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Evaxion (NASDAQ: EVAX) advances EVX-04 AML vaccine with EHA 2026 data

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Rhea-AI Filing Summary

Evaxion A/S is highlighting progress on its EVX-04 cancer vaccine program by presenting new preclinical data at the EHA 2026 Congress. The poster on June 13, 2026 will cover the functional characterization of EVX-04, an off-the-shelf therapeutic vaccine candidate for acute myeloid leukemia.

Developed using Evaxion’s AI-Immunology™ platform, EVX-04 targets endogenous retrovirus tumor antigens that are present in AML tumors but not in normal tissue. In preclinical models, all 16 antigen fragments in EVX-04 trigger specific immune responses and prevent tumor growth, supporting its potential as a broadly applicable off-the-shelf vaccine.

The company states that these data are another step toward clinical testing and that it plans to submit a clinical trial application for EVX-04 in the second half of 2026. Background in the report underscores the high unmet need in AML, where survival rates remain low despite intensive and low-intensity chemotherapy options.

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EHA 2026 Congress dates June 11-14, 2026 European Hematology Association Congress in Stockholm where EVX-04 data will be presented
EVX-04 poster time June 13, 2026, 18:45-19:45 CET Scheduled poster session for EVX-04 functional characterization
Planned CTA timing Second half of 2026 Evaxion’s stated timing to submit a clinical trial application for EVX-04
Median AML diagnosis age 68 years Typical age at diagnosis for acute myeloid leukemia patients
Long-term survival younger fit AML patients 40% Overall survival rate with intensive chemotherapy and stem cell transplantation
Long-term survival fit older AML patients Less than 10% Overall survival with intensive treatment in fit older AML patients
Three-year survival with low-intensity AML therapy 25% Reported three-year overall survival for patients unfit for intensive treatment
EVX-04 ERV fragments 16 fragments Number of endogenous retrovirus antigen fragments included in the EVX-04 vaccine
AI-Immunology™ platform technical
"Evaxion A/S … developing novel vaccines with its pioneering AI-Immunology™ platform"
off-the-shelf therapeutic vaccine medical
"EVX-04, an off-the-shelf therapeutic acute myeloid leukemia (AML) vaccine"
endogenous retrovirus (ERV) tumor antigens medical
"EVX-04 targets non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome"
acute myeloid leukemia medical
"an AI-designed off-the-shelf cancer vaccine targeting endogenous retroviral antigens in acute myeloid leukemia"
A fast‑moving blood cancer that starts in the bone marrow and crowd out healthy blood cell production, leaving the body short of normal red cells, white cells and platelets. It matters to investors because the disease creates urgent medical need, drives demand for new diagnostics and treatments, and so clinical trial results, regulatory decisions and drug pricing can rapidly change the commercial prospects and valuation of companies working on therapies.
clinical trial application regulatory
"Evaxion plans to submit a clinical trial application in the second half of 2026"
An application submitted to a regulatory authority requesting formal permission to begin testing a new drug, medical device, or treatment in humans. Like asking for a building permit before construction, it summarizes safety data, plans for how the study will be run, and monitoring procedures; investors watch these filings closely because approval lets a program move from lab research to clinical testing, reducing uncertainty and creating value-driving milestones.
TechBio company financial
"Evaxion A/S … a clinical-stage TechBio company developing novel vaccines"
Form 6-K: How Foreign Companies Report to the SEC →
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of May 2026

Commission File Number: 001-39950

Evaxion A/S
(Exact Name of Registrant as Specified in Its Charter)

Dr. Neergaards Vej 5f
DK-2970 Hoersholm
Denmark
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F [ X ]      Form 40-F [   ]

INCORPORATION BY REFERENCE

This report on Form 6-K shall be deemed to be incorporated by reference in Evaxion A/S’s registration statements on Form S-8 (File No. 333-255064), on Form F-3 (File No. 333-265132), on Form F-1, as amended (File No. 333-266050), Form F-1 (File No. 333-276505), Form F-1 (File No. 333-279153), Form F-1 (File No. 333-283304), and Form F-3 (File No. 333- 285778), including any prospectuses forming a part of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Press Release

On May 12, 2026, Evaxion A/S (the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, issued a press release titled "Evaxion to present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia, at the EHA 2026 Congress". A copy of the press release is furnished as Exhibit 99.1 to this report on Form 6-K.

Exhibits

Exhibit No. Description
   
99.1 Evaxion to present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia, at the EHA 2026 Congress

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

   Evaxion A/S
   (Registrant)
    
   
Date: May 12, 2026 By:/s/ Helen Tayton-Martin    
   Helen Tayton-Martin
   Chief Executive Officer
   

EXHIBIT 99.1

Evaxion to present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia, at the EHA 2026 Congress

  • Data will reflect the functional characterization of EVX-04
  • Poster presentation on June 13, 2026

COPENHAGEN, Denmark, May 12, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, will announce the functional characterization of EVX-04, an off-the-shelf therapeutic acute myeloid leukemia (AML) vaccine, in a poster presentation at the European Hematology Association (EHA) 2026 Congress taking place in Stockholm, Sweden, June 11-14, 2026.

