergoing experimental testing. While a firm timeline hasn't been set, the next steps include IND-enabling activities and a first-in-human study. Q: Regarding the off-the-shelf molecule EVX-04, what are the gating steps to get it ready for the clinic?A: Birgitte Rono, Chief Scientific Officer, confirmed that target discovery is complete and the company is now conducting IND-enabling activities, including GMP manufacturing and verifying the molecule's ability to drive a strong immune response. Helen Tayton-Martin, CEO, added that all activities, including clinical site engagement, protocol development, and regulatory documentation, are on track to meet the communicated timeline of regulatory filing by the end of the year. Q: Can you characterize the stage of the most advanced partnership discussions? Are they in due diligence or exploratory?A: Helen Tayton-Martin, CEO, stated she couldn't be fully transparent but noted that the recent field validation from Moderna and Merck has had a significant impact. She indicated that while various levels of dialogue and diligence are ongoing, the positive endorsement of the field provides momentum. She also highlighted that the novelty of the ERV platform and its application to difficult-to-treat cancers like glioblastoma has generated significant interest, noting that BD processes can move quickly or take up to two years. Q: With a cash position of $14 million and a quarterly burn rate of about $4 million, how do you plan to fund operations into the second half of 2027?A: Thomas Schmidt, CFO, clarified that cash out is not linear and the $14 million figure is not a round number, with expectations to be slightly lower. He confirmed the runway into the second half of 2027 is maintained through disciplined resource allocation. He also noted the company has an ATM facility, which was partially activated as of yesterday following positive news, and that future partnership deals would also add to the cash position. Q: Which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine?A: Birgitte Rono, Chief Scientific Officer, stated that the company is still working to identify the optimal patient population by analyzing different ERV profiles. They are also considering standard of care and combination therapies, potentially focusing on patients not benefiting from chemotherapy, but specifics on the clinical design have not yet been finalized. Q: What is the timeline for initiating the first-in-human trial for EVX-05, and what milestones should investors watch for?A: Birgitte Rono, Chief Scientific Officer, stated the program is early in preclinical development with target discovery concluded. Several vaccine candidates are being experimentally tested to select a lead. No firm timelines have been communicated until lead selection is complete. Helen Tayton-Martin, CEO, added that the company will leverage its experience from EVX-04 in GMP production and delivery methodology to accelerate the program. Q: Beyond glioblastoma, how broadly applicable is the ERV targeting approach across solid tumors, and how does EVX-05 fit into the long-term strategy?A: Birgitte Rono, Chief Scientific Officer, stated that AI immunology has been used to mine patient data across indications, and certain patient types have ERV antigens, making the approach scalable to other solid tumors and hematologic malignancies. Helen Tayton-Martin, CEO, added that this approach is particularly valuable in tumors with low mutational burden where personalized approaches aren't feasible, broadening the reach of the cancer vaccine franchise. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Investor releaseQuarter not tagged2026-08-20

Evaxion announces business update and second quarter 2026 financial results

GlobeNewswire
COPENHAGEN, Denmark, August 20, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces second quarter 2026 financial results. Business highlights (since last quarterly update)Evaxion is making steady progress towards completing its strategic milestones for 2026. Highlights include: Announcing the upcoming presentation of three-year clinical data for personalized cancer vaccine candidate EVX-01 at the ESMO Congress 2026 Presentation of new data for EVX-04, an off-the-shelf cancer vaccine for acute myeloid leukemia (AML) Expansion and refocusing of our R&D pipeline with EVX-05, a novel off-the-shelf therapeutic cancer vaccine program for glioblastoma Presentation of new data for cytomegalovirus (CMV) vaccine candidate EVX-V1 Winning the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology™ Cash runway unchanged with cash at hand to fund operations into the second half of 2027 “Progress remains strong in recent months, particularly regarding the expansion and progression of our R&D pipeline. Both EVX-04 and EVX-05 represent completely new concepts in targeting hard-to-treat cancers and are great examples of what we can do with AI-Immunology™ to identify novel, conserved cancer targets for off-the-shelf vaccines. The same is true for EVX-V1 in the infectious disease space and we are excited by the successful progress of this next-generation, multi-component CMV-vaccine program. These programs and the combined R&D pipeline show how our AI-Immunology™ platform can truly deliver product candidates, which is crucial in validating our platform and for partnerships,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcastEvaxion’s executive management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Research & Develop…Read full document

COPENHAGEN, Denmark, August 20, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces second quarter 2026 financial results. Business highlights (since last quarterly update)Evaxion is making steady progress towards completing its strategic milestones for 2026. Highlights include: Announcing the upcoming presentation of three-year clinical data for personalized cancer vaccine candidate EVX-01 at the ESMO Congress 2026 Presentation of new data for EVX-04, an off-the-shelf cancer vaccine for acute myeloid leukemia (AML) Expansion and refocusing of our R&D pipeline with EVX-05, a novel off-the-shelf therapeutic cancer vaccine program for glioblastoma Presentation of new data for cytomegalovirus (CMV) vaccine candidate EVX-V1 Winning the 2026 Prix Galien UK Award for Best digital health solution for AI-Immunology™ Cash runway unchanged with cash at hand to fund operations into the second half of 2027 “Progress remains strong in recent months, particularly regarding the expansion and progression of our R&D pipeline. Both EVX-04 and EVX-05 represent completely new concepts in targeting hard-to-treat cancers and are great examples of what we can do with AI-Immunology™ to identify novel, conserved cancer targets for off-the-shelf vaccines. The same is true for EVX-V1 in the infectious disease space and we are excited by the successful progress of this next-generation, multi-component CMV-vaccine program. These programs and the combined R&D pipeline show how our AI-Immunology™ platform can truly deliver product candidates, which is crucial in validating our platform and for partnerships,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcastEvaxion’s executive management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Research & Development (R&D) updateEvaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. In future, this is expected to be supplemented by programs for autoimmune diseases following application of AI-Immunology™ in this space in the second half of 2026. We are looking forward to presenting three-year clinical efficacy data for personalized cancer vaccine EVX-01, our most advanced pipeline asset, at the European Society for Medical Oncology (ESMO) Congress 2026 in October. Developed with AI-Immunology™, EVX-01 is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-year treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results presented at ESMO in 2025. Following on with a one-year extension of the phase 2 trial, the upcoming data will provide additional insights into potentially enhanced treatment effects and durability of the EVX-01-induced immune response. It will also offer insights into the vaccine’s effect also as stand-alone treatment of these patients with advanced melanoma, in comparison to the prior administration in combination with pembrolizumab in the first two years of the trial. In addition to the personalized approach, we are leveraging AI-Immunology™’s capabilities to develop novel off-the-shelf cancer vaccines, including EVX-04 targeting AML. Developed with AI-Immunology™, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. ERV antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines. AI-Immunology™ has unique capabilities in identifying ERVs and this opens a whole new source of antigens, which can potentially greatly improve patient outcomes. We are progressing preclinical activities with EVX-04 as planned and presented new data at the European Hematology Association (EHA) 2026 Congress. The data demonstrates EVX-04’s complete expression in human cells, including correct transcription and translation. Further, EVX-04 is secreted in human cells, enabling immune recognition and activation. The data also shows that all ERV antigens included in EVX-04 drive specific immune responses both in mice (in vivo) and human cells (in vitro) across different human immune profiles. These vaccine-induced immune cells mediate targeted cell-killing, highlighting EVX-04’s potential as a new effective therapeutic cancer vaccine. In parallel with preclinical studies, we are preparing the regulatory filing for clinical testing of EVX-04, which is expected to be submitted before the end of the year. We have also leveraged our capabilities to identify clinically relevant ERVs to expand our pipeline with EVX-05, a novel off-the-shelf cancer vaccine candidate for the deadly brain cancer glioblastoma. Partly based on data analysis done in collaboration with leading experts from Duke University School of Medicine, EVX-05 targets endogenous retrovirus (ERV)-derived antigens shared between glioblastoma patients. The use of such antigens could potentially be highly effective for glioblastoma patients, who generally have few neoantigens to target due to low mutational burden. We also carry out preclinical activities for infectious disease programs and presented new data for CMV vaccine program EVX-V1 at the International Herpesvirus Workshop 2026 in July. EVX-V1 is a next-generation, multi-component CMV vaccine program designed with AI-Immunology™. It combines novel AI-Immunology™ identified protective B-cell antigens and T-cell epitopes complemented by known optimized structural B-cell antigens. This broader multi-targeted strategy is expected to strengthen the protective potential of a future vaccine. The concept represents a scalable strategy for rational vaccine development across other herpesviruses. The new data demonstrates the potential to improve control of acute infection, latency, and viral reactivation, further supporting the concept behind EVX-V1. Business development updateWe remain active in several parallel partnership discussions based on external interest in both our AI-platform and R&D pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships. We were honored to receive the Prix Galien UK Award for Best digital health solution for AI-Immunology™ in June. The award is another strong external validation and recognition of the AI-Immunology™ platform and as such supporting our partnering efforts, alongside the new data we continuously generate to further validate the fact that AI-Immunology™ is a platform that deliver product candidates. This is an important proposition to potential business partners. Second quarter 2026 financial resultsThe financial results for the second quarter 2026 were in line with expectations with a net loss of $3.7 million, compared to $3.6 million in the first quarter 2026 and $4.8 million in the second quarter 2025. The reduced loss compared to same period last year primarily relates to lower capital market transaction costs and financial expenses from significantly reduced derivative liability. Research and development (R&D) expenses were $2.3 million for the second quarter 2026, aligned with first quarter 2026, and a slight increase compared to second quarter last year, as we progress our pipeline according to plan. General and administrative (G&A) expenses were $1.5 million for the quarter, which was at same level with first quarter 2026, and compared to $2.2 million in second quarter 2025. Compared to last year the reduced cost is primarily driven by lower capital market costs. Net financial expense of $0.1 million for the second quarter 2026 compared to net financial expense of $0.7 million same quarter last year, a reduction of net expense mainly due to reduced derivative liability and the thereof related remeasurement. Cash and cash equivalents as of June 30, 2026, were $14.0 million, compared to $18.4 million as of March 31, 2026, and confirm our current cash runway until second half of 2027. Total equity amounts to $9.5 million as of June 30, 2026, reflecting the net loss of the first six months of 2026 when compared to $17.0 million as of December 31, 2025. Evaxion A/S(Unaudited) Consolidated statement of financial position data(USD in thousands) Evaxion A/S(Unaudited) Consolidated statement of comprehensive loss data(USD in thousands, except per share data) Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

TranscriptFY2026 Q22026-08-20

FY2026 Q2 earnings call transcript

Earnings source - 73 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the Evaxion business update and second quarter 2026 financial results. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 and 1 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 1 and 1 again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Helen Tayton-Martin, CEO. Please go ahead.

Helen Tayton-Martin

Thank you, speaker. I'm Helen Tayton-Martin. I'm the Chief Executive of Evaxion, and we're delighted today to be presenting our Q2 business update. I'm joined today on the call by Birgitte Rønø, our CSO and COO, who will provide an overview of our updates in our R&D pipeline and AI-Immunology platform. Then I'll hand over to Thomas Schmidt, who will talk through our Q2 financial results before we bring it back to conclusions and Q&A. First, of course, we may make forward-looking statements, and the audience is advised to look at our recently filed SEC documents. Now I'll kick off the discussion. Really Q2 has been marked by a series of achievements in our four core areas or four core platforms for the company. First of all, just focusing on business development.

Helen Tayton-Martin

As previously and ongoing through the course of this year, there are many discussions we are having with partners regarding the Evaxion programs and pipeline. We've had a stream of very encouraging new data, which continues to come through and continuously validate the AI-Immunology platform, which really feeds into those various conversations, and we'll touch on some of those today. In particular, in our R&D area, we have been very pleased to be accepted to present further updates on our EVX-01 program, our personalized neoantigen cancer vaccine in advanced melanoma patients. Obviously, it was a great day for the field yesterday to see the positive phase III results from the similar Moderna Merck program in personalized cancer vaccine in melanoma produced.

Helen Tayton-Martin

It will be great for us and the field to talk more about that as we head into ESMO and an update on our own data there. Elsewhere, we have been working to refocus and expand the pipeline, leveraging our learnings with our EVX-03 and EVX-01 platform actually into a new program, which we call EVX-05 in glioblastoma, where we are further leveraging the ERVs that we have been able to identify, highly conserved ERV antigens for glioblastoma, building on what we have done in our EVX-04 program, using a similar approach to use AI-Immunology to find highly conserved and ERV antigens in AML. So we've presented new preclinical data on that earlier this year at the European Hematology Association annual conference, and we've also updated in our infectious disease portfolio on our EVX-V1 CMV program, too, at the recent International Herpesvirus Workshop last month.

Helen Tayton-Martin

More broadly on AI-Immunology, the platform itself, we were really delighted to see that recognized in the Prix Galien UK award, a second Prix Galien award we have had for the technology in the last 12 months. It is 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. Finally, in terms of the core of our updates, we have maintained a disciplined focus on our resource allocation, really strongly aligned to where we can build the most value from the platform. With that discipline, we can confirm that our cash runway remains unchanged with cash at hand to fund our operations into the second half of 2027, and Thomas will talk more about that.

Helen Tayton-Martin

Just a reminder before we jump into it, our pipeline consists of a number of programs in cancer and infectious disease at the current time. EVX-01 will be a focus for Birgitte's presentation in a few moments, and obviously also including our EVX-04 and EVX-05 programs, which are focused on the conserved ERV off-the-shelf antigen vaccines. In infectious diseases, we have a number of preclinical programs there, and some of which are partnered, one with Merck, one with Aprogen, and data is continuing to build around the interest that we have on those programs from partners.

Helen Tayton-Martin

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 and immunogenicity preclinical data alongside the clinical data from year 2 at ESMO last year. We have mentioned already, and we will be updating on the 3-year data from that program with efficacy results at ESMO in October. In the rest of the 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 off-the-shelf program in AML. Finally, we will have an update on our group A strep program with the design and preclinical validation of antigens and the EVX-04.

Helen Tayton-Martin

We continue to prosecute a partnership approach around these programs and platforms where we see value creation. With that, I will hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.

Birgitte Rønø

Thank you, Helen. Today, I will focus on our lead asset, EVX-01, our personalized neoantigen cancer vaccine currently in phase II in advanced melanoma. Then I will present our new off-the-shelf EVX-05 vaccine program, demonstrating the scalability of our AI-Immunology platform into the hard-to-treat and deadly brain cancer, glioblastoma. Lastly, I will showcase how AI-Immunology identified T cell epitopes are relevant in controlling CMV infections. As Helen mentioned, we will present three-year EVX-01 phase II outcome data at the ESMO Congress, in October. This data includes evaluation of the vaccine's effect as standalone and also in combination with anti-PD-1 treatment. The data will potentially give further insight into enhanced treatment effects, and also the durability of EVX-01-induced immune responses. Collectively, these data provide a more comprehensive assessment of the full potential of EVX-01 to strengthen the already strong clinical data package.

Birgitte Rønø

Looking back at previously announced data from the EVX-01 phase II trial, we reported strong EVX-01 induced immune activation at the AACR meeting in April. We were able to show that 86% of the EVX-01 vaccine targets 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 de novo T cell response, meaning that EVX-01 specifically triggers novel T cell responses rather than amplifying existing responses. This is very important, as induction of de novo T cell responses has been linked to clinical benefit. At the ESMO Congress last year, we reported two-year outcome data including a 75% overall response rate, 25% complete responses, and 92% of the patients still being in response, indicating durable clinical benefit.

Birgitte Rønø

Importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. Over the last approximately 10 years, personalized neoantigen vaccines has shown promise across several early-phase clinical studies. With the Moderna and Merck 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. These data are not just only a win for Moderna and Merck, but it is a win for the entire field as they broadly validate the personalized neoantigen vaccine concept. Overall, with our encouraging EVX-01 data and with the validation from Moderna and Merck, we believe that we are well-positioned as we move forward towards further value creation. Let us turn our focus to our off-the-shelf cancer vaccine programs.

