# EDGAR Filing Document

**Accession Number:** 0001828253
**File Stem:** 0001171843-25-004705
**Filing Date:** 2025-7
**Character Count:** 10009
**Document Hash:** 9454eceebc1f0c7ca57683026a0d3004
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001171843-25-004705.hdr.sgml**: 20250725

**ACCESSION NUMBER**: 0001171843-25-004705

**CONFORMED SUBMISSION TYPE**: 6-K

**PUBLIC DOCUMENT COUNT**: 2

**CONFORMED PERIOD OF REPORT**: 20250725

**FILED AS OF DATE**: 20250725

**DATE AS OF CHANGE**: 20250725

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Evaxion A/S
- **CENTRAL INDEX KEY:** 0001828253
- **STANDARD INDUSTRIAL CLASSIFICATION:** BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** G7
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 6-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-39950
- **FILM NUMBER:** 251149873

**BUSINESS ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** DR NEERGAARDS VEJ 5F
- **CITY:** HOERSHOLM
- **PROVINCE COUNTRY:** G7
- **BUSINESS PHONE:** 4552656554

**MAIL ADDRESS:**
- **ADDRESS IS A NON US LOCATION:** YES
- **STREET 1:** DR NEERGAARDS VEJ 5F
- **CITY:** HOERSHOLM
- **PROVINCE COUNTRY:** G7

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Evaxion Biotech A/S
- **DATE OF NAME CHANGE:** 20201014

**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 July 2025**

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 ] &nbsp;&nbsp;&nbsp;&nbsp; Form 40-F [ ]

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**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 July 25, 2025, 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 two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025". A copy of the press release is furnished as Exhibit 99.1 to this report on Form 6-K.

**Exhibits**

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| | |
|:---|:---|
| <u>Exhibit No.</u> | <u>Description</u> |
| [99.1](exh_991.htm) | [Evaxion to present two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025](exh_991.htm) |

---

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**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.

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| | | |
|:---|:---|:---|
|  |  | <u>**Evaxion A/S**</u> |
|  |  | (Registrant) |
| Date: July 25, 2025 | By: | <u>/s/ Birgitte Rønø&nbsp;&nbsp;&nbsp;&nbsp;</u> |
|  |  | Birgitte Rønø |
|  |  | Interim Chief Executive Officer |

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## Exhibit 99.1

**EXHIBIT 99.1**

**Evaxion to present two-year clinical efficacy data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025**

COPENHAGEN, Denmark, July 25, 2025 - Evaxion A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, will be presenting two-year clinical efficacy data from its phase 2 trial with lead compound EVX-01 at the European Society for Medical Oncology (ESMO) Congress 2025 to be held in Berlin, Germany, from October 17-21, 2025.

Designed with Evaxion's AI-Immunology™ platform, EVX-01 is a personalized cancer vaccine currently being evaluated as a treatment for advanced melanoma (skin cancer). The trial has yielded numerous convincing data already, including interim one-year data presented at the ESMO Congress in September 2024. Data demonstrated a 69% Overall Response Rate, reduction in tumor target lesions in 15 out of 16 patients, and a positive correlation between the AI-Immunology™ platform predictions and immune responses induced by the individual neoantigens in the EVX-01 vaccine (p=0.00013).

"We are delighted to have the two-year data from the EVX-01 phase 2 trial accepted for presentation at the ESMO Congress 2025. As one of the most important and prestigious medical oncology conferences in the world, the congress will be a great place for us to present the data to a large audience, including potential partners," says Birgitte Rønø, CSO and interim CEO of Evaxion.

The phase 2 trial investigates EVX-01 in combination with MSD's (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy, KEYTRUDA® (pembrolizumab) in patients with advanced melanoma (skin cancer). Each patient enrolled in the trial has received a unique vaccine designed and manufactured based on their individual biology. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

**Presentation details**

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| | |
|:---|:---|
| Abstract Title: | EVX-01, a personalized cancer vaccine, induces potent T-cell responses and durable disease control in advanced melanoma: 2-year follow-up |
| Abstract#: | #6308 |
| Presentation#: | 1516MO |
| Track: | Mini oral session: Investigational immunotherapy |
| Location: | Nuremberg Auditorium - Hall 5.2 |
| Date/Time: | October 17 at 14:10 - 14:15 CEST |
| Presenter: | Dr. Muhammad Adnan Khattak, Director, Oncology, One Clinical Research, Hollywood Private Hospital & Edith Cowan University, Perth, WA, Australia |

---

**About EVX-01**

EVX-01 is a personalized peptide-based cancer vaccine intended for first-line treatment of multiple advanced solid cancers. It is Evaxion's lead clinical asset.

EVX-01 is a personalized therapy designed with our AI-Immunology™ platform and is tailored to target the unique tumor profile and immune characteristics of each patient. It engages the patient's immune system to fight off cancer by mounting a targeted response against tumors.

In the completed phase 1/2a clinical trial (NCT03715985), assessing EVX-01 in combination with a PD-1 inhibitor, eight of twelve metastatic melanoma patients (67%) had objective clinical responses, with two complete and six partial responses.

In addition, vaccine-induced T cells were detected in all patients and a significant correlation between clinical response and the AI-Immunology™ predictions was observed, underlining the predictive power of the platform.

**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 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 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.