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Evaxion: EVX-04 prevents tumor growth in preclinical models

The poster will detail EVX-04's design, which selected 16 optimal sets from five million discovered ERV antigen fragments.

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Form Type
6-K

Rhea-AI Filing Summary

Evaxion A/S will present new target-validation data for EVX-04 at the American Society of Hematology Annual Meeting and Exposition in New Orleans, December 12–15, 2026. The company says the data show broad patient coverage, conserved target expression across AML disease stages, and ERV-specific T-cell responses in humanized mice. The poster is scheduled for December 13.

EVX-04 is described as an off-the-shelf therapeutic vaccine candidate for acute myeloid leukemia. Evaxion says its AI-Immunology platform identified five million ERV antigen fragments and selected 16 optimal sets of fragments. The company also says all 16 ERV fragments included in EVX-04 elicit a specific immune response and prevent tumor growth in preclinical models. Daniela Kleine-Kohlbrecher, Director, Immuno-oncology, is listed as the presenter.

Filing Explained

The 6-K also makes this announcement part of Evaxion’s specified registration statements—S-8 333-255064; F-3 333-265132 and 333-285778; and F-1 333-266050, 333-276505, 333-279153 and 333-283304—from November 4, 2026, unless later filings supersede it.

ERV antigen fragments identified 5 million fragments Identified using the AI-Immunology platform
Optimal ERV-fragment sets selected 16 sets Selected for EVX-04
ASH meeting dates December 12–15, 2026 American Society of Hematology Annual Meeting and Exposition
Poster presentation December 13, 2026, 6:00–8:00 p.m. ET Poster number 4310; session 801
endogenous retrovirus (ERV) tumor antigens medical
"non-conventional endogenous retrovirus (ERV) tumor antigens"
dark genome technical
"ERV tumor antigens from the dark genome"
humanized mice medical
"induction of ERV-specific T-cell responses in humanized mice"
off-the-shelf therapeutic vaccine medical
"an off-the-shelf therapeutic vaccine for acute myeloid leukemia"

FAQ

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When will EVAX present EVX-04 data at ASH 2026?

The poster is scheduled for Sunday, December 13, 2026, from 6:00–8:00 p.m. ET, at the Ernest N. Morial Convention Center, Hall F. It is poster number 4310 in session 801, “Gene Therapies: Poster.”

What did EVAX report about EVX-04?

Evaxion said the data show broad patient coverage, conserved target expression across AML disease stages, and ERV-specific T-cell responses in humanized mice.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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 November 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 November 4, 2026, Evaxion A/S (the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, issued a press release titled "Evaxion will present new target validation data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia at ASH 2026 Meeting". A copy of the press release is furnished as Exhibit 99.1 to this report on Form 6-K.

Exhibits 

Exhibit Number Description
   
99.1 Evaxion will present new target validation data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia at ASH 2026 Meeting


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: November 4, 2026 By:/s/ Helen Tayton-Martin    
   Helen Tayton-Martin
   Chief Executive Officer
   

EXHIBIT 99.1

Evaxion will present new target validation data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia at ASH 2026 Meeting

  • The data further validate the potential of EVX-04 as an off-the-shelf therapeutic vaccine for acute myeloid leukemia
  • Data will be presented in a poster session at the American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, December 12-15, 2026

COPENHAGEN, Denmark, November 4, 2026 - Evaxion A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company developing novel immunotherapies with its pioneering AI-Immunology™ platform, will present new data for EVX-04, an off-the-shelf therapeutic vaccine for acute myeloid leukemia (AML), in a poster session at the American Society of Hematology (ASH) Annual Meeting and Exposition in New Orleans, Louisiana, December 12-15, 2026.

The data further validate the potential of EVX-04 as an off-the-shelf therapeutic vaccine for AML, demonstrating broad patient coverage, conserved target expression across disease stages and the induction of ERV-specific T-cell responses in humanized mice. The data build on preclinical findings presented at the ASH meeting 2025 demonstrating strong EVX-04 specific T-cell responses and inhibition of tumor growth in preclinical mouse models.

Poster presentation details:

  • Title: Validation of conserved ERV targets encoded by the off-the-shelf EVX-04 DNA vaccine for AML
  • Poster#: 4310
  • Session: 801. Gene Therapies: Poster II
  • Location: Ernest N. Morial Convention Center - Hall F
  • Date/Time: Sunday, December 13, 2026, 6:00-8:00pm ET / 00:00-02:00 (December 14) CET
  • Presenter: Daniela Kleine-Kohlbrecher, Director, Immuno-oncology, 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 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 prevent 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 existing 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 three‐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 clinical-stage 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 immunotherapies for cancer as well as infectious and autoimmune 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 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. 

Filing Exhibits & Attachments

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