Birgitte Rønø

In collaboration with Duke University, we are developing an off-the-shelf vaccine, EVX-05, for glioblastoma or GBM, targeting conserved antigens, as announced earlier this week. GBM is the most common and most aggressive primary malignant brain tumor. Despite surgery followed by chemoradiation, outcomes remain very poor, with a median overall survival of approximately one year, underscoring a significant unmet medical need. Our EVX-05 approach builds on the same novel and broadly applicable concept as EVX-04, as it is designed with AI-Immunology to target conserved tumor-specific antigens derived from endogenous retrovirus elements, or ERVs, which are part of the dark genome. The target selection process allows for broad tumor coverage despite immune and tumor ERV antigen differences across patients. We have applied AI-Immunology, our AI-powered target discovery approach, and identified an optimal set of ERV fragments, based on cross-patient relevance and immunogenic potential.

Birgitte Rønø

And we have mined patient sequencing data, identifying approximately 1.5 million ERV fragments and selected 16 of these as the fragments that will be included in the EVX-05 vaccine. Next steps include lead candidate selection and IND-enabling activities prior to a first-in-human study that is expected to be conducted in collaboration with the world-leading GBM experts we are collaborating with at Duke University. Our other off-the-shelf cancer vaccine program, EVX-04, is also progressing well. EVX-01 targets multiple conserved ERVs, in the case of this program, identified in AML patient samples. As Helen mentioned, we presented novel data at the European Hematology Association Congress in June, demonstrating that the EVX-04 vaccine is expressed and secreted by human cells, enabling immune recognition and activation.

Birgitte Rønø

Further, we showed that the 16 ERV targets included in the EVX-04 vaccine activate human immune cells across different HLA types, and that these ERV-reactive immune cells can mediate targeted cell killing, indicating not only immune recognition but also relevant functional impact of these vaccine-induced immune cells. Collectively, these data highlights EVX-04's potential as a new, effective therapeutic cancer vaccine, and we look forward to reporting further data as the program progresses towards regulatory filing later this year. Another promising program presented at a scientific conference during the summer is our EVX-V1 cytomegalovirus or CMV vaccine program. In EVX-V1, we are using AI-Immunology to design known targets, optimizing them, and also to identify previously unexplored vaccine targets.

Birgitte Rønø

At the International Herpesvirus Workshop in July, we presented new data demonstrating that T cell epitopes discovered with AI-Immunology have the potential to control acute infection, latency, and also reactivation in CMV-infected mice. This is a key finding as it complements previous results demonstrating the ability of both novel and optimized known B cell antigens to reduce viral infection. The data will guide antigen selection for a broadly protective CMV vaccine candidate and as such, represent a very important step forward for the EVX-V1 program. 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. AI-Immunology is clinically validated with positive outcome in 3 out of 3 oncology trials.

Birgitte Rønø

Preclinically, we demonstrated vaccine proof of concept across multiple disease areas, including cancer with our ERV-targeting vaccines, as well as in infectious diseases with several candidates against bacterial and viral pathogens. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors. Additionally, the novel ERV-based cancer vaccine concept is used in both our off-the-shelf programs, EVX-04 and EVX-05. Finally, AI-Immunology supports multiple modalities including peptides, recombinant proteins, DNA and RNA platforms, enabling both pipeline and partnering potential. In conclusion, we have demonstrated strong progress across our R&D pipeline, and we look forward to providing updates as our programs progress. With that, I will hand over to Thomas, who will present our quarterly financial results.

Thomas Schmidt

Perfect. Thank you, Birgitte. 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. 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.

Thomas Schmidt

Looking a little bit closer to our profit and loss statement for the quarter. Overall, we see a slightly reduced operating expenses, mainly driven from our general and administration costs, or the G&A costs, where we have significantly lower capital market costs in Q2 compared to the same period last year. On the R&D front, expenses do show a slight increase versus last year, but it's fully aligned with all the progress that Birgitte just mentioned on EVX-01, EVX-04, EVX-05. Again, also those programs are confirmed within our cash runway until the half year to 2027. We reported a net loss for the period of $3.7 million. Again, as mentioned already, on plan and following the execution that we've set for this year. Balance sheet, we have a cash position at the end of the quarter of DKK 14 million.

Thomas Schmidt

We are again reconfirming our cash runway, and the equity that we also have reflects the result for the first six months, meaning that we are at DKK 9.5 million at the end of the second quarter, reflecting that versus last year of the net result. All in all, a good financial performance aligned with expectation and certainly aligned with the progress of our platform and portfolio. With that, I hand it back to Helen for some concluding remarks.

Helen Tayton-Martin

Thanks, Thomas, and thanks, Birgitte. In conclusion, I would want to emphasize that we've seen some really good operational momentum on our set milestones and actually with a new program emerging with EVX-05 from all of our activities, but still maintaining our cash runway into the second half of 2027. We're really excited by the stream of new data that we've continued to generate with the team that continues to validate that AI-Immunology can deliver products, real meaningful products, for future development. 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. With that, we are very happy to take questions. Thank you for your attention.

Operator

Thank you. To ask a question, you will need to press star 1 and 1 on your telephone, and wait for your name to be announced. To withdraw your question, please press star 1 and 1 again. One moment for our first question. This question comes from Thomas Flaten from Lake Street Capital Markets. Please go ahead.

Thomas Flaten

Good morning, everybody. Just two 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. Then if you could elaborate a little bit on the specific role that Duke played in the development up to date.

Helen Tayton-Martin

Sure. Birgitte?

Birgitte Rønø

Yeah. The collaboration with Duke has been ongoing for quite some time. They do have a lot of sequencing data from the patients that they're treating in their clinic. We received sequencing data for some of those and were able to identify. First we did our personalized approach, looking into the profiles of the ERV and new antigen expression. Then as EVX-04 were in parallel progressing and this off-the-shelf concept were developing, we were able to use some of the same approaches, and analyze these samples for identifying conserved ERVs. We were very pleased to see that across these many patients, there were shared features indicating that we could definitely generate an off-the-shelf or design an off-the-shelf therapy. It's still, as I mentioned, a bit early in the development path.

Birgitte Rønø

We have conducted and concluded on what we would call target discovery, so selecting the targets that will be included in the vaccine, and we are now heading towards lead selection. We have designed several different candidates that are now being experimentally tested. Then it is the classical path with R&D enabling activities and then the first-in-human study. We have not yet settled entirely on a timeline for all of these activities, but that is what we are working on at the moment.

Helen Tayton-Martin

More to come.

Birgitte Rønø

More to come, definitely.

Helen Tayton-Martin

Thank you.

Birgitte Rønø

Yeah.

Operator

Thank you. We are now going to move to our next question, and this one comes from RK from H.C. Wainwright & Co. Please go ahead.

Swayampakula Ramakanth

Thank you. Good afternoon, Helen, Birgitte and Thomas. There are a few questions from me, but let me, hopefully, I could go one at a time. Starting off on EVX-01, obviously, it was exciting to see yesterday's news from the Merck Moderna collaboration, because it validates the program that you have been working on for a while now. Going into ESMO, for the three-year EVX-01 extension data, Birgitte, what would you consider a clinically meaningful durability result? Especially in the standalone vaccine period. 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 Rønø

Yeah. 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 rates. We should remember that these patients, advanced melanoma patients, if they only receive checkpoint inhibitors, then almost half of them by the five-year mark, are actually having a severe disease or even passed away. There is definitely a high unmet medical need for these patients. We would like to see that we have durable responses, so the same number of patients remains in response as at the two-year mark. Further, the T-cell responses are maintained. That is, we would consider that as positive data, positive outcome of this extension phase.

Swayampakula Ramakanth

Thank you.

Birgitte Rønø

And then you had an additional comment around how this data would potentially support partner-

Swayampakula Ramakanth

Yes

Birgitte Rønø

partnership discussions. Yes. So there's no doubt that the more positive data we can generate would be appreciated in these discussions. And I think the validation that came out yesterday of the personalized cancer vaccine concept definitely also is supportive or supports us in these discussions. We have been waiting, the whole field has been waiting for these phase III data for a long time. And it's not just a win for Moderna and Merck, but it's actually a win for the whole field. So definitely, we see this as very encouraging and positive and not just bad competitor news. It's very positive.

Swayampakula Ramakanth

Perfect. 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 will do the right thing when you start taking this into the clinic?

Birgitte Rønø

Yes. So EVX-04 is, we have done target discovery. We have selected the lead, and now we are conducting IND-enabling activities, so that includes the GMP manufacturing. And then, of course, we need to check that the molecule that is produced is also capable of driving a strong immune response. And then at the same time, we also engaging with clinical sites, ensuring that we have a setup for testing the 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.

Helen Tayton-Martin

Yeah.

Birgitte Rønø

It is not necessarily dependent on us entering into a partnership.

Helen Tayton-Martin

All of those activities are ongoing and on track.

Birgitte Rønø

Yeah.

Helen Tayton-Martin

I think in terms of clinical sites, protocol development, GMP production, compiling the necessary regulatory documentation, that contributes to our timeframe that we put out publicly. No change there, no concern at the moment with all those activities.

Birgitte Rønø

On track with the communicated timelines of regulatory filings by the end of the year.

Swayampakula Ramakanth

Oh, thank you. I got a couple more questions, one for Helen. You and even the previous management have been kind of talking about potential partnerships over a couple of quarters now.

Helen Tayton-Martin

Yeah.

Swayampakula Ramakanth

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 at the due diligence part, the exploratory part, or they're almost in the hands of the lawyers and waiting for them to get things put into print?

Helen Tayton-Martin

Sure. That's an obvious It's a good question, RK, but one I can't really answer as transparently as you would like. I would say in our oncology conversations, obviously clinical data that we have, that Birgitte's talked about, particularly EVX-01, has been very meaningful. But I think to some extent, the validation of the whole field in terms of seeing a company with a similar sort of program able to bring that forward to a registrational study has quite an impact. I think whilst we've been doing various levels of dialogue and diligence, things have been somewhat, there's sort of a wait to see how the field pans out. And I think hence Birgitte's comments earlier about the positive endorsement that this provides for all of us who think have programs that are actually quite differentiated in terms of what they can offer, and beyond melanoma as well.

Helen Tayton-Martin

In amongst all of that, I think that the novelty around the ERV platform, the ability to find the conserved antigens from the dark genome has also piqued quite a bit of interest. And coming in with a second program there in a very difficult to treat brain cancer accelerates that interest. 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 two years. I would say that we are in active conversations. And obviously we'll be very happy to update when we can.

Swayampakula Ramakanth

Thank you. One last question from me. Thomas, when we look at your operations in the first half, the cash use was about $8.3 million. It looks like your quarterly burn rate is about $4 million-plus. Against the DKK 14 million that you have in the bank now, can you walk us through your assumptions of how to get into second half 2027? Are you expecting cash infusion either organically or inorganically?

Thomas Schmidt

Yeah. No, good. Thanks, RK. Maybe first part of your question. Our cash out is not linear in the sense of each quarter just to extrapolate that. 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's at roughly DKK 14 million for the year. We might, and I would expect to be even slightly lower than that. It's not a round figure as such. We do have, of course, DKK 14 million, as you rightfully have seen on the bank account. Please also do remember, of course, that there are some normal fluctuations based on we're predominantly a DKK-based company versus the U.S.

Thomas Schmidt

There are some fluctuations from a pure Forex perspective into that also. On top of that, we still do expect that with the runway and with the focus on where we spend, how we spend, that we still, as mentioned earlier, can confirm that we are in the second half of 2027. We will, of course, utilize the different things that we have available to us. One is also, not that that has gone in, I should start saying, into the plan in terms of how we've communicated half to 2027, but we do have an ATM to facilitate that we can make use of. Actually, just as of yesterday, we also activated some of that ATM also in the market. Based, of course, on the positive news as we've seen and the volume in our price.

Thomas Schmidt

We will make use of those type of possibilities from an ATM perspective. Plus, of course, when we also, at a point in time, announce deals or partnerships, that will certainly also add to it. But with the current straight runway and with our prioritized programs, we are very confident that we will go and get into the second half of 2027.

Swayampakula Ramakanth

Thank you. Thank you all for taking all my questions.

Helen Tayton-Martin

Thank you.

Thomas Schmidt

Thank you.

Operator

Thank you. We are now going to take our next question. This question comes from Debanjana Chatterjee from JonesTrading. Please go ahead.

Speaker 6

Hi. Good morning, everyone. This is Avni on for Deepanjana. We had a few questions as well. The first one that we wanted to ask was, which glioblastoma patients are most likely to benefit from the EVX-05 cancer vaccine that you are developing?

Helen Tayton-Martin

We haven't specified a specific population.

Birgitte Rønø

We are still working on identifying or we're still looking into different patient subsets and looking at the different ERV profiles and seeing what would be the most optimal patient population. Further, we are, of course, also looking into standard of care and combination therapies. One should be a little bit cautious on combining a vaccine with chemotherapy. There might be an option of going into those patients that are not benefiting from classical chemotherapy treatments. But we haven't entirely settled on the specifics around the clinical trial design.

Speaker 6

Okay. As a quick follow-up, what should we expect as the timeline for initiating that first-in-human clinical trial? What are some key milestones that investors should be watching for before that trial initiates?

Birgitte Rønø

Yeah, so we are early in the preclinical development. We have concluded on target discovery, so using our AI-Immunology for mining the patient data and now have a set of optimal ERVs that will be included in the EVX-05 vaccine. We are screening. We have designed several different vaccine candidates, are now experimentally testing those to select the lead candidate. Then it is the classical R&D enabling activities prior to the first-in-human study. As mentioned, we are working together with Duke University. We have not communicated any firm timelines on this program, as we need to see, first of all, lead selection before we start communicating timelines.

Helen Tayton-Martin

We are leveraging the same platform for EVX-04 and EVX-05 in terms of delivery methodology.

Birgitte Rønø

Yes.

Helen Tayton-Martin

Which definitely will reuse the expertise and experience there from the GMP production side of things. More to come on the timelines, but certainly, there is a lot we know about how to bring this kind of platform forward, given the way we have done it already for EVX-04.

Speaker 6

No, thank you for that color. As a final question, beyond glioblastoma, how broadly applicable do you believe the ERV targeting approach could be across various solid tumors? Then broadly, how does the EVX-05 fit into the long-term strategy of building that AI-driven oncology franchise?

Birgitte Rønø

Yeah. We have worked a lot in using AI-Immunology to mine patient data across several different indications. We do see that there are certain patient subtypes where they have shared ERV antigens. There is definitely an option of applying this approach more broadly, but it is dependent on the profiles of those indications. But definitely more options for scaling this into other solid tumors and also hematologic malignancies.

Helen Tayton-Martin

I think what is interesting is that often where there is not a high mutational burden, there often is a high ERV frequency, and that is what we have been looking into. Often where there is not an opportunity to take a personalized approach forward because of low mutational burden, that does not seem to be the case with the ERVs. More to come on that as we have been teasing this apart. We think it really does broaden out the opportunity in terms of the cancer vaccine approach for novel targets.

Speaker 6

Thank you. Exciting times ahead. I appreciate you taking my questions.

Birgitte Rønø

Thank you.

Operator

Thank you. As a reminder, to ask a question, you will need to press star 1 and 1 on your telephone. That is star 1 and 1 to ask a question. There seems to be no further questions for today, so I will hand the call back to Helen for closing remarks.

Helen Tayton-Martin

Thank you. 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, about the interest in the programs coming in on the back of a really exciting time for personalized cancer vaccines in the whole field. So exciting things to come, and we look forward to updating you further in the second half of the year. Thank you.

