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 December 2024
Commission File Number: 001-39950
Evaxion Biotech 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 Biotech 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), and Form F-1 (File No. 333-279153), 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of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 December 9, 2024, Evaxion Biotech A/S (the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, issued a press release titled “Evaxion announces 2025 milestones reflecting continued strong strategy execution”. A copy of the press release is furnished as Exhibit 99.1 to this report on Form 6-K.
Exhibits
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 Biotech A/S |
| | | (Registrant) |
| | | |
| | | |
Date: December 9, 2024 | | By: | /s/ Christian Kanstrup |
| | | Christian Kanstrup |
| | | Chief Executive Officer |
| | | |
EXHIBIT 99.1
Evaxion announces 2025 milestones reflecting continued strong strategy execution
- With most of Evaxion’s strategic milestones for 2024 now successfully achieved, the company announces milestones for 2025
- The 2025 key milestones reflect all parts of Evaxion’s strategy for value realization
- Evaxion expects to discuss the milestones at an investor event in the first quarter of 2025
COPENHAGEN, Denmark, December 9, 2024 - Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion”), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, announces its strategic milestones for 2025 after having now achieved almost all the milestones set for 2024.
The 2025 milestones reflect Evaxion’s high activity level, broad pipeline and strong external interest in potential partnerships around both our AI-Immunology platform and pipeline assets. As such, the milestones underscore our continued anticipated strategic progress.
“We have been very successful in executing our strategy and plans throughout 2024. This makes us excited and confident looking into 2025, as reflected in the milestones for the year. In essence, our strategy for value creation is unchanged and so is our daily focus on executing this strategy to the benefit of shareholders, patients and employees,” says Christian Kanstrup, CEO of Evaxion.
Evaxion’s overriding priorities are execution upon our business development strategy, continuation of the ongoing EVX-01 phase 2 trial, the ongoing strengthening of our AI-Immunology platform and further advancement of our research activities, including progressing our ERV-based precision vaccine concept towards clinical development. Finally, the focus is, of course, on advancing our existing partnerships, including bringing the MSD collaboration, entered in September 2024, to option exercise.
All this is reflected in the 2025 milestones as listed below. Evaxion expects to discuss the milestones at an investor event in the first quarter of 2025.
| Milestones | Target |
AI-Immunology | Launch of automated lead vaccine candidate design module | H2 |
Business development and partnerships | At least two new agreements | 2025 |
EVX-01 | All patients completed EVX-01 dosing | H1 |
EVX-01 | Supplemental phase 2 biomarker and immunogenicity data | H1 |
EVX-01 | Two-year phase 2 clinical efficacy readout | H2 |
Precision ERV cancer vaccines | Selection of lead vaccine candidate | H2 |
MSD vaccine collaboration (EVX-B2/EVX-B3) | MSD option exercise, up to USD 10 million option exercise fee | H2 |
EVX-V1 | Lead antigens selected for CMV vaccine candidate | H2 |
Infectious diseases | Two new pipeline candidates | 1 in H1, 1 in H2 |
Contact information
Evaxion Biotech A/S
Mads Kronborg
Vice President, Investor Relations & Communication
+45 53 54 82 96
mak@evaxion-biotech.com
About EVAXION
Evaxion Biotech 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 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 U.S. 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.
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