The new preclinical data will represent another step towards clinical testing of EVX-04. Evaxion plans to submit a clinical trial application in the second half of 2026.

“We are happy with the progression of the EVX-04 program and are looking forward to sharing new data at the EHA 2026 Congress, one of the most important events in the hematology field. This will be a great opportunity for us to discuss the data and development plans for EVX-04 with both scientific experts and potential business partners,” says Birgitte Rønø, CSO & COO of Evaxion.

Presentations details:
Abstract title: Preclinical characterization of EVX-04, an AI-designed off-the-shelf cancer vaccine targeting endogenous retroviral antigens in acute myeloid leukemia
Poster#: PS2306
Session: Poster session 2
Date/Time: June 13, 2026, at 18:45-19:45 CET/12:45-13:45 ET                 
Presenter: Søren Vester Kofoed, Research Scientist at Evaxion

About EVX-04
Developed with our AI-Immunology™ platform, EVX-04 targets 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 therapeutic cancer targets.

Using sequencing data from AML patients, our 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 antigens fragments discovered, AI-Immunology™ combined and selected 16 optimal sets of ERV fragments based on their cross-patient relevance and immunogenic potential. All 16 ERV fragments included in EVX-04 elicit a specific immune response and EVX-04 prevents tumor growth in preclinical tumor models.

The data-driven target selection ensures that EVX-04 provides broad tumor coverage regardless of immune and tumor ERV antigen differences across patients. Thus, EVX-04 is developed as an off-the-shelf vaccine preproduced and ready for immediate administration after diagnosis. The same concept is broadly applicable across cancers where immunotherapies remain inadequate and conserved immunogenic antigens can be identified.

About AML
AML is an aggressive hematologic malignancy characterized by the clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. The malignant proliferation leads to suppression of normal hematopoiesis, resulting in cytopenia, increased susceptibility to infections, bleeding, and fatigue (Döhner et al. 2022).

AML is the most frequent leukemia. It occurs across all age groups; however, it is predominantly a disease observed in older adults with a median age at diagnosis of 68 years.

Approximately 50% of AML patients are considered fit for intensive chemotherapy and stem cell transplantation. This combination is associated with a long-term overall survival rate of only 40% in younger patients and less than 10% in fit older patients.

For the approximately 50% not fit for intensive treatment, typically the elderly, the standard of care is low-intensity chemotherapy. Remissions are, however, short lived with a 3‐year overall survival rate at only 25% reported (Kantarjian et al. 2025).

Contact information 
Evaxion A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion.ai

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. 

Source: View Original Filing on SEC EDGAR

FAQ

What did Evaxion (EVAX) announce about its EVX-04 AML vaccine?

Evaxion announced it will present new preclinical data on EVX-04, an AI-designed, off-the-shelf therapeutic vaccine for acute myeloid leukemia, at the EHA 2026 Congress, focusing on functional characterization that supports future clinical development plans.

When and where will Evaxion (EVAX) present new EVX-04 data?

Evaxion will present EVX-04 data at the European Hematology Association 2026 Congress in Stockholm. The poster session is scheduled for June 13, 2026, from 18:45-19:45 CET, highlighting functional characterization of the AML vaccine candidate.

How does Evaxion’s AI-Immunology platform support EVX-04 development?

Evaxion’s AI-Immunology platform identifies endogenous retrovirus tumor antigens from AML patient sequencing data, then selects 16 optimal antigen fragments for EVX-04. These fragments aim to provide broad tumor coverage and elicit specific immune responses in preclinical models, enabling an off-the-shelf vaccine design.

What are Evaxion’s (EVAX) next steps for the EVX-04 AML program?

Evaxion states that the new preclinical data are another step toward clinical testing of EVX-04 and plans to submit a clinical trial application in the second half of 2026, advancing the candidate from preclinical research toward first-in-human evaluation.

Why is there high unmet medical need in AML targeted by EVX-04?

Acute myeloid leukemia has poor long-term outcomes despite intensive chemotherapy and stem cell transplantation. Long-term survival is about 40% in younger fit patients, less than 10% in fit older patients, and three-year survival near 25% with low-intensity therapy, underscoring the need for new treatments.

What makes EVX-04 an off-the-shelf therapeutic vaccine?

EVX-04 uses 16 predefined endogenous retrovirus antigen fragments selected for cross-patient relevance and immunogenicity. Because these antigens are conserved across many AML patients, the vaccine can be preproduced and administered immediately after diagnosis, rather than being customized for each individual.

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