Operator

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

Investor releaseQuarter not tagged2026-08-14

Evaxion to announce business update and second quarter 2026 financial results on August 20, 2026

GlobeNewswire
COPENHAGEN, Denmark, August 14, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its second quarter 2026 financial results on Thursday August 20, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development. We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “like…Read full document

COPENHAGEN, Denmark, August 14, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its second quarter 2026 financial results on Thursday August 20, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/SMads KronborgVice President, Investor Relations & Communication+45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development. We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Investor releaseQuarter not tagged2026-05-08

Evaxion (EVAX) Q1 2026 Earnings Transcript

Motley Fool
Image source: The Motley Fool. Thursday, May 7, 2026 at 8:30 a.m. ET Chief Executive Officer — Helen Tayton-Martin Chief Scientific Officer and Chief Operating Officer — Birgitte Rono Chief Financial Officer — Thomas Schmidt Head of Investor Relations and Communications — Mads Kronborg Need a quote from a Motley Fool analyst? Email [email protected] Helen Tayton-Martin: Thank you, and welcome, everyone, to Evaxion's Q1 2026 Business Update Call. I'm very pleased to be joined today by our CSO, Birgitte Rono and COO, recently promoted, we will talk more about that; and Thomas Schmidt, our CFO; and our Head of Investor Relations and Communications, Mads Kronborg. So if we move to the first slide, just to provide some orientation as to what we will cover today. We will spend a little bit of time on our achievements in the first quarter of this year and some notable changes that we have made in order to address and focus on our strategy. I will then hand over to Birgitte, who will talk through some of the recent highlights from our R&D portfolio and AI-Immunology platform. Birgitte will then hand over to Thomas, who will walk you through our Q1 financial results. And then we will have some concluding remarks before opening up the call for Q&A. So if I move to the next slide, just to reiterate, we may make some forward-looking statements on the call today, and investors and all listening are guided towards our SEC filed documents. So if I go past our introduction to Slide 5. I just wanted to, as before, emphasize our 4 key focus areas within the organization and give you a sense of the momentum as we perform an update in each of those areas. First of all, our core focus around business development and partnering is very much underway and strengthened. By the way, we have reorganized the organization somewhat, and I'll come on to that to focus on the external outreach and positioning of the company to a broader audience and also to raise the awareness of exactly what it is that Evaxion can deliver in terms of products and the platform. And I'm pleased to say that we have many discussions ongoing there, and we hope to report more on that later as the year progresses. Secondly, in our R&D focus areas, we are delighted to talk about our recent data from our EVX-01 lead program Phase II study in which we were able to update some of the translational data recently at AACR, an…Read full document

Image source: The Motley Fool. Thursday, May 7, 2026 at 8:30 a.m. ET Chief Executive Officer — Helen Tayton-Martin Chief Scientific Officer and Chief Operating Officer — Birgitte Rono Chief Financial Officer — Thomas Schmidt Head of Investor Relations and Communications — Mads Kronborg Need a quote from a Motley Fool analyst? Email [email protected] Helen Tayton-Martin: Thank you, and welcome, everyone, to Evaxion's Q1 2026 Business Update Call. I'm very pleased to be joined today by our CSO, Birgitte Rono and COO, recently promoted, we will talk more about that; and Thomas Schmidt, our CFO; and our Head of Investor Relations and Communications, Mads Kronborg. So if we move to the first slide, just to provide some orientation as to what we will cover today. We will spend a little bit of time on our achievements in the first quarter of this year and some notable changes that we have made in order to address and focus on our strategy. I will then hand over to Birgitte, who will talk through some of the recent highlights from our R&D portfolio and AI-Immunology platform. Birgitte will then hand over to Thomas, who will walk you through our Q1 financial results. And then we will have some concluding remarks before opening up the call for Q&A. So if I move to the next slide, just to reiterate, we may make some forward-looking statements on the call today, and investors and all listening are guided towards our SEC filed documents. So if I go past our introduction to Slide 5. I just wanted to, as before, emphasize our 4 key focus areas within the organization and give you a sense of the momentum as we perform an update in each of those areas. First of all, our core focus around business development and partnering is very much underway and strengthened. By the way, we have reorganized the organization somewhat, and I'll come on to that to focus on the external outreach and positioning of the company to a broader audience and also to raise the awareness of exactly what it is that Evaxion can deliver in terms of products and the platform. And I'm pleased to say that we have many discussions ongoing there, and we hope to report more on that later as the year progresses. Secondly, in our R&D focus areas, we are delighted to talk about our recent data from our EVX-01 lead program Phase II study in which we were able to update some of the translational data recently at AACR, and Birgitte will talk in more detail about the performance of the cells that we produce in relation to the vaccines given to the patients and the 86% immunogenicity conversion rate we have there. We also were able to present at AACR, a new set of data preclinically in collaboration with our collaborators at Duke University on the scope to use the AI-Immunology platform in glioblastoma. We have always felt that the approach could be applied to other high mutational burden tumors, but also to others where high mutational burden was not a feature, and that is very much part of how we were able to demonstrate the broader applicability of the platform in glioblastoma. And again, Birgitte will speak more to that. Finally, we were able to confirm the completion of the last patient, last visit in the extension phase of our EVX-01 program and our Phase II trial, and more to come on that later in the year. More broadly on the AI-Immunology platform, we continued to optimize and strengthen that around its ability to deliver products across our infectious diseases as well as oncology portfolio and again, also in autoimmune disease, again, where we'll update later in the year. But in this first quarter, I'm delighted to say that we were able to show some initial data on a new polio vaccine concept presented in collaboration with The Gates Foundation. And finally, as Thomas will come on to, we have maintained our disciplined allocation of resources aligned to our stated aims with the portfolio and the platform, and our cash runway remains unchanged into the second half of 2027. Moving to Slide 6. As mentioned, we have reorganized slightly inside the organization. I'm delighted to announce the promotion of Birgitte to the combined role of CSO and COO, which really reflects on how we organize the company and how well it's been run in recent times, but also to enable me, in particular, to have a greater focus externally on behalf of the company in terms of our business development and our investor interactions. Separately, and in parallel, we were able to welcome Jens Bitsch-Norhave to our Board of Directors. And Jens comes to us with a huge amount of experience in BD and corporate strategy and outreach in general, both from a biotech perspective but more recently from J&J and Hengrui, where he is currently Corporate VP and Global Head of Corporate Development. So we're delighted with the way that we've been able to strengthen the organization to focus on our stated strategy, to build and maintain what we have and build greater partnerships. So on Slide 7, just to summarize, we remain a lean and capable and focused team in terms of the management organization. Two of the members are here on the call with me today, and Andreas continues to support and drive the organization's innovation strategy around AI-Immunology. And our Board remains the same but with the addition of Jens, as I mentioned. Finally, moving to Slide 8 to set up our objectives and key milestones for this year. Just a reminder that Evaxion over many years now has the privilege of having a pipeline in Phase II in oncology with our EVX-01 asset in advanced melanoma, our personalized neoantigen-directed peptide-based vaccine, where we've got great data, which Birgitte will touch on in terms of now and what's to come. We have our EVX-03 program, which is a combination of personalized and IRF-based antigens on our DNA platform. And then we also have coming along in preclinical development, aiming for clinical readiness by the end of this year, our off-the-shelf vaccine program, EVX-04 targeted to AML, which will be a single vaccine approach for multiple AML patients. More to come on that. Infectious diseases, we remain focused on driving forward our preclinical assets, EVX-B1 against pathogen staph aureus, our B2 program against Neisseria gonorrhea and also in collaboration in -- with Afrigen on an RNA platform. EVX-B3, our options partner program continues to move forward with MSD. And before our more recent newer program on Group A Streptococcus is making great strides in initial early discovery component design. And our first viral program is continuing to make progress in terms of confirming the candidate components. So a lot going on in the organization. In Slide 9, I just wanted to remind the audience of our 2026 milestones and the fact that we have achieved the first one of those in our EVX-01 additional biomarker and immunogenicity data, and we remain on track in terms of updating on the approach of AI-Immunology in autoimmune disease, our 3-year data for the EVX-01 melanoma program, our planned strategy with the EVX-04 AML program and the early work maturing in our preclinical EVX-B4 program against Group A Streptococcus. And fundamentally, we are driving the partnership strategy to focus on the platform and the assets so that we can continue to build value in the company and focus on delivering those into early development where we believe we can add value. So at this point, I'd like to hand over to Birgitte, who will talk you through our R&D and AI-Immunology update. Birgitte Rono: Thank you, Helen. So today, I'll be focusing on our lead candidate, EVX-01. And as mentioned, this is our personalized neoantigen cancer vaccine currently in Phase II in advanced melanoma. And then I will present the exciting new data demonstrating the scalability of our AI-Immunology platform into the hard-to-treat deadly brain cancer glioblastoma. And lastly, I will showcase how we have applied AI-Immunology to design optimized vaccine antigens for an improved polio vaccine. So if you take the next slide. So as Helen mentioned, we presented EVX-01 Phase II biomarker and T-cell immune data at the AACR Annual Meeting here in April. And we reported that 86% of the EVX-01 vaccine target triggered a specific immune response, and this is substantially higher than what has been reported for other similar vaccine candidates. Furthermore, we also reported that 86% of the immunogenic vaccine target induced a de novo T-cell response, meaning that the EVX-01 vaccine specifically triggers novel T-cell responses and not just amplifying existing responses. And this is of great importance as induction of these novel responses have been linked to clinical benefit. Furthermore, we demonstrated a positive correlation between the predicted quality of the EVX-01 vaccine targets and the magnitude of the T-cell response induced by the vaccine targets. And this high vaccine target success rate, together with this positive correlation demonstrates the strong predictive power of our AI-Immunology platform. If you take the next slide. So EVX-01 continues to deliver strong data, adding to the already existing and promising clinical and immunological data package. So at ESMO last year, we reported a 75% overall response rate, including 25 complete responders and 92 sustained responses, indicating a durable benefit. So importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. And with the newly presented Phase II immune data, this further strengthens the picture with the 86% immunogenicity and the 86% de novo immune responses, demonstrating broad and consistent immune activation. So looking ahead, we have a clear development trajectory. We will announce 3-year data, including clinical outcome in the second half of this year. Further, we are evaluating and discussing additional relevant cancer indications and with further trials expected to be conducted in partnerships. And importantly, EVX-01 has already received FDA Fast Track designation, validating both the unmet need and then also the development potential. So overall, this positions EVX-01 very strongly as we move forward into the next phases of value creation. If you take the next slide. So let's turn our focus to the other promising data set presented at AACR. So in collaboration with Duke University, we demonstrated that our AI-Immunology platform scales beyond melanoma. And here, it's exemplified with glioblastoma or GBM. So GBM is the most common and the most aggressive primary malignant brain tumor. And despite surgery followed by chemoradiation, outcome remains very poor for these patients with a median overall survival of approximately 15 months and a 5-year survival below 10%. So using our AI-Immunology platform, we have evaluated tumor omics data from 24 GBM patients and demonstrated that a fully personalized vaccine design was feasible for all these cases. And importantly, these designs were based on 2 classes of antigens or classical neoantigens and also antigens derived from the dark genome so-called endogenous retroviruses or ERs. So in 21 out of the 24 designs, they included both types of antigens, 2 vaccine designs included only neoantigens and 1 design relied solely on the ER antigens. This analysis showcases the flexibility and the scalability of the platform to integrate antigen from different sources, fitting the patient tumor biology. So overall, the data demonstrate that AI-Immunology can address hard-to-treat low mutational burden tumors like GBM and it also supports broader applicability of the platform across different cancers. If you move on to the next slide. So another example of how AI-Immunology can be used to design improved vaccine was showcased at the World Vaccine Congress. And together with The Gates Foundation, we presented a new polio vaccine concept using AI-Immunology, we designed a novel hybrid capsid antigen and a novel de novo B-cell antigen with the aim of eliciting a strong and broad tumor response against all serotypes. And overall, this highlights the potential of AI-Immunology to reinvent classical vaccines with improved simplicity and also improved breadth. Take the next slide. So having highlighted progress across the key R&D program, let's step back for a moment and focus on AI-Immunology and the data validating its ability to generate high-quality product candidates. So AI-Immunology is clinically validated with positive outcomes in 3 out of 3 oncology trials. And preclinically, we have demonstrated proof of concept across multiple disease areas, including cancer with our IRF targeting off-the-shelf vaccine concept as well as in infectious diseases with several vaccine candidates targeting multiple bacterial and viral pathogens. And importantly, the EVX-01 concept is highly scalable with potential in other solid tumors beyond melanoma. Additionally, the platform's applicability in challenging cancer indications was further validated in GBM. So finally, AI-Immunology supports multiple modalities, including peptides, proteins and DNA and RNA, enabling both pipeline and also partnership potential. So in conclusion, we have demonstrated strong progress across our platform and our R&D pipeline, and we are looking forward to keeping you updated as we advance our programs further. So with that, I will now hand over to Thomas, who will present our quarterly financial results. Thomas Schmidt: Yes. Thank you, Birgitte. And as mentioned, I will now then present and take you through our Q1 '26 results. The highlights of the first quarter of the year really is a continued discipline that we have applied in our resource allocation, of course, aligned with our strategy and certainly investing into our value drivers. So really according to plan. And that also means that we are on track to deliver what we expect of an operational cash burn of roughly USD 14 million for 2026. That also underlines and reconfirms that our cash runway is into the second half of 2027 and remains as such. Also, as earlier communicated, not assuming any partnerships or deals that we will hopefully be making and communicating within that time frame. Looking at the P&L, we have operating expenses overall more or less in line with last year, but slightly reduced. It comes from our R&D with a minor increase as we continue, as mentioned before, to progress and advance our pipeline and programs according to plan. On the other side, our G&A expenses are slightly lower versus last year, also mainly driven by the fact that we have lower capital market costs in Q1 '26 versus the same period in '25. The first quarter resulted in a net loss of USD 3.6 million, again, according to our plan. On the balance sheet side of things on the next slide, reconfirming once again, our cash position and equivalent end of the quarter stands at $18.4 million, which confirms runway until the second half of '27. And the total equity has been reduced since year-end, really as a result of the net result of the first quarter, meaning that we have USD 13.2 million as equity at the end of the quarter. So all in all, financials according to plan, allocation into our main priorities and cash runway confirmed until the second half of 2027. With that, I hand it back to Helen for some concluding remarks. Helen Tayton-Martin: Thanks, Thomas, and thanks, Birgitte. And so I would just like to emphasize that we believe we've made a great start to 2026, achieving the first of our milestones with a really encouraging translational data from EVX-01. We've got various presentations that have been made that validate the capabilities and scalability of the platform, as Birgitte has explained. Business development remains a key priority in terms of engaging with organizations on the value of the assets that we have and the capability to develop those assets as we've talked a bit about. And the cash runway is maintained through to the second half of 2027. So we are rigorously following execution of our strategy and engagement externally and making great progress. So with that, I would like to hand back over to take some questions by the operator. Operator: Our first question comes from the line of Thomas Flaten from Lake Street Capital Markets. Thomas Flaten: Two for me. With respect to the 3-year EVX-01 data, ASCO is obviously too soon. But should we anticipate something like an ESMO readout? Or will you do it independent of a broader scientific meeting? Helen Tayton-Martin: So we will be updating in the context of a scientific meeting. We will not be sort of outside of that, that's not our intention. And we'll confirm which of the 4 conferences it will be once we're able to -- once abstracts are released. Thomas Flaten: I think the GBM data that you put out, albeit early, was very exciting, and obviously, a disease state and great need. Is it your strategic intent to take that into humans? Or would you seek a partnership based on the data you have now and perhaps some additional preclinical data? Helen Tayton-Martin: So we are very excited about the data. We agree it's really interesting and it's really exciting in a very difficult-to-treat disease. We would anticipate that will be something that we will be partnering. It sort of strengthens the overall personalized approach that we have developed with EVX-01, but probably more to come on that as more data and discussions mature, but it would be a partnering approach for that one, too. Operator: Our next question comes from the line of Michael Okunewitch from Maxim Group. Michael Okunewitch: Congrats on all the great progress. I guess to kick things off, I'd like to ask just a little bit about expansion and I guess, your design philosophy and strategy around that. So first off, when thinking about targets for expanded indications in cancer, in particular, is the plan to go after other diseases where PD-1s have historically been ineffective due to that synergistic activity of directing the antitumor immune response? Helen Tayton-Martin: So I think we've taken a lot of parameters into account. But Birgitte, do you want to comment on how we have been marshaling the approach internally to focus on the rare diseases? Birgitte Rono: Yes. So as mentioned, we are looking at multiple different antigen sources currently, and there's further development in this area in the company. So we would like to be able to provide a cancer vaccine for all patients independently of their antigen profiles or landscapes. So we have so far looked at more than 30 different indications, mapping out their seasonal burden, their ERV burden, et cetera, and can see that for many of these indications, we're able to -- with the capabilities we have currently to design a high-quality vaccine. And of course, one would need to further dive into medical need and current treatment landscapes to find the optimal subpopulations where our therapies would fit, but not necessarily in PD-1 low patient, it could also be in high. So it's mostly -- we are mostly focusing on understanding the antigenic landscape and fitting our therapies towards these profiles. Michael Okunewitch: When thinking about designing new vaccines, do you find that it makes more sense to use one personal vaccine and then see if you could expand that to multiple tumor types with the same vaccine for more universal coverage? Or does it make more sense to go tumor by tumor and create a new back of targets that are directed specifically at the common target for that given tumor type like melanoma or like glioblastoma and have an individual vaccine candidate for each of those different cancers? Birgitte Rono: So the way that we are approaching this is to look into a lot of data from certain indication and understanding, as mentioned, the landscape. If we do see that there are these conserved antigens, so antigens that are shared across patients, we would definitely develop an off-the-shelf vaccine just due to the fact that the statistics are more simple and also the cost for the manufacturing would be way lower than for a personalized approach. Further on, you can -- if there's an off-the-shelf therapy, you can immediately treat the patients and not have to wait for that personalized batch to be ready. So that's -- everything comes back to the patient omics data and the profiles that we are seeing in our analysis. For some indications, we know that developing an off-the-shelf cancer vaccine would be very challenging. So it clearly depends on these different biological profiles. Helen Tayton-Martin: I think the EVX-04 illustrates just where in that setting, I think, the high level of conserved has enabled us to produce a single vaccine for those patients. Michael Okunewitch: I appreciate the additional color and looking forward to the 3-year data coming up later this year. Operator: We will now take our next question. And this question comes from the line of Danya Ben-Hail from Jones. Danya Ben-Hail: Congratulations on the update. You mentioned that there are several parallel partnerships and discussions. Can you provide more detail on whether these discussions lean toward broad platform licensing or specific asset-based collaboration in future? Helen Tayton-Martin: So we obviously can't say much at this point. I think we have stated the priority around partnership on EVX-01. But as you've heard, that has broader applicability than melanoma in our minds. And that has obviously also gathered interest externally with partnering conversations also. Across our infectious diseases portfolio there are a number of assets there, which are of interest to a number of companies. So we can't really provide any more details than that. Suffice to say that we are trying to be strategic around the way we have the partnering discussions in terms of maximizing the value, whether it's from an asset group in infectious diseases or the approach with something like the personalized EVX-01, EVX-03 cancer vaccines. So obviously, we will -- as soon as we can tell you more, we'll be delighted to do so, but we're pushing forward on a more strategic basis, if you will, around how to get the most value out of the assets that we can produce from AI-Immunology. Danya Ben-Hail: Just one more question on the autoimmune platform part. So we should expect more details in the second half? Helen Tayton-Martin: Yes, that's our current plan and aligns to -- as is always generally with Evaxion, generally aligns to scientific relevant conferences to report on data. Operator: There are no further questions for today. I will now hand the call back to Helen Tayton-Martin for closing remarks. Helen Tayton-Martin: Thank you. Thank you very much. And thank you to all those who listened into the call, and thank you very much for the questions that we received. I think in summarizing, we are very enthusiastic and excited about the performance so far in Q1 2026. We are really just getting started and we are achieving our milestones as we have stated them to be. So very excited about the initial data, very excited about the additional updates to come later this year. With that, I'd like to thank you very much, and I think we'll be closing the call. Operator: Thank you. This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Evaxion A/s, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Evaxion A/s wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Evaxion (EVAX) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Investor releaseQuarter not tagged2026-05-07

