Evaxion (NASDAQ: EVAX) reports new EVX-04 AML vaccine preclinical data

Rhea-AI Filing Summary

Evaxion A/S reports new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine candidate for acute myeloid leukemia (AML), developed with its AI-Immunology™ platform. The data show EVX-04 is fully expressed and secreted in human cells, enabling immune recognition and activation.

All endogenous retrovirus antigens included in EVX-04 trigger specific immune responses in mice and human cells with different immune profiles, leading to targeted cell-killing and prevention of tumor growth in preclinical models. The results will be presented in a poster at the European Hematology Association 2026 Congress, and Evaxion is preparing a regulatory filing for clinical testing.

Key Figures

ERV fragments discovered: 5 million fragments ERV fragments in EVX-04: 16 fragments Median AML diagnosis age: 68 years +3 more

6 metrics

ERV fragments discovered 5 million fragments Identified by AI-Immunology platform from AML patient sequencing data

ERV fragments in EVX-04 16 fragments Selected optimal ERV fragment sets included in the vaccine

Median AML diagnosis age 68 years AML predominantly observed in older adults

Patients unfit for intensive treatment Approximately 50% Share of AML patients typically receiving low-intensity chemotherapy

Three-year AML overall survival 25% Reported 3-year overall survival rate under current care

Evaxion expert team size 40+ experts Covers value chain from target discovery to clinical development

Key Terms

AI-Immunology™, endogenous retrovirus (ERV) tumor antigens, dark genome, off-the-shelf therapeutic vaccine, +2 more

6 terms

AI-Immunology™ technical

"a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform"

ai-immunology™ is the use of artificial intelligence techniques to analyze immune system data and guide the discovery, design and testing of immune-based diagnostics, vaccines and therapies. It matters to investors because it can speed up research, reduce costs and reveal promising drug targets that traditional methods might miss—like using a powerful search engine to find a few needles in a vast haystack of biological signals—potentially increasing the chance and pace of commercial returns.

endogenous retrovirus (ERV) tumor antigens medical

"EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome"

dark genome technical

"EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome"

off-the-shelf therapeutic vaccine medical

"EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML)"

acute myeloid leukemia (AML) medical

"an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML)"

A fast‑growing cancer of the blood and bone marrow in which abnormal cells crowd out healthy blood cells, leading to infections, bleeding and fatigue; think of it as aggressive weeds rapidly taking over a garden. It matters to investors because the size, severity and unmet need of this condition drive demand for new drugs, influence clinical trial and regulatory outcomes, and determine revenue and risk for companies developing therapies.

hematologic malignancy medical

"AML is an aggressive hematologic malignancy characterized by clonal expansion of undifferentiated myeloid precursor cells"

A hematologic malignancy is a cancer that starts in the blood, bone marrow, or lymph system — places that make and carry blood cells — such as leukemia, lymphoma, or myeloma. Investors care because these diseases drive demand for diagnostic tests, drugs and treatments, clinical trial outcomes, and regulatory decisions; think of it like a widespread engine problem in a car model that creates a market for repairs, recalls and replacement parts, affecting companies’ prospects and revenues.

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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 June 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 June 11, 2026, Evaxion A/S (the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, issued a press release titled "Evaxion presents new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia". 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 presents new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia

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: June 11, 2026		By:	/s/ Helen Tayton-Martin
			Helen Tayton-Martin
			Chief Executive Officer

EXHIBIT 99.1

Evaxion presents new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia

• EVX-04 is successfully expressed and secreted in human cells enabling immune recognition and activation
• The vaccine antigens drive specific immune responses across different human immune profiles and induce targeted cell-killing
• Poster presentation at the European Hematology Association (EHA) 2026 Congress, taking place in Stockholm, Sweden
  

COPENHAGEN, Denmark, June 11, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel vaccines with its pioneering AI-Immunology™ platform, announces new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML). Developed with AI-Immunology™, EVX-04 targets multiple non-conventional endogenous retrovirus (ERV) tumor antigens from the dark genome.

The new 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.

Data will be presented at a poster presentation at the European Hematology Association (EHA) 2026 Congress taking place in Stockholm, Sweden, on June 13, 2026.

“We are excited to share the new data on EVX-04, which could potentially greatly improve treatment options for AML patients. We are successfully executing the preclinical activities and in parallel preparing the regulatory filing for clinical testing and are looking forward to discussing the data and the program at the EHA congress,” says Birgitte Rønø, CSO & COO of 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 antigen 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 pre-produced 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 clonal expansion of undifferentiated myeloid precursor cells (AML blasts) in the bone marrow. It has poor outcomes for patients ineligible for intensive chemotherapy or stem cell transplantation, highlighting the need for novel and less toxic treatment strategies.

AML is the most frequent leukemia, occurring across all age groups, however, predominantly observed in older adults (median age at diagnosis of 68 years).

Approximately 50% of patients, typically the elderly, are not fit for intensive treatment, so 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. 

FAQ

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

Evaxion announced new preclinical data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia. The data show full expression and secretion in human cells, immune activation, and targeted tumor cell-killing in preclinical models, supporting preparation for a regulatory filing for clinical testing.

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

Evaxion’s AI-Immunology™ platform identified endogenous retrovirus tumor antigens from AML patient sequencing data and narrowed five million fragments to 16 optimal ERV fragments. These were selected for cross-patient relevance and immunogenic potential, aiming for broad tumor coverage regardless of patient immune and ERV antigen differences.

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

EVX-04 targets ERV antigens that are selectively expressed in tumors but absent in normal tissue, allowing a fixed antigen set usable across patients. It is designed as a pre-produced vaccine, ready for immediate administration after diagnosis, rather than being personalized for each individual patient.

What unmet medical need in AML is Evaxion targeting with EVX-04?

Acute myeloid leukemia has poor outcomes for patients unfit for intensive chemotherapy or stem cell transplant. Roughly half of patients, often older adults, receive low-intensity chemotherapy, with short remissions and a reported three-year overall survival of only 25%, underscoring need for novel treatments.

Where and when will Evaxion present the new EVX-04 preclinical data?

Evaxion will present the EVX-04 data in a poster at the European Hematology Association 2026 Congress. The congress is taking place in Stockholm, Sweden, with the specific poster presentation scheduled for June 13, 2026, providing a scientific forum to discuss the program and findings.

What stage of development is Evaxion’s EVX-04 vaccine program in?

EVX-04 is in the preclinical stage, with data showing immune activation and tumor growth prevention in models. Evaxion reports it is successfully executing preclinical activities while in parallel preparing the regulatory filing required to begin clinical testing of this AML therapeutic vaccine candidate.

Filing Exhibits & Attachments

1 document

Press Releases

• EX-99.1 PRESS RELEASE 8.5 KB