Evaxion announces business update and first quarter 2026 financial results

GlobeNewswire
COPENHAGEN, Denmark, May 7, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces first quarter 2026 financial results. Business highlights (since last quarterly update) Evaxion has had a good start to the year executing on our plans and achieving our first milestone for 2026 as expected. Highlights include: New data demonstrating an 86% vaccine target recognition by AI-Immunology™ in personalized cancer vaccine EVX-01 is a further scientific validation of the platform’s precision in driving immune response. This marked our first milestone for the year Another new set of data confirming the platform’s unique scalability in glioblastoma Successful completion of the one-year extension of our phase 2 trial with EVX-01 paving the way for presentation of three-year clinical data in the second half of 2026 Presentation of potentially superior design concepts for new polio vaccines stemming from our collaboration with The Gates Foundation Organizational optimization for strategy execution with the promotion of Birgitte Rønø to the dual role of Chief Scientific and Chief Operating Officer and the election of Jens Bitsch-Nørhave to the Board of Directors Cash runway unchanged with cash at hand to fund operations into the second half of 2027 “We maintain strong operational momentum as we continue our work to consolidate our position as a leader in AI-based target discovery, drug design and development. The validation of AI-Immunology™ continues to be reinforced with a host of new promising data presented, which forms a solid foundation for our ongoing business development efforts. We are pleased to have further strengthened our organization to focus on these with the promotion of Birgitte Rønø and inclusion of Jens Bitsch-Nørhave as a formal member of our Board of Directors,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 m…Read full document

COPENHAGEN, Denmark, May 7, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces first quarter 2026 financial results. Business highlights (since last quarterly update) Evaxion has had a good start to the year executing on our plans and achieving our first milestone for 2026 as expected. Highlights include: New data demonstrating an 86% vaccine target recognition by AI-Immunology™ in personalized cancer vaccine EVX-01 is a further scientific validation of the platform’s precision in driving immune response. This marked our first milestone for the year Another new set of data confirming the platform’s unique scalability in glioblastoma Successful completion of the one-year extension of our phase 2 trial with EVX-01 paving the way for presentation of three-year clinical data in the second half of 2026 Presentation of potentially superior design concepts for new polio vaccines stemming from our collaboration with The Gates Foundation Organizational optimization for strategy execution with the promotion of Birgitte Rønø to the dual role of Chief Scientific and Chief Operating Officer and the election of Jens Bitsch-Nørhave to the Board of Directors Cash runway unchanged with cash at hand to fund operations into the second half of 2027 “We maintain strong operational momentum as we continue our work to consolidate our position as a leader in AI-based target discovery, drug design and development. The validation of AI-Immunology™ continues to be reinforced with a host of new promising data presented, which forms a solid foundation for our ongoing business development efforts. We are pleased to have further strengthened our organization to focus on these with the promotion of Birgitte Rønø and inclusion of Jens Bitsch-Nørhave as a formal member of our Board of Directors,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Research & Development (R&D) update Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. EVX-01 is our most advanced asset. Developed with AI-Immunology™, it is a personalized cancer vaccine designed to target multiple neoantigens; cancer unique proteins arising from mutations. We completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) last year with unprecedented results and presented new immunogenicity data from the trial at the American Association for Cancer Research (AACR) Annual Meeting last month. The data demonstrates that AI-Immunology™ identifies and selects the most therapeutically relevant vaccine targets as 86% of the targets included in EVX-01 trigger a tumor-specific immune response. This is a success rate much higher than what has been reported for other methods. The record-high vaccine target precision underscores the therapeutic potential of EVX-01 and is also a further validation of AI-Immunology™ as an effective tool for developing potentially transformational treatments in melanoma as well as potentially other cancer indications with high mutational burden. This is of course important for the technology itself, but also very supportive of our ongoing work to enter additional strategic partnerships and business development deals. At AACR, we also presented new data confirming the scalability of AI-Immunology™ allowing for its application in several diseases. This includes the deadly brain cancer glioblastoma, for which the platform uniquely can identify a novel source of targets to include in therapeutic vaccines, potentially enhancing their efficacy. The data was generated in collaboration with Duke University School of Medicine and has created significant interest in the field of glioblastoma, an area of high unmet medical need. We have completed the one-year extension of the phase 2 trial with EVX-01 with the last patient having last physician visit in April. In the third year, patients received EVX-01 as monotherapy, allowing an evaluation of the vaccine’s effect also as stand-alone treatment. Further, the three-year data may provide additional insights into potential enhanced treatment effects and durability of the induced immune response. We expect to present this data in the second half of 2026. We also maintain a high activity level within our infectious disease programs as showcased by our presentation of new polio vaccine design concepts stemming from our collaboration with The Gates Foundation. These could potentially be superior to currently used vaccines and provide a basis for designing a specific new polio vaccine. Current polio vaccines are based on inactivated or attenuated versions of the virus. Whilst these vaccines are effective, they each have shortcomings in certain settings. Thus, it has been a long-standing - but so far unreachable - goal to create a novel polio vaccine that combines the strongest aspects of the existing vaccines. To achieve this, we have deployed AI-Immunology™ to develop novel vaccine design concepts for a next-generation polio vaccine, which may enhance the chances of completing and sustaining polio eradication once and for all. Business development update We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships. To this end, we were pleased to promote Birgitte Rønø to joint role of Chief Scientific and Chief Operating Officer reflecting optimal internal organization to support partnering activities and internal strategy execution. Further, we are excited to have welcomed Jens Bitsch-Nørhave to our Board of Directors. With more than 25 years of leadership experience in the biotech and pharmaceutical industry, specializing in corporate strategy, global expansion, and dealmaking, Jens will be a strong contributor to our business development activities. First quarter 2026 financial results The financial results for the first quarter 2026 showed a net loss of $3.6 million, compared to $1.6 million first quarter 2025. This is explained by financial income from remeasurement of derivative liability in the first quarter last year, whereas the operating expenses and results were slightly reduced in first quarter 2026. Research and development (R&D) expenses were $2.3 million for the first quarter 2026, which is a slight increase compared to same period last year, as we progress our pipeline according to plan. General and administrative (G&A) expenses were $1.5 million for the quarter, compared to $1.7 million in first quarter 2025. The decrease is primarily driven by lower capital market costs. Financial income of $0.3 million first three months of 2026 compared to $2.4 million same period last year, is due to financial income recorded in 2025 from remeasurement of derivative liability from the January 2025 public offering. Cash and cash equivalents as of March 31, 2026, were $18.4 million, compared to $23.2 million as of December 31, 2025, and confirms our current cash runway until second half of 2027. Total equity amounts to $13.2 million as of March 31, 2026, reflecting the net result of the first quarter 2026 when compared to $17.0 million as of December 31, 2025. Evaxion A/S Consolidated statement of financial position data (USD in thousands) Evaxion A/S Consolidated statement of comprehensive loss data (USD in thousands, except per share data) Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

TranscriptFY2026 Q12026-05-07

FY2026 Q1 earnings call transcript

Earnings source - 52 paragraphs
Operator

Good day. Thank you for standing by. Welcome to the Evaxion Business Update and First Quarter 2026 Financial Results Webcast and Conference Call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one and one on your telephone. You will hear an automated message advising your hand is raised. To withdraw your question, please press star one and one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, CEO Helen Tayton-Martin. Please go ahead.

Helen Tayton-Martin

Thank you, and welcome everyone to Evaxion's Q1 2026 Business Update Call. I'm very pleased to be joined today by our CSO, Birgitte Rønø, our COO, recently promoted, we'll talk more about that, and Thomas Schmidt, our CFO, and our Head of Investor Relations and Communications, Mads Kronborg. We move to the first slide just to provide some orientation as to what we will cover today. We will spend a little bit of time on our achievements in the first quarter of this year and some notable changes that we have made in order to address and focus on our strategy. I will then hand over to Birgitte, who will talk through some of the recent highlights from our R&D portfolio on AI-Immunology platform.

Helen Tayton-Martin

Birgitte will hand over to Thomas, who will walk you through our Q1 financial results. Then we will have some concluding remarks before opening up the call for Q&A. If I move to the next slide, just to reiterate, we may make some forward-looking statements on the call today, and investors and all listening are guided towards our SEC filed documents. If I go past our introduction to slide 5. I just wanted to, as before, emphasize our four key focus areas within the organization and give you a sense of the momentum as we perform an update in each of those areas.

Helen Tayton-Martin

First of all, our core focus around business development and partnering, is very much underway and strengthened by the way we have reorganized the organization, somewhat, and I'll come on to that, to focus on the external outreach and positioning of the company, to a broader audience and also to raise the awareness of exactly what it is that Evaxion can deliver in terms of products and, the platform. I'm pleased to say that we have many discussions ongoing there, and we hope to report more on that later, as the year progresses. Secondly, in our R&D focus areas, we're delighted to talk about our recent data from our EVX-01 lead program phase II study in which we were able to update some of the translational data recently at AACR.

Helen Tayton-Martin

Birgitte will talk more, in more detail about the performance of the cells that we produce in relation to the vaccines given to the patients and the 86% immunogenicity conversion rate we have there. We also were able to present at AACR a new set of data preclinically in collaboration with our collaborators at Duke University on the scope to use the AI platform in Glioblastoma. We have always felt that the approach could be applied to other high mutational burden tumors, but also to others where high mutational burden was not a feature. That is very much part of how we were able to demonstrate the broader applicability of the platform in Glioblastoma. Again, Birgitte will speak more to that.

Helen Tayton-Martin

Finally, we were able to confirm the completion of the last patient, last visit in the extension phase of our EVX-01 program and our phase II trial. More to come on that later in the year. More broadly on the AI-Immunology platform, we continued to optimize and strengthen that around its ability to deliver products across our infectious diseases as well as oncology portfolio, and again, also in autoimmune disease, again, where we'll update later in the year. In this first quarter, I'm delighted to say that we were able to show some initial data on a new polio vaccine concept, presented in collaboration with the Gates Foundation.

Helen Tayton-Martin

Finally, as Thomas will come on to, we have maintained our disciplined allocation of resources aligned to our stated aims with the portfolio and the platform, and our cash runway remains unchanged into the second half of 2027. Moving to slide 6. As mentioned, we have reorganized slightly inside the organization. I'm delighted to announce the promotion of Birgitte Rønø to the combined role of CSO and COO, which really reflects on how we organize the company and how well it's been run in recent times, but also to enable me in particular to have a greater focus externally on behalf of the company in terms of our business development and our investor interactions. Separately and in parallel, we were able to welcome Jens Bitsch-Nørhave to our board of directors.

Helen Tayton-Martin

Jens Bitsch-Nørhave comes to us with a huge amount of experience in BD and corporate strategy and outreach in general, both from a biotech perspective, but more recently from J&J and Homrie, where he is currently Corporate VP and Global Head of Corporate Development. We're delighted with the way that we've been able to strengthen the organization to focus on our stated strategy to build and maintain what we have and build greater partnerships. On slide 7, just to summarize, we remain a lean and capable and focused team in terms of the management organization. Two of the members are here on the call with me today. Andreas continues to support and drive the organization's innovation strategy around AI-Immunology.

Helen Tayton-Martin

Our board remains the same, but with the addition of Jens, as I mentioned. Moving to slide 8 to set up our objectives and key milestones for this year. Just a reminder that Evaxion, over many years, now has the privilege of having a pipeline in phase II in oncology with our EVX-01 asset in advanced melanoma, our personalized neoantigen-directed peptide-based vaccine, where we've got great data, which Birgitte will touch on in terms of now and what to come. We have our EVX-03 program, which is a combination of personalized and ERV-based antigens on our DNA platform. Then we also have coming along in preclinical development, aiming for clinical readiness by the end of this year, our off-the-shelf vaccine program, EVX-04, targeted to AML, which will be a single vaccine approach for multiple AML patients. More to come on that.

Helen Tayton-Martin

Infectious diseases, we remain focused on driving forward our preclinical assets, EVX-B1, against pathogen Staphylococcus aureus, our EVX-B2 program, against Neisseria gonorrhoeae. Also in collaboration with Aphrogen on an RNA platform. EVX-B3, our optioned partnered program, continues to move forward with MSD. EVX-B4, our more recent newer program on Group A Streptococcus is making great strides in initial early discovery component design. Our first viral program is continuing to make progress in terms of confirming the candidate components. A lot going on in the organization. In slide 9, just wanted to remind the audience of our 2026 milestones and the fact that we have achieved the first one of those in our EVX-01 additional biomarker and immunogenicity data.

Helen Tayton-Martin

We remain on track in terms of updating on the approach of AI-Immunology in autoimmune disease, our 3-year data for the EVX-01 melanoma program, our planned strategy with the EVX-04 AML program, and early work maturing in our preclinical EVX-B4 program against Group A Streptococcus. Fundamentally, we are driving the partnership strategy to focus on the platform and the assets so that we can continue to build value in the company and focus on delivering those into early development where we believe we can add value. At this point, I'd like to hand over to Birgitte, who will talk you through our R&D and AI-Immunology update.

Birgitte Rønø

Thank you, Helen. Today I'll be focusing on our lead candidate, EVX-01. As mentioned, this is our personalized neoantigen cancer vaccine currently in phase II in advanced melanoma. Then I will present the exciting new data demonstrating the scalability of our AI-Immunology platform into the hard-to-treat deadly brain cancer glioblastoma. Lastly, I will showcase how we have applied AI-Immunology to design optimized vaccine antigens for an improved polio vaccine. If you take the next slide. As Helen mentioned, we presented EVX-01 phase II biomarker and T cell new data at the AACR annual meeting here in April. We reported that 86% of the EVX-01 vaccine target triggered a specific immune response. This is substantially higher than what has been reported for other similar vaccine candidates.

Birgitte Rønø

Furthermore, we also reported that 86% of the immunogenic vaccine target induced a de novo T cell response, meaning that the EVX-01 vaccine specifically triggers novel T cell responses and not just amplifying existing responses. This is of great importance, as induction of these novel responses have been linked to clinical benefit. Furthermore, we demonstrated a positive correlation between the predicted quality of the EVX-01 vaccine targets and the magnitude of the T cell response induced by the vaccine targets. This high vaccine target success rate, together with this positive correlation, demonstrates the strong predicted power of our AI-Immunology platform. If you take the next slide. EVX-01 continues to deliver strong data adding to the already existing and promising clinical and immunological data package.

Birgitte Rønø

At ESMO last year, we reported a 75% overall response rate, including 25 complete responders and 92 sustained responses, indicating a durable benefit. Importantly, more than half of the patients converted into an improved clinical response upon EVX-01 treatment. With the newly presented phase II immune data, this further strengthens the picture with the 86% immunogenicity and the 86 de novo immune responses, demonstrating broad and consistent immune activation. Looking ahead, we have a clear development trajectory. We will announce 3-year data, including clinical outcome, in the second half of this year. Further, we are evaluating and discussing additional relevant cancer indications and with further trials expected to be conducted in partnerships. Importantly, EVX-01 has already received FDA Fast Track designation, validating both the unmet need and then also the development potential.

Birgitte Rønø

Overall, this positions EVX-01 very strongly as we move forward into the next phases of value creation. If you take the next slide. Let's turn our focus to the other promising data set presented at AACR. In collaboration with Duke University, we demonstrated that our AI-Immunology platform scales beyond melanoma, and here it's exemplified with a glioblastoma or GBM. GBM is the most common and the most aggressive primary malignant brain tumor. Despite surgery followed by chemoradiation, outcome remains very poor for these patients, with a median overall survival of approximately 15 months and a 5-year survival below 10%. Using our AI-Immunology platform, we have evaluated tumor omics data from 24 GBM patients and demonstrated that a fully personalized vaccine design was feasible for all these cases.

Birgitte Rønø

Importantly, these designs were based on 2 classes of antigens, classical neoantigens and also antigens derived from the dark genome, so-called Endogenous retroviruses or ERVs. In 21 out of the 24 designs, they included both types of antigens. 2 vaccine designs included only neoantigens, and 1 design relied solely on the ERV antigens. This analysis showcases the flexibility and the scalability of the platform to integrate antigen from different sources, fitting the patient tumor biology. Overall, the data demonstrate that AI-Immunology can address hard to treat low mutational burden tumors like GBM, and it also supports broader applicability of the platform across different cancers. If you move on to the next slide. Another example of how AI-Immunology can be used to design improved vaccine was showcased at the World Vaccine Congress.

Birgitte Rønø

Together with the Gates Foundation, we presented new polio vaccine, a new polio vaccine concept using AI-Immunology. We designed a novel hybrid capsid antigen and a novel de novo T cell antigen with the aim of eliciting a strong and broad humoral response against all serotypes. Overall, this highlights the potential of AI-Immunology to reinvent classical vaccines with improved simplicity and also improved breadth. Take the next slide. Having highlighted progress across the key R&D program, let's step back for a moment and focus on AI-Immunology and the data validating its ability to generate high quality product candidates. AI-Immunology is clinically validated with positive outcomes in three out of three oncology trials.

Birgitte Rønø

Preclinically, we have demonstrated proof of concept across multiple disease areas, including cancer with our ERV targeting off-the-shelf vaccine concept, as well as in infectious diseases with several vaccine candidates targeting multiple bacterial and viral pathogens. Importantly, the EVX-01 concept is highly scalable with potential in other solid tumors, so beyond melanoma. Additionally, the platform's applicability in challenging cancer indications was further validated in GBM. Finally, AI-Immunology supports multiple modalities, including peptides, proteins, and DNA and RNA, enabling both pipeline and also partnership potential. In conclusion, we have demonstrated strong progress across our platform and our R&D pipeline, and we are looking forward to keeping you updated as we advance our programs further. With that, I will now hand over to Thomas, who will present our quarterly financial results.

Thomas Schmidt

Yes. Thank you, Birgitte. As mentioned, I will now present and take you through our Q1 26 results. The highlights of the first quarter of the year really is a continued discipline that we have applied in our resource allocation. Of course, aligned with our strategy and certainly investing into our value drivers. Really according to plan, that also means that we are on track to deliver what we expect of an operational cash burn of roughly $14 million for 2026. That also underlines and reconfirms that our cash runway is into the second half of 2027 and remains as such.

Thomas Schmidt

Also, as earlier communicated, not assuming any partnerships or deals that we will hopefully be making and communicating within that time frame. Looking at the P&L, we have operating expenses overall more or less in line with last year, but slightly reduced. It comes from our R&D with a minor increase, as we continue, as mentioned before, to progress and advance our pipeline and programs according to plan. On the other side, our G&A expenses are slightly lower versus last year. Also, mainly driven by the fact that we have had a lower capital market costs in Q1 2026 versus the same period in 2025. The first quarter resulted in a net loss of $3.6 million USD, again, according to our plan.

Thomas Schmidt

On the balance sheet side of things on the next slide, reconfirming once again, our cash position and equivalent end of the quarter stands at $18.4 million, which confirms runway until the second half of 2027. The total equity has been reduced since year-end, really as a result of the net result of the first quarter, meaning that we have $13.2 million as equity at the end of the quarter. All in all, financials according to plan, allocation into our main priorities, and cash runway confirmed until the second half of 2027. With that, I hand it back to Helen for some concluding remarks.

Helen Tayton-Martin

Thanks, Thomas, and thanks, Birgitte. I would just like to emphasize that we believe we've made a great start to 2026 achieving the first of our milestones with really encouraging translational data from EVX-01. We've got various presentations that have been made that validate the capabilities and scalability of the platform, as Birgitte has explained. Business development remains a key priority in terms of engaging with organizations on the value of the assets that we have and the capability to develop those assets, as we've talked a bit about. The cash runway is maintained through to the second half of 2027. We are rigorously following execution of our strategy and engagement externally and making great progress. With that, I would like to hand back over to take some questions via the operator.

Operator

Thank you. Our first question comes from the line of Thomas Flaten from Lake Street Capital Markets. Please go ahead.

Thomas Flaten

Hi, everyone. Thanks for taking the questions. Two for me. With respect to the 3-year EVX-01 data, ASCO is obviously too soon, but should we anticipate something like an ESMO readout, or will you do it independent of a broader scientific meeting?

Helen Tayton-Martin

We will be updating in the context of a scientific meeting. We will not be sort of outside of that. That's not our intention. We'll confirm which of the 4 conferences it will be once we're able to once abstracts are released.

Thomas Flaten

Got it. I think the GBM data that you put out, albeit early, was very exciting. Obviously, a disease state in great need. Is it your strategic intent to take that into humans, or would you seek a partnership based on the data you have now and perhaps some additional preclinical data?

Helen Tayton-Martin

We are very excited about the data. You know, we agree it's really interesting and it's really exciting in a very difficult to treat disease. We would anticipate that that will be something that we will be partnering. It sort of strengthens the overall personalized approach that we have developed with EVX-01. Probably more to come on that as more data and discussions mature. It would be a partnering approach for that one too.

Thomas Flaten

Got it. Appreciate it. Thank you.

Helen Tayton-Martin

Thanks. Question.

Operator

Thank you. Our next question comes from the line of Michael O'Connor from Maxim Group. Please go ahead.

Michael Okunewitch

Hey there. Good morning, everyone. Thank you for taking my questions today. Congrats on all the great progress.

Helen Tayton-Martin

Thank you.

Michael Okunewitch

I guess to kick things off, I'd like to ask just a little bit about Evaxion and I guess your design philosophy and strategy around that. So first off, when thinking about targets for expanded indications in cancer in particular, is the plan to go after other diseases where PD-1 have historically been ineffective due to that synergistic activity of directing the antitumor immune response?

Helen Tayton-Martin

I think we've taken a lot of parameters into account. Birgitte, do you want to comment on how we have been marshaling the approach internally to focus on the right diseases?

Birgitte Rønø

As mentioned, we are looking at multiple different antigen sources currently. There's a further development in this area in the company. We would like to be able to provide a cancer vaccine for all patients, indicant independently of their antigen profiles or landscapes. We have so far looked at more than 30 different indications mapping out their mutational burden, their ERV burden, et cetera, and can see that for many of these indications, we're able to, with the capabilities we have currently, to design a high quality vaccine. Of course, one would need to further dive into medical need and current treatment landscapes to find the optimal subpopulations where our therapies would fit. Not necessarily in a PD-1 low patient, it could also be in high. We are mostly focusing on understanding the antigenic landscape and fitting our therapies towards these profiles.

Michael Okunewitch

Mm-hmm. Then when thinking about, designing new vaccines, do you find that it makes more sense to use one personal vaccine and then see if you could expand that to multiple tumor types with the same vaccine for more universal coverage? Does it make more sense to go tumor by tumor and create a new batch of targets that are directed specifically at the common target for that given tumor type, like melanoma or like Glioblastoma, and have an individual vaccine candidate for each of those different cancers?

Helen Tayton-Martin

Oh, not again. Yeah.

Birgitte Rønø

The way that we are approaching this is to look into a lot of data from a certain indication and understanding, as mentioned, the landscape. If we do see that there are these conserved antigens that are shared across patients, we would definitely develop a off-the-shelf vaccine just due to the fact that the logistics are more simple and also the cost for the manufacturing would be way lower than for a personalized approach. Further on, you can, since it's an off-the-shelf therapy, you can immediately treat the patients and not have to wait for that personalized batch to be ready. That's everything comes back to the patient omics data and the profiles that we are seeing in our analysis. For some indication, we know that developing an off-the-shelf cancer vaccine would be very challenging. It clearly depends on these different biological profiles.

Helen Tayton-Martin

I think the EVX-04 illustrates just where in that setting, Birgitte, the high level of conserved has enabled us to produce a single vaccine for those patients. Yeah.

Michael Okunewitch

Thank you. I appreciate the additional color. I'm looking forward to the 3-year data coming up later this year.

Helen Tayton-Martin

Yep. Thank you.

Operator

Thank you. We will now take our next question. This question comes from the line of Tania Vanmale from Jones. Please go ahead.

Tania Vanmale

Hi. Congratulations on the update. Thank you for taking our questions. You mentioned that there are several parallel partnerships and discussions. Can you provide more detail on whether these discussions lean toward broad platform licensing or specific asset-based collaboration? Thank you.

Helen Tayton-Martin

We obviously can't say much at this point. I think we have stated the priority around partnership on EVX-01, but as you've heard, that has broader applicability than melanoma in our minds. That has obviously also gathered interest externally with partnering conversations also. Across our infectious diseases portfolio, there are, you know, a number of assets there which are of interest to a number of companies. I We can't really provide any more details than that.

Helen Tayton-Martin

Suffice to say that we are trying to be strategic around the way we have the partnering discussions in terms of maximizing the value, whether it's from an asset group in infectious diseases or the approach with something like a personalized EVX-01, EVX-03 cancer vaccines. We obviously will, as soon as we can tell you more, we will be delighted to do so. But we're well pushing forward on a more strategic basis, if you will, around how to get the most value out of the assets that we can produce from AI-Immunology.

Tania Vanmale

Thank you. Just a 1 more question on the Autoimmune platform part. We should expect more details in second half?

Helen Tayton-Martin

Yes. That's our current plan aligns to, as is always generally with Evaxion, generally aligned to scientific relevant conferences to report on data.

Tania Vanmale

Perfect. Thank you very much. Looking forward.

Helen Tayton-Martin

Thank you.

Operator

Thank you. As a reminder, to ask a question, you will need to press star one and one on your telephone. That is star one and one to ask a question. There are no further questions for today. I will now hand the call back to Helen Tayton-Martin for closing remarks.

Helen Tayton-Martin

Thank you. Thank you very much, and thank you to all those who listened in to the call. Thank you very much for the questions that we received. I think in summarizing, we are very enthusiastic and excited about the performance so far in Q1 2026. We are really just getting started and are achieving our milestones as we have stated them to be. Very excited about the initial data, very excited about the additional updates to come later this year. With that, I'd like to thank you very much, and I think we'll be closing the call.

Operator

Thank you. This concludes this conference call. Thank you for participating. You may now disconnect.

Investor releaseQuarter not tagged2026-05-04

Evaxion to announce business update and first quarter 2026 financial results on May 7, 2026

GlobeNewswire
COPENHAGEN, Denmark, May 4, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its first quarter 2026 financial results on Thursday May 7, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “s…Read full document

COPENHAGEN, Denmark, May 4, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its first quarter 2026 financial results on Thursday May 7, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

TranscriptFY2025 Q42026-03-06

FY2025 Q4 earnings call transcript

Earnings source - 34 paragraphs
Operator

Good day, and thank you for standing by. Welcome to the Evaxion Business Update and Full Year 2025 Financial Results Webcast and Conference Call. [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, and good morning, everyone. Thank you for joining us for Evaxion's business update following the reporting of our 2025 full year financial results yesterday. And apologies that this call is 24 hours later than we anticipated for technical reasons, we are delighted to be here today. My name is Helen Tayton-Martin, and I am honored to be leading this call for the first time as Evaxion's CEO. We move to the first slide. Okay. So on today's call, we will review the achievements of 2025 and touch on the milestones we anticipate for 2026. Our Chief Scientific Officer, Birgitte Rono, will then walk through our key R&D updates for the year, including the latest innovations from our AI immunology platform, after which our CFO, Tom Schmidt, will walk through our 2025 financial results before we close with a few concluding remarks and take questions. Right. Moving to the next slide. And of course, our comments and presentation today may contain forward-looking statements and all references on today's call, I'll refer to our filed SEC statements and specifically, our most recent 20th annual report for 2025 -- 2025 filed yesterday. So moving to the next slide. I will start with our 2025 achievements and our 2026 milestones. In 2025, we were very pleased to report tremendous progress across all pillars of the company. First of all, in business development, we were delighted with the progress in our collaboration with MSD and our infectious disease portfolio, with the decision by Merck to exercise its option over our EVX-B3 program candidate. Whilst the target for this program is not disclosed, we are very proud that this represents the first in-licensing to our knowledge of an infectious disease vaccine candidate identified and validated to an AI discovery platform. Whilst MSD chose not to exercise its option over our EVX-B2 candidate in gonorrhea, we remain very excited about the data and the prospects for this program, over which we have retained full rights and have seen significant interest. We were also pleased to enter into a collaboration with the Gates Foundation on the design of a new polio vaccine and are also seeing significant interest in our platform and pipeline programs more broadly from a number of parties. In R&D, we were very pleased to be able to present very positive [ to ] Phase II data at ESMO on our EVX-01 program with a personalized neoantigen-directed cancer vaccine in advanced melanoma patients. We also presented preclinical data at ASH on our first cancer vaccine we shared [ at antigen directed ] to a conserved endogenous retroviral EBR elements that we have identified in AML patients with our EVX-04 program. In our infectious disease portfolio, we were also able to move forward a new program with candidates identified from our AI immunology platform against [ Group A strep Coke ]. On the platform itself, the team has continued to innovate and use platform to not only identify optimal vaccine candidates, but improve their design biology for product delivery for us in our new automated module. And Birgitte will touch on all of these achievements shortly. We were also honored by the recognition of our AI immunology platform by the Galien Foundation for AI advances in human health. And finally, we were very pleased to see the capital influx of the business last year through financing, business development and the use of our ATM, which now gives us action a cash runway to the second half of 2027. And Thomas will talk more to this later. So moving to the next slide. Just as a reminder, our action has built a broad novel product basis pipeline of assets from its unique AI immunology platform. clinically validated with the cancer vaccine space with our EVX-01 [ peptide ] base vaccine in advanced melanoma that's supported by assets and data on DNA and RNA platforms and together with a preclinical pipeline of infectious disease vaccine candidate, focused on challenging targets remaining intractable with conventional approaches and subject to significant medical need. On to the next slide. This unique capability with AI immunology is something that we have also begun to investigate within the autoimmune field, given a wider range of diseases driven by autoimmune attack and the direct applicability of our platform to focus on immune mechanisms in disease. Autoimmune diseases affected over 14 million patients annually in the U.S. and are characterized by chronic debilitating conditions with treatment options focused primarily on the symptoms rather than the underlying cause of disease. Moving on to the next slide. This is why we believe our AI immunology platform is strongly positioned to focus on underlying disease mechanisms with greater specificity to identify autoimmune disease targets, which can be approached in different ways. There will be more to come on this later in the year. So finally, in the next slide, turning to our 2026 milestones. This year, we will be updating on our EVX-01 program with additional biomarkers and immunogenicity data, AACR and then the clinical data, 3-year data towards the [ later ] towards the end of the year. Well, we will be talking more about the autoimmune applications of our AI immunology platform and bringing forward data on our new EVX-B4 candidate in Group B [ rubric ] in the second half of the year. And finally, be ready to submit a regulatory application for our next EVX-04 candidate vaccine candidate for the shared her antigens in AML by the end of the year. And throughout, we remain committed to driving value from both our platform and our pipeline assets to partnership for our shareholders and patients. I'll now hand over to Birgitte to update you further on our R&D achievements.

Birgitte Rono

Thank you, Helen. So 2025 marked a turning point with significant advancement across our R&D pipeline and also and our AI platform. And additionally, as Helen alluded to, we also entered into the in-licensing agreement with MSD on the EVX-03 program. So our 2025 focus has been on strengthening our platforms predictive power, maturing key R&D assets and are building the foundation for future partnerships. So the 2025 achievements position us well as we move towards the data with milestones in 2026, that Helen just presented. So with that, I will begin by walking through individual key programs and platform development. So next slide, please. [ EVX-01 ], our personalized peptide-based cancer vaccine in advanced melanoma continues to deliver strong clinical data. So our 2-year Phase II data presented at an oral session at ESMO in October showed strong clinical outcomes, including a high objective response rate of 75% and complete response rate of 25%. Notably, 92% of the responders remained in response at this 2-year mark. Key biomarker data included the very high [ immunogenicities ] rate with 81% of all the individual new antigen administered across patients, giving rise to a specific T-cell response. So this very impressive heat rate outcompete data from similar programs conducted by others. And this truly underlines the precision of our AI immunology platform, to identify better than vaccine targets. Two key milestones are expected for this program, as Helen also alluded to, additional biomarker and [ genicity ] data expected in the first half of '26, and we also plan to communicate the 3-year data from a subset of patients that are currently in expansion part of the Phase II study, and that will be reported in the second half of '26. So importantly, we aim to conduct future trials in partnership ensuring the broadest possible impacts for patients. So moving to the next slide and EVX-04, our after-shelf therapeutic vaccine for acute myeloid leukemia or e-mail, we have generated a compelling preclinical base evidence supporting its development. In this program, we are focusing on a completely novel class of tumor antigens, so-called endogenous retroviruses or ERVs that are selectively and highly expressed in AML blast, making them attractive as therapeutic targets. So with AI immunology, we have identified millions of shortages from patient sequencing tumor data and designed the [ EVX-04 ] vaccines with 16 optimal ERV [ anti fragment ] selected based on craft patients [ pellets ] and also on the immunological potential. So key data include invite vaccination studies, demonstrating that all of these 16 fragments in the vaccine induced a strong specific immune response and further that EVX-04 prevents tumor growth in several of our tumor [ virus ] and induce strong T-cell responses. So again, these findings reinforces the power of our platform. And here, we have expanded it to uncover unique tumor antigens that are not accessible through traditional discovery methods. Next slide, please. As we progress towards clinical business for EVX-04, we have completed key steps, including antigen selection and lead development we have conducted preclinical efficacy studies and are currently conducted further human cell-based translational assays. CMC work and GMP manufacturing are advancing according to plan. And the next major milestone for this program is the submission of the clinical trial application in the second half of '26, which enabled first in human system. So this program is a prime example of how AI immunology accelerates vaccine design from concept to clinic. So next slide, please. Now turning to our key indexes disease programs. So after retaining the full global rights to EVX-B2 late last year, we are now fully in control of the development of this highly differentiated vaccine candidate targeting -- gonorrhea. So our preclinical data package is strong and comprehensive demonstrating significant protection in a mouse infectious model. We have demonstrated broad efficacy against 50 clinically relevant -- dates reflecting coverage across diverse strengths and further induction of significant [ una ] and cellular responses in mice, and we have also demonstrated a well-established mechanism of actions supported by potent antibody-dependent complement-mediated killing. So collectively, these results position EVX-B2 as one of the most advanced and differentiated infectious disease preclinical gonorrhea vaccine candidates in an area of high unmet need where no approved vaccine exists today. So given the strength of our data, we see a clear opportunity to engage with potential partners to progress the program towards clinical development. So next slide, please. So a number of our key infectious disease vaccine program is EVX-B1. In this program, we are developing a margin target vaccine against cytomegalovirus or CMV and instead of relying on a single glycoprotein or limited set of glycoproteins, the program integrates both these well-described glycoprotein and novel antigens to target the prior -- from multiple complementary angles. So this broad multicomponent strategy is designed to enhanced vaccine efficacy and also to reduce the risk of viral escape. So we have applied AI immunology for both antigen optimization of the known glycoproteins and for identification of 2 novel antigens. So first, we improved these established CMV antigens that are essential for virus neutralization. And as part of this, we have engineered the glycoprotein B antigen, by locking in a prefusion state. And this AI analogy designed a construct has demonstrated a superior neutralization capacity compared to the native program. And secondly, we are identifying and validating entirely novel antigens and several of these -- they have already demonstrated the ability to inhibit [ Vinten ] further, we are characterizing them at the moment. So supported by this strong preclinical data, EVX-B1 represents a highly promising program for continued development and for future partnership discussions. Next slide, please. So now turning to the recent development of our AI-Immunology platform. So our AI-Immunology platform continues to expand capability. So the platform integrates [ multiomic ] data sets to generate ranked antigen lifts within 24 hours. So in October last year, we launched a an automated vaccine design module enabling sequence and structural optimization directly from this short-listed engines. At this end-to-end automation significantly reduced cost development time and also this. So next slide, please. So more specifically, the automated module enhances design of [ Sage ] antigen constructs, enabling higher expression, better formulation and improved manufacturability. So this capability directs the design of [ salable ] antigen constructs and also stabilizing antigens using in various posing producing more reliable antigen construct vendor, wire side variance. There is a faster and more cost-effective design cycle fully integrated into our antigen discovery and vaccine optimization workflow. So this strengthened the foundation for all of our programs across oncology and infectious diseases. So in conclusion, we have seen strong progress across our platform and our R&D pipeline, and we are encouraged by the momentum and we look forward to keeping you updated as we advanced to 2026. And with that, I will now hand over to Thomas, who will go us through our financial business.

Thomas Schmidt

Yes. Thank you, Birgitte. And also a warm welcome from my side to our call today. And I will now walk you through the financial results for 2025. So turning to the next page. We have, throughout 2025, been really successful in expanding on our cash runway and also strengthening on our equity side. This has happened throughout the year through public offering and the use of ATM we did in January, followed by the MSD exercise fee and the ATM used in September. And furthermore, the exercise of investor warrants from our January offering in October and November, all summing up to a cash inflow of USD 32 million. Furthermore, as also shown on this slide, our EIB debt-to-equity conversion done in July of USD 4.1 [ billion ]. We've reduced certainly our cash -- future cash out and thereby certainly also expanding and extending our cash runway. And finally, with our filing in December of our prospectus supplement regarding our ATM. It has now created us with further flexibility ability and options as we move forward with expanding our pipeline and platform also. So really, really underlines the strong execution throughout the year. And turning to the next slide. that also leads into the highlights of 2025, where we really have delivered on all the targets that we set and we are progressing towards our aim of becoming a sustainable self-funding business. Both revenue and costs have improved while at the same time, we are continuing to invest in our platform and in our pipeline programs. As just mentioned on the previous slide, activities and execution of the MSD deal, the EIB debt conversion, our ATM and capital market activities have not only improved our cash position and runway, but has also significantly strengthened our equity. And with improved cash runway and equity -- equity we have created more stability and certainly have also reduced uncertainty. So I think that is really, really also a highlight for '25. And again, with the update of [ F3 ] and ATM, we have removed the constraints of baby shelf and also provides us far better flexibility and options in support of our long-term strategic initiatives and also the long-term plans we do have. Next slide. is on our profit and loss statement. As I just mentioned, revenue has improved, but also we've improved on our operational costs. So we've actually been successful in long in our operational spend whilst at the same time delivering on the quality that we would want to do from a pipeline and platform perspective. revenue certainly stems from our NST option exercises, but also important to mention, we also had a grant from the Gates Foundation that also has come in 2025 -- apologies. Net financial position of [ $4.6 million ] is driven by a premium that we received from -- our debt conversion -- debt-to-equity conversion from [ EIB ] and against that goes remeasurement of a derivative liability as some of our warrants or our [ launch ] from the public offering in January were in a different exchange setting, so the USD versus our reporting of DKK. Net loss for the year, [ $7.7 million ], certainly a better in compared to last year. And as I said before, also a good step on the way of becoming a sales funding and profitable business. Next slide, on the balance sheet. since we ended the year with a cash position of USD 23 million with a runway that now is extended into half year 2 of 2027 in certainly also a significant improvement compared to last year. And this, of course, will be used for operations expenses and investing into our platform and pipeline. We currently have an outstanding -- we have a total outstanding ADS of $8.3 million when assuming that all shares have been converted into ADSs. We've also, through the investor warrants exercise has been reducing the outstanding warrants in terms of ADSs by $1 million. which leaves another [ 2.8 million warrants ] outstanding. So also an improvement in that and really drives in the right direction. So in summary, from a financial position, we have during 2025, established a far better foundation that really makes us puts us in a good position to continue our execution of strategy and business for '26 and the years beyond. With that, I hand it back to Helen for some final concluding remarks.

Helen Tayton-Martin

Thanks, Thomas. And just moving to the last slide. In summary, 2025 was a year of strong operational momentum for Evaxion, in which we achieved several key milestones. Overall, we strengthened the business considerably to the validation of our strategy with our AI-Immunology platform, delivering on both data and partnerships. This, in turn, has enabled us to both strengthen our financial position and consolidate our position as a leader in AI-based of discovery, design and early development. With a number of potential partnership discussions ongoing, we are already funded into the second half of 2027 through the financial milestones achieved in 2025. So we're in a good position to move forward through 2026. With that, I'll hand over to the operator for questions.

Operator

[Operator Instructions]. Our first question today comes from the line of Thomas Flaten from Lake Street Capital Markets.

Thomas Flaten

Maybe to start broadly, Helen, you've been in the seat now for a few months. I'm just curious if you could provide some overarching commentary on what you have implemented or are going to implement -- any changes in strategy? And any bigger picture notes like that, that could help us with the context of your tenure?

Helen Tayton-Martin

Sure. Thanks. Thanks for the question. Yes, I joined at the end of November last year. So the last 3 months have flown by. But I already have a strong impression from my prior seat on the Evaxion Board. In terms of bigger picture, changes. I think the fundamental action remains really strong. And in fact, I think they have only got stronger through 2025. So the ability to have an AI platform that is built up over many years, many iterations, grounded in data and testing for that data in the lab, and ultimately in the clinic has really strengthened the core offering. So I remain really excited about the power of the platform in the oncology space and also in the infectious disease space. And I think we're sort of seeing a lot more traction around what we can do with the platform now from external engagement. So I think the fundamental strengths and core of what Evaxion has to offer is even stronger now than potentially before. And I think in a world of AI, everything, actually getting to products, actually producing candidates that can generate vaccines that generate a biological response and the clinical response is meaningful and is becoming recognized as meaningful, certainly in our partnering conversations, et cetera. So I think that, that is core. So clear observation I had before coming into the company and certainly strengthened by all my observations within it. and even more impressed by the team that's in place that can deliver on this. I think in terms of the overall strategy, what have Evaxion has done well is that early discovery, the early validation, that deep scientific and informatic embedded expertise, and we can certainly bring things forward into early clinical development, late preclinical, early clinical. And I think what we're going through at the moment is a process of really optimizing where we see the most value in the near term, both in terms of our oncology assets, but also within the infectious disease area. I think we are not positioned to take too much further forward into the clinic. So we've been very cautious about that but we certainly see strength in getting interest from external parties around the assets that we've already got. And actually, the capability of the platform. So there's not a fundamental change to strategy, but I think a sharpening and the deepening of focus around the assets that will have the most value. I hope that's helpful.

Thomas Flaten

Yes, that's great. And just keying off of your last comment there about taking products into the clinic. You mentioned with EVX-04 in Birgitte's presentation that you would be looking to submit regulatory paperwork. Is that a product that you think you have to take into Phase I given that herbs are a bit new, a bit different in order to attract a partner interest?

Helen Tayton-Martin

I think that's a very good question. We are certainly preparing to take it into the clinic, and we believe that we can do that to gain some initial proof of concept. There's a lot of interest around the platform at that particular metacandidate antigens in the vaccine. I think we're doing some further validation, which I think will continue to strengthen it. So the answer in short is not necessarily, but clearly, the more critical validating data that we can add to the package. The stronger the value proposition to an external partner, and that's obviously what we're all about is maintaining the -- building the value for as long as we can to strengthen our position. And I think we're very confident about what we can do with it preclinically and potentially clinically.

Operator

Our next question today comes from the line of Michael Okunewitch from Maxim Group.

Michael Okunewitch

Congrats on all the great progress you made. I guess to start off, I'd just like to see if you could comment a little bit on the partnering efforts for EVX-01. And in particular, if there's anything that you've heard either in your feedback from partners that you think you're still would be particularly important for us to watch for from the upcoming data releases, whether that's the 3-year data or the biomarker immunogenicity. Is there anything in particular you think is key for driving these partnering discussions?

Helen Tayton-Martin

So that's a really good question. And I mean, clearly, the cancer vaccine space has had something of a checker passed -- way back, but more renaissance, I think, in the checkpoint era. And I think our data is certainly resonating with companies who are interested in the cancer vaccine area, understand the nuances around getting, I think, strong cancer -- antigens, [ presliced ] cancer antigens for not just immune recognition but for clinical benefit. So the -- it is a complex therapy to administer, but it is also potentially an effective therapy. And I think the sorts of things that gain interest of the -- not just the response rate that we've seen in 2 years, 1 year than 2 years at ESMO, but also the recognition of the antigens, the numbers that the [indiscernible], and I'll ask you to add comment to this as well. So I think the -- we're in a strong position with that updated clinical data package that we have, the translational data, I think it's going to be interesting. It continues to -- so why and how the immune response is happening in parallel to the clinical response. So that is, I think, a differentiator and also in the population, the advanced population rather than adjuvant melanoma population. And clearly, I think we're also seeing interest in this whole approach in other high mutational burden cancers too. So beyond melanoma knows of it. I think those are the differentiators thinking about where else this is applicable accolading the different biological parameters, the translational insights that we're seeing that's somewhat different to how others have reported on this with similar approaches. So quite a bit of interest. I think the number -- to be honest, a number of companies are on the fence, but we're looking with interest and very interested in the shared approach -- the share approach that our EVX-04 program offered. Birgitte, do you want to add some further comments?

Birgitte Rono

So there's no doubt that the ability of our AI immunology platform to identify the relevant targets and is getting a lot of interest from potential partners and also from the academic community. And with this 81% hit rate, as we call it, I think this is very impressive. We have, of course, looked at other similar programs and seen that most of them are reporting hit rates way below 60%, meaning that the antigens that they are including in their vaccines are not all able to induce a specific T cell response. And this is, of course, a testament to the position of our platform. So that's one of the key elements. And another point that I would like to make is that we do see EVX-01 as not just a therapy for advanced melanoma. We believe that the same concept can be very useful in other occasions where there are a high mutational burden, meaning that there are several antigens to choose from. That includes many of the high prevalent cancer indications. It could be non-small cell lung cancer and also some of the colorectal cancers.

Michael Okunewitch

Thank you. I appreciate that additional color on that. And then as a follow-up, I wanted to ask if you could provide a bit more color on how you're applying the AI immunology platform to autoimmune disease. You identified this as a new area of interest. And do you expect that this would be more focused on allergies? Or would you focus more on the major large autoimmune and inflammatory diseases. Any additional color you could provide on that would be helpful?

Helen Tayton-Martin

Sure. I think the first thing to say is it's early in terms of our prioritization of the indications, but we've certainly done some work around that based on parameters, which I'll -- Birgitte you're happy to comment on that, I think, high level in terms of what's guiding where we focus will be -- that would be good.

Birgitte Rono

Yes. So we have done a lot of analysis on most prevalent autoimmune diseases, and we do see a clear fit for our platform. I mean, we, of course, need to further improve it and build a few additional smaller unit that allows us to apply the immunology. But we do have many things in place that can be directly applied in this area. So we will, of course, share more when we have done both analysis on which key indications we will pursue and also when we have done a little bit more work on adjusting AI-immunology, so it fits these diseases. But we should remember to say that there's a lot of these smaller units we call them building blocks that we can directly apply for these tax of diseases. So not only for autoimmune diseases but also for other diseases where there is a strong immunological component. So of course, we need to build a little bit, but the majority is already in AI-Immunology.

Operator

Our next question today will come from the line of RK from H.C. Wainwright.

Swayampakula Ramakanth

Thank you. This is RK from H.C. Wainwright. Just to start off, Helen, a quick question for you. You have basically, we've been an architect and multibillion dollar balances at that [ immune ] especially the large deal that was transacted with GSK. And also, you have heard a lot of experience in transactions. And while Evaxion is technically a very strong company, they have always had a difficulty in translating that language into meaningful transactions. Of course, Merck is a pretty strong partner. Based on your experiences, and how you manage to translate that. What sort of discussions could you have at this point? especially when talking with large-cap pharma, I'm convinced them that an AI tools predictability is as good as a physical assay and get them to start looking into some of the products that Evaxion is generating.

Helen Tayton-Martin

Thanks for the question. I think there are probably multiple dimensions to answer that question to the extent that it is possible to answer it at this point. One is that A lot of this is to do with timing. It's to do with data that validates that it's more than a sort of an AI platform. And I think actually, the fact that we have the scope to validate and iterate candidates target discovery with candidate development with cancer validation is something really novel that we're generally out there. And when I said timing -- there are obviously many of the large pharma, most of them will all have in-house AI platforms running in one form or another. But I don't think there are many that have got this sort of integrated long sort of longitudinal depth of expertise that actually has. So really, is that this is about crystallizing the offering through the validation of the cannabis we have and sort of being in dialogue with the right people. And you mentioned my background was a long time, 17 years in my precise company, building relationships establishing contact, understanding and listening to strategy, looking at the wider picture. These are all things that are very much part of how deals get done. And ultimately, it's down to relationships and credibility and really having something that fits the need. And all I can say at this point is we're reworking up some of those approaches and some of those themes in terms of how we are approaching potential partnering interaction, I have to say that the action team is well known with quite a few of these groups, but we're building and expanding that profile. And I think that's critical to the future success in partnering conversations. So it's being what you say you are in front of the right...

Swayampakula Ramakanth

Perfect. Then going into relationships with Merck, especially regarding EVX-B2, Merck decided to extend the evaluation of the molecule rather than exercise the option at this point. Is this a function of them trying to do additional experiments or functional assets? Or are they requesting from new additional work so that they can come to a conclusion?

Helen Tayton-Martin

Sorry, are you referring to the extension that they had last year before the opt decision there?

Swayampakula Ramakanth

Yes, yes.

Helen Tayton-Martin

I mean we can't really comment on, obviously, the combination nature of the interactions. All I can say is that sometimes is sort of R&D programs when they are back and forth and shared between organizations don't always run to plan. And so sometimes that requires looking at things again. But ultimately, then there are time frames around things, which have to follow through. So I think there are reasons for not taking sort of obviously, their reasons not multidimensional. All I can say is that we remain really excited about the data. We actually continue to build data on the program internally throughout that period of time as well. So we feel very, very bullish and strong about the data package but how and why I wanted to do that work? Or is it something we probably we can't really add any more commentary on.

Swayampakula Ramakanth

Okay. On the EVX-01 durability, Birgitte, so you have shown 92% of the responders showing sustainability, be it 24 months. As we are looking forward to the 3-year durability what sort of exhaustion markers are you going to be tracking so that we understand how well the durability is.

Birgitte Rono

Yes. Thank you for that question,. So it's correct that 92% of the responders remained in response with this 2 year mark. And I guess your question was related to the T-cell extortion -- as yes, we do a deep scar profiling, looking at activation marker, extortion markers and also at different phenotypes of the T-cells, so including CD4, CD8, but also looking into whether there are regulatory T-cells coming up. And so far, we have demonstrated that -- the profile of the T-cells are very favorable. So in more of the activation or effective type of sales and not too many that are having exhaustion markers. We also see that there's a like dominance of CD4 T-cells and with some patients are also mounting a CD8 T-cell by time. So we have -- during this extension phase of the study, we have been collecting additional blood samples that are currently being analyzed in our lab. So not to comment on that, but it's very exciting. And since EVX-01 is giving us a immunotherapy in this extension phase, we're also very curious of understanding what EVX-01 can drive on its own without having the background of the checkpoint inhibitors.

Swayampakula Ramakanth

Okay. One last question from me. This is on the EVX-04...

Operator

In the interest of time, we will move to our next question. And our next question comes from the line of Daniel Ben Hill from Jones.

Daniel Ben Hill

On the autoimmune disease program, can you provide more detail on your strategy for validating early candidates?

Helen Tayton-Martin

Thanks for the question. I mean it's early, and we probably cannot provide more details. But, Birgitte, do you want to comment on how we think about it.

Birgitte Rono

Yes. So the first step is to settle on an indication. So we have done landscaping. We've done dianalysis on looking at the top 10 most prevalent ultimate diseases, and we are now narrowing down which one could be the most, I would say, interesting from a -- from our perspective, where there is a nice fit for AI-Immunology. And so that work is ongoing. We've almost completed it. And next step is to focused on building the additional smaller units that we will be needing in AI immunology to enable us to develop therapies for these diseases. And in parallel, we are also sitting on mouse models in our lab, so ensuring that we can also test the candidates that AI-Immunology is designing. So that is the current plan. So pretty traditional way of analyzing our existing the candidates that AI immunology is designing.

Operator

Thank you. This concludes today's question-and-answer session. I will now hand the call back to Helen Tayton-Martin, CEO, for closing remarks.

Helen Tayton-Martin

Thank you very much for everyone participating on the call today. It's been a great year of 2025 of transforming the company for Evaxion delivering on multiple milestones, leaving us in a stronger financial position than for some time, where we hope we can take the company forward and deliver on our 2026 milestones and continue to strengthen the value that comes from the platform and the asset. So thank you for your questions and your engagement, and we look forward to our next update. Thank you. Bye-bye.

Operator

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

Investor releaseQuarter not tagged2026-03-05

Evaxion announces business update and full year 2025 financial results

GlobeNewswire
COPENHAGEN, Denmark, March 5, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces full year 2025 financial results. Business highlights 2025 was a transformational year for Evaxion with significant strengthening of our fundamental business both strategically, scientifically and financially through achievement of several milestones. Highlights include: The historic licensing of our infectious disease vaccine candidate EVX-B3 by MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) Unprecedented two-year phase 2 data for our personalized cancer vaccine candidate EVX-01 demonstrating impressive clinical outcomes Replenishing of our R&D pipeline adding EVX-04, an off-the-shelf vaccine candidate for acute myeloid leukemia (AML), and EVX-B4, a prophylactic vaccine candidate targeting Group A Streptococcus Collaborating with the Gates Foundation to design new polio vaccine Receiving the Galien Foundation Prix Bridges Award for Best medical technology/AI advances in human health for AI-Immunology™ Strengthening of our financial position and equity through partnership deal and capital market activities totaling more than $30 million, in addition to the debt conversion agreement with the European Investment Bank (EIB) Improving future funding options by amending our At-The-Market (ATM) equity program “We made tremendous progress in 2025 across all aspects of our business and achieved several vital points of validation of both our platform, R&D pipeline and strategy. This, coupled with the fact that we have cash on hand to fund our operations into the second half of 2027, puts us in a strong position to further progress both AI-Immunology™ and our R&D pipeline as per our strategy for long term value creation. We maintain our focus on building value through our platform and pipeline assets through partnerships and strong operational execution to deliver the milestones laid out for 2026,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET tomorrow, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register i…Read full document

COPENHAGEN, Denmark, March 5, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, provides business update and announces full year 2025 financial results. Business highlights 2025 was a transformational year for Evaxion with significant strengthening of our fundamental business both strategically, scientifically and financially through achievement of several milestones. Highlights include: The historic licensing of our infectious disease vaccine candidate EVX-B3 by MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA) Unprecedented two-year phase 2 data for our personalized cancer vaccine candidate EVX-01 demonstrating impressive clinical outcomes Replenishing of our R&D pipeline adding EVX-04, an off-the-shelf vaccine candidate for acute myeloid leukemia (AML), and EVX-B4, a prophylactic vaccine candidate targeting Group A Streptococcus Collaborating with the Gates Foundation to design new polio vaccine Receiving the Galien Foundation Prix Bridges Award for Best medical technology/AI advances in human health for AI-Immunology™ Strengthening of our financial position and equity through partnership deal and capital market activities totaling more than $30 million, in addition to the debt conversion agreement with the European Investment Bank (EIB) Improving future funding options by amending our At-The-Market (ATM) equity program “We made tremendous progress in 2025 across all aspects of our business and achieved several vital points of validation of both our platform, R&D pipeline and strategy. This, coupled with the fact that we have cash on hand to fund our operations into the second half of 2027, puts us in a strong position to further progress both AI-Immunology™ and our R&D pipeline as per our strategy for long term value creation. We maintain our focus on building value through our platform and pipeline assets through partnerships and strong operational execution to deliver the milestones laid out for 2026,” says Helen Tayton-Martin, CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET tomorrow, presenting the business update and financial results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. 2026 milestones Based on the strengthening of Evaxion during 2025 we continue the execution of our strategy of creating value from both our platform and R&D pipeline assets through partnerships. This is reflected in our milestones for 2026 covering both the continued expansion of AI-Immunology™ and the progression of our R&D pipeline programs as outlined below. Leveraging the unique scalability of AI-Immunology™, we will expand the platform to also enable the discovery and development of drug candidates targeting autoimmune diseases (AIDs). This will increase the pool of diseases for which we can potentially discover and develop new treatments. AIDs are characterized by high unmet medical need and offer significant partnership potential across all stages of drug development. Currently, we are optimizing the indication strategy for development of AI-Immunology™ in the autoimmune space for use in the second half of 2026. In oncology, we will continue to strengthen the data package for EVX-01, our personalized cancer vaccine in advanced melanoma, with additional biomarker and immunogenicity findings as well as three-year clinical results from the extension of the phase 2 trial. We plan to present both datasets at key medical conferences during the year. Progressing our cancer vaccine pipeline also includes the preparation for a phase 1 trial with EVX-04, our conserved antigen vaccine in AML. Regulatory filing is expected before the end of the year. In our infectious disease pipeline, the most significant expected event is the design and preclinical validation of antigens for our Group A Streptococcus vaccine, EVX-B4, with new data anticipated to be presented at a conference in the second half of the year. Further to our specific 2026 milestones, we maintain our efforts to derive value from partnerships. This includes platform deals focusing on target discovery, candidate, validation and optimization plus pipeline deals focusing on validated assets. We continue to see strong external interest in both areas and are engaged in numerous partnership discussions. We maintain strict cost control and are diligently prioritizing and optimizing our cash and resource allocation. For 2026, we expect a cash expenditure similar to 2025, e.g. an operational cash burn of ~$14 million. Research & Development (R&D) update Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. The personalized cancer vaccine EVX-01 is our most advanced asset. Developed with AI-Immunology™, it is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We successfully completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) with unprecedented results presented at an oral session at the prestigious ESMO 2025 conference. Clinical results included an objective response rate of 75%, as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. Additionally, a durable clinical benefit was observed with 92% of patients still responding at two years of follow-up with no relapses. In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent, specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other neoantigen prediction approaches. Further immune data, presented at the SITC 2025 conference, showed that in subsets of analyzed patients, clinical responses were accompanied by a rapid and sustained induction of EVX-01-specific T-cells. While all these data are encouraging and validates the clinical potential of EVX-01, it also provides a wider validation of AI-Immunology™, its predictive capabilities and its ability to find relevant vaccine targets associated with high clinical efficacy. This validation was further supported both by the licensing of an undisclosed infectious disease program (EVX-B3) by MSD, the collaboration on polio with the Gates Foundation and the Galien Foundation award and serves as an important foundation on the use of AI-Immunology™ for all of our partnering discussions. We received the Galien Foundation Prix Bridges Award for Best medical technology/AI advances in human health for AI-Immunology™, further reinforcing our positioning as a leader in the field of AI-based target discovery. EVX-04, the AML vaccine added to our pipeline in 2025, is developed through the ability of AI-Immunology™ to identify non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome. These antigens are selectively expressed in specific tumors but absent in normal tissue, making them highly attractive cancer vaccine targets. Using sequencing data from AML patients, the AI-Immunology™ platform first identified ERV tumor antigens and then mined these to determine smaller fragments with the potential for immune recognition. From the five million ERV antigen fragments discovered, AI-Immunology™ combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. In December 2025, we presented new data for EVX-04 at an oral session at the ASH 2025 meeting, another very prestigious conference. The data demonstrates that all 16 ERV fragments included in EVX-04 elicit a specific immune response and that the vaccine candidate prevents tumor growth in preclinical tumor models. Thus, the data confirms our belief that EVX-04 could significantly improve treatment options for AML patients. It is another example of the unique capabilities of AI-Immunology™ in finding novel targets enabling the design of therapies with transformative potential. These capabilities are also applied in our EVX-V1 program targeting Cytomegalovirus (CMV). AI-Immunology™ has discovered novel CMV antigens and EVX-V1 is a next-generation, multi-component vaccine program combining these novel AI-discovered antigens with AI-optimized versions of established CMV vaccine antigens. This broader multi-targeted strategy is expected to strengthen the protective potential of the future vaccine. Data announced in November 2025 demonstrates protective effects of lead antigens in the program. These previously unexplored CMV-antigens induce specific immune responses, inhibit viral infection and reduce cell-to-cell spread in cellular and animal viral infection models. These are significant discoveries since very few protective CMV-antigens have been identified despite decades of intensive research. Business development update We are immensely proud to be the first company ever to license an AI-discovered preclinical vaccine candidate to a pharmaceutical company through the agreement on EVX-B3 with MSD. We received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million. Subsequently, whilst MSD chose not to exercise its option on our Gonorrhea candidate EVX-B2, we retain full global rights to this exciting program and its strong data package. We are in the process of looking for another potential licensing partner. We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of strengthening our platform and building value through multiple partnerships. Strengthening of financial position and equity Our financial position and equity were significantly enhanced through an influx of new capital totaling more than $30 million in 2025, including the $7.5 million option exercise fee from MSD. As a result, we significantly extended our cash runway and now hold cash on hand to fund our operations into the second half of 2027. Our equity was further bolstered by the debt conversion agreement with the EIB, which also has a rolling positive cash effect in the form of lower interest payments. Further to the extended cash runway, we have also improved our funding options going forward, even if we have no imminent need for new capital. Following the positive development in our market capitalization as a result of MSD’s option exercise, we were able to amend our Form F-3 shelf registration and ATM facility. This potentially allows for flexible and cost-effective funding on optimal terms for Evaxion and our shareholders until March 2028. If and when funding needs should arise, we will be able to issue up to $45.5 million worth of Evaxion shares if and when market conditions allow during the coming three years. Full year 2025 financial results The financial results for the year 2025 showed a net loss of $7.7 million, an improvement of $2.9 million compared to 2024, driven by higher revenue and lower operating expenses. Throughout 2025, we have delivered and executed according to our financial strategy, resulting in improved equity, lower leverage and extended cash runway. Revenue for the year 2025 of $7.5 million relates to the MSD option exercise as well as the grant received from the Gates Foundation. With the out-licensing of EVX-B3 to MSD, all future development costs of the program will be carried by MSD, while the deal provides Evaxion with future revenue income potential of up to $592 million through milestone payments. Research and development (R&D) expenses were $10.0 million for the year 2025, which is according to plan for the year, and slightly lower than the $10.5 million as shown for 2024. The lower R&D costs are mainly related to reduced external services and expenses. General and administrative expenses were $6.8 million for the full year 2025, compared to $7.6 million in 2024. The decrease is primarily driven by lower capital market transaction costs. Net financial income of $0.6 million is driven by $2.6 million financial income due to the share price premium from the EIB debt-to-equity conversion finalized in July 2025, and $2.4 million financial expense due to remeasurement of the derivative liability from the January 2025 public offering investor warrants. Cash and cash equivalents as of December 31, 2025, were $23.2 million, compared to $6.0 million as of December 31, 2024, a significant strengthening achieved through out-licensing deal with MSD, debt-to-equity conversion with EIB, ATM facility and capital market activity. Total equity amounts to $17.0 million as of December 31, 2025, which is a significant improvement compared to a negative equity of $1.7 million as of December 31, 2024. Evaxion A/S Consolidated Statement of Financial Position Data (USD in thousands) Evaxion A/S Consolidated Statement of Comprehensive Loss Data (USD in thousands, except per share data) Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Investor releaseQuarter not tagged2026-03-02

Evaxion to announce business update and full year 2025 financial results on March 5, 2026

GlobeNewswire
COPENHAGEN, Denmark, March 2, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its full year 2025 financial results on Thursday March 5, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “s…Read full document

COPENHAGEN, Denmark, March 2, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will provide a business update and report its full year 2025 financial results on Thursday March 5, 2026, before opening of the Nasdaq CM. Evaxion’s Executive Management will host a conference call and webcast the same day at 14:30 CET/08:30 EST, presenting the update and results as well as taking questions. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion is a pioneering TechBio company based upon its proprietary, clinically validated and scalable AI platform, AI-Immunology™. The platform harnesses the power of artificial intelligence to decode the human immune system and develop novel vaccine candidates for cancer and infectious diseases. With AI-Immunology™ we conduct rapid, efficient and high-quality target discovery, drug design and development. Our team of +40 experts covers the entire value chain from target discovery to clinical development We have developed a clinical pipeline of both personalized and off-the-shelf cancer vaccine candidates as well as prophylactic vaccine candidates for infectious diseases. All our candidates address high unmet medical needs, reflecting our commitment to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion, AI-Immunology™ and our pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For a further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

Investor releaseQuarter not tagged2025-11-06

Evaxion announces business update and third quarter 2025 financial results

GlobeNewswire
COPENHAGEN, Denmark, November 6, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces third quarter 2025 financial results. Business highlights (since last quarterly update) Evaxion has seen tremendous progress in recent months with several massive achievements. We maintain a high activity level and continue to execute our plans. Highlights include: Evaxion’s Board of Directors has appointed Dr Helen Tayton-Martin as new CEO, effective November 24, 2025. Dr Tayton-Martin brings more than 30 years of experience, including biotech M&A, business development and operations. Unprecedented data from the phase 2 trial with personalized cancer vaccine EVX-01 in advanced melanoma patients presented on stage at the European Society for Medical Oncology (ESMO) Congress, one of the most prestigious medical oncology conferences in the world. We continue to enhance and expand our AI-Immunology™ platform, most recently with the addition of an automated vaccine design module replacing previous manual vaccine design processes. EVX-B3, the bacterial vaccine candidate now out-licensed to MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA), was discovered with AI-Immunology™, making it the first AI-designed vaccine candidate ever to be licensed by a pharmaceutical company. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million. Evaxion’s cash runway has been extended to the second half of 2027 from previously first half of 2027 following the payment from MSD and cash raised from capital market activities in September and October totaling $7.2 million. “We are really pleased with our achievements in recent months which have validated both our technology and strategy as well as significantly strengthened our position for future value creation. The impressive EVX-01 data shows our capabilities in cancer vaccines and the out-licensing of EVX-B3 confirms them in infectious disease vaccines. This is very important as we maintain a number of partnership discussions across disease areas and our AI-Immunology™ platform,” says Birgitte Rønø, CSO and interim CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, pres…Read full document

COPENHAGEN, Denmark, November 6, 2025 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, provides business update and announces third quarter 2025 financial results. Business highlights (since last quarterly update) Evaxion has seen tremendous progress in recent months with several massive achievements. We maintain a high activity level and continue to execute our plans. Highlights include: Evaxion’s Board of Directors has appointed Dr Helen Tayton-Martin as new CEO, effective November 24, 2025. Dr Tayton-Martin brings more than 30 years of experience, including biotech M&A, business development and operations. Unprecedented data from the phase 2 trial with personalized cancer vaccine EVX-01 in advanced melanoma patients presented on stage at the European Society for Medical Oncology (ESMO) Congress, one of the most prestigious medical oncology conferences in the world. We continue to enhance and expand our AI-Immunology™ platform, most recently with the addition of an automated vaccine design module replacing previous manual vaccine design processes. EVX-B3, the bacterial vaccine candidate now out-licensed to MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA), was discovered with AI-Immunology™, making it the first AI-designed vaccine candidate ever to be licensed by a pharmaceutical company. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million. Evaxion’s cash runway has been extended to the second half of 2027 from previously first half of 2027 following the payment from MSD and cash raised from capital market activities in September and October totaling $7.2 million. “We are really pleased with our achievements in recent months which have validated both our technology and strategy as well as significantly strengthened our position for future value creation. The impressive EVX-01 data shows our capabilities in cancer vaccines and the out-licensing of EVX-B3 confirms them in infectious disease vaccines. This is very important as we maintain a number of partnership discussions across disease areas and our AI-Immunology™ platform,” says Birgitte Rønø, CSO and interim CEO of Evaxion. Conference call and webcast Evaxion’s Executive Management will host a conference call and webcast at 8.30 ET/14.30 CET today, presenting the business update and financial results as well as taking questions. This event is free, open to the public and encouraged. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique PIN code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available on our website shortly after the event. Research & Development (R&D) update Evaxion has a R&D pipeline of innovative vaccine candidates for both cancer and infectious diseases. Our lead asset is the personalized cancer vaccine EVX-01. Developed with AI-Immunology™, it is designed to target multiple neoantigens; cancer unique proteins arising from mutations. We have now completed the initially planned two-years of treatment in the phase 2 trial with EVX-01 in patients with advanced melanoma (skin cancer) with very encouraging results. The two-year data demonstrated an Objective Response Rate (ORR) of 75% as 12 out of 16 patients had objective clinical responses, with four patients obtaining a complete response. The ORR is even higher than the 69% observed after one year of treatment. Additionally, a durable clinical benefit was observed as 92% of patients were still responding at two years follow-up and no relapses were observed. 54% of patients had a deepened response during treatment, improving from stable disease or partial response to partial or complete response. Tumor reduction (target lesions) was observed in 15 out of the 16 patients enrolled in the trial. In the trial, EVX-01 induced an immune response in all patients, with 81% of the targeted neoantigens generating potent specific T-cell responses. This high immunogenicity rate stands out as highly encouraging compared to historical observations and compares very favorably to what is seen with other approaches. These results also underline and validate the precision of the AI-Immunology™ platform in accurately identifying neoantigens, which leads to detectable signals in patients. Data also confirmed EVX-01 to be a well-tolerated treatment. All in all, the data clearly supports further clinical development of EVX-01, for which we are actively looking for a partner. The phase 2 trial goes on with a one-year extension for a subset of patients to further strengthen EVX-01’s already encouraging data package. The data was presented in an oral presentation at the ESMO conference, a strong testament to the interest in EVX-01 and the field of personalized cancer vaccines in general. We were present throughout the conference to interact and discuss with all interested stakeholders, including potential business partners. We have recently expanded our pipeline with EVX-04, a novel vaccine candidate targeting multiple non-conventional ERV tumor antigens, developed with AI-Immunology™. We will pursue clinical development of EVX-04, currently in preclinical development, as a new therapeutic vaccine against acute myeloid leukemia (AML). EVX-04 is designed to target non-conventional ERV (endogenous retrovirus) tumor antigens from the dark genome. These antigens are present in tumors but absent in normal tissue, making them highly attractive targets for cancer vaccines. Leveraging our proprietary AI-Immunology™ platform, Evaxion has identified ERV antigens in patient tumor sequencing data. Uniquely, the platform then selects optimal fragments from these antigens based on their potential to be effective vaccine targets across a wide range of patients. By including multiple of these fragments in EVX-04, the vaccine is designed to be effective in all patients regardless of immune and tumor ERV antigen differences. This makes EVX-04 a so-called off-the-shelf vaccine preproduced and ready for immediate administration after diagnosis. Data generated in the EVX-02 program has actively informed the development of both EVX-04 and EVX-03. As a matter of portfolio management, the EVX-02 program is now inactivated and removed from our R&D pipeline. Further to the advancement of our R&D pipeline, the continued development and improvement of AI-Immunology™ is also an important part of our R&D work. Most recently, we have developed an automated vaccine design module replacing previous manual vaccine design processes. Thus, AI-Immunology™, already superior in vaccine target discovery, now also enables enhanced design applicable for both new vaccines and optimization of approved ones. Automated design can both improve the quality of the vaccines and shorten the design time compared to manual methods from months to days, also carrying significant cost savings. The new module offers solutions for common problems encountered with traditional manual design methods, namely ensuring that vaccine targets can be properly expressed and obtained in the correct conformations. The new design module can be applied to new as well as existing vaccines thereby potentially enabling the development of new and improved generations of vaccines already in use. Further to our clinical progress, we also maintain a high level of preclinical activity with a number of active preclinical programs. Following the out-licensing of EVX-B3, the further development of this vaccine candidate is now in the hands of MSD and therefore removed from our R&D pipeline. We maintain the ambition of replenishing the pipeline with another infectious disease vaccine candidate, having already added EVX-B4 earlier this year. However, our priority will be to do this as part of a target discovery collaboration with an external partner. Business development update We were delighted by the out-licensing of EVX-B3, which validates Evaxion, the platform and our pipeline as well as our strategy for long-term value creation and monetization of our assets. We have received $7.5 million in option exercise fee and will be eligible for future payments of up to $592 million. MSD also holds an option to license EVX-B2, our Gonorrhea vaccine candidate. In September 2025 it was agreed to extend the evaluation period for EVX-B2. The extension follows an expansion of the initial evaluation plan encompassing further experiments. Consequently, a decision on potential in-licensing of EVX-B2 by MSD is now expected in the first half of 2026. Should MSD exercise the option on EVX-B2, we will receive a cash payment of $2.5 million and be eligible for future development, regulatory and sales milestone payments of up to $592 million as well as royalties on sales as for EVX-B3. The milestones are not additive per product to get to total deal value as some discount may occur if both programs progress successfully. We remain active in several parallel partnership discussions based on external interest in both our platform and pipeline as we continue to pursue our strategy of monetizing value through multiple partnerships. As has been the case throughout 2025, turmoil in financial markets and regulatory uncertainty impacts the decision processes with some potential partners, prolonging some discussions. Having concluded the deal on EVX-B3, we maintain the ambition of entering at least one more partnership deal in the coming months, even if uncertainty of timing is increasing. Cash runway extended On October 30, 2025, we announced the successful completion of different capital market activities, raising a gross total of $7.2 million. As a result, we now have cash on hand to fund our operations and R&D programs into the second half of 2027, extended from first half of 2027. The proceeds strengthened both Evaxion’s cash position and equity and followed the influx of $7.5 million paid by MSD when licensing EVX-B3. Of the $7.2 million, $4.5 million came from sales of shares in an at-the-market (ATM) offering and $2.7 million came from exercise of investor warrants. The latter reduced the number of outstanding warrants to purchase Evaxion ADSs by 1.0 million. The total number of outstanding warrants is now 2.8 million, including employee warrants, with a weighted average exercise price of $10.94. Third quarter 2025 financial results The third quarter showed strong financial performance with net income of $4.6 million, driven by revenue income from MSD’s option exercise and financial income from an 89% share price premium of the European Investment Bank’s (EIB’s) debt-to-equity conversion. The third quarter net income is a significant improvement compared to a net loss of $1.9 million for the same period 2024. Revenue of $7.5 million for the quarter ending September 30, 2025, primarily relates to MSD option exercise and also includes revenue recorded from Gates Foundation. With the out-licensing of EVX-B3 to MSD, all future development cost of the program will be carried by MSD, while the deal will provide Evaxion with future revenue income potential of up to $592 million through milestone payments. Research and development (R&D) expenses were $3.1 million for the period ending September 30, 2025, compared to $2.6 million last year. Project costs are more back-end loaded in 2025 compared to 2024, and overall, our expenses are well managed and within targets for the year. General and administrative expenses were $1.4 million for the third quarter 2025, compared to $2.1 million in 2024. The decrease is primarily driven by lower capital market transaction costs. Net financial income of $1.3 million is driven by $2.7 million financial income mainly due to the 89% share price premium from the EIB debt-to-equity conversion in July 2025, and $1.4 million financial expense mainly due to remeasurement of the derivative liability from investor warrants from our January 2025 public offering. During the third quarter of 2025 we continued strong execution of our financial strategy, resulting in improved equity, lower leverage and extended cash runway. Our cash runway has now been extended to second half of 2027, improved from earlier first half of 2027. Cash and cash equivalents as of September 30, 2025, were $10.6 million, compared to $6.0 million as of December 31, 2024. January to October 2025, we have received proceeds from capital market activity and recorded income of total $31.8 million, providing a significant improvement in our cash position. Total equity amounts to $16.6 million as of September 30, 2025, which is a significant improvement compared to a negative equity of $(1.7) million as of December 31, 2024. The equity is negatively impacted by $1.5 million as of September 30, 2025, arising from the net effect of the derivative liability from investor warrants issued as part of our January 2025 public offering. According to IAS/IFRS, the investor warrants are seen as derivative instruments, as the exercise price is denominated in USD while our company’s functional currency is DKK. Part of the proceeds from capital raises are consequently recognized as derivative liabilities. Reassessments are disclosed as financial income/expense and reverted to equity when warrants are exercised or lapse. The derivative liability from investor warrants has no impact on other items in the financial statement, hence Evaxion discloses the impact as a separate equity item. With the investor warrants exercised during October 2025, the net impact is expected to be reduced to a nominal impact by year end 2025. Evaxion’s equity and market capitalization remain well above Nasdaq’s requirements, with ample headroom expected to persist, as we continue to execute our financial strategy. Further, we will continue to focus and maintain our strict cost control and diligently prioritize and optimize our resource allocation. This enables us to absorb the general cost increase and inflation within the same cash spend as in 2024, e.g. we expect an operational cash burn of approximately $14 million in 2025. Evaxion A/S (Unaudited) Consolidated Statement of Financial Position Data (USD in thousands) Evaxion A/S (Unaudited) Consolidated Statement of Comprehensive Loss Data (USD in thousands, except per share data) Contact information Evaxion A/S Mads Kronborg Vice President, Investor Relations & Communication +45 53 54 82 96 [email protected] About Evaxion Evaxion A/S is a pioneering TechBio company based upon its AI platform, AI-Immunology™. Evaxion’s proprietary and scalable AI prediction models harness the power of artificial intelligence to decode the human immune system and develop novel immunotherapies for cancer, bacterial diseases, and viral infections. Based upon AI-Immunology™, Evaxion has developed a clinical-stage oncology pipeline of novel personalized vaccines and a preclinical infectious disease pipeline in bacterial and viral diseases with high unmet medical needs. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options. For more information about Evaxion and its groundbreaking AI-Immunology™ platform and vaccine pipeline, please visit our website. Forward-looking statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target,” “believe,” “expect,” “hope,” “aim,” “intend,” “may,” “might,” “anticipate,” “contemplate,” “continue,” “estimate,” “plan,” “potential,” “predict,” “project,” “will,” “can have,” “likely,” “should,” “would,” “could,” and other words and terms of similar meaning identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors, including, but not limited to, risks related to: our financial condition and need for additional capital; our development work; cost and success of our product development activities and preclinical and clinical trials; commercializing any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties including for conduct of clinical testing and product manufacture; our inability to enter into partnerships; government regulation; protection of our intellectual property rights; employee matters and managing growth; our ADSs and ordinary shares, the impact of international economic, political, legal, compliance, social and business factors, including inflation, and the effects on our business from other significant geopolitical and macro-economic events; and other uncertainties affecting our business operations and financial condition. For further discussion of these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F and other filings with the US Securities and Exchange Commission (SEC), which are available at www.sec.gov. We do not assume any obligation to update any forward-looking statements except as required by law.

As of 2026-08-22 • Updated weeklySource: Earnings sourceIngestion runbook