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 March 2024

Commission File Number: 001-39950

Evaxion Biotech A/S
(Translation of registrant's name into English)

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) and Form F-1 (File No. 333-276505), 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of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.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 March 27, 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 Business Update and Full Year 2023 Financial Results”. 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 Press Release dated March 27, 2024


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: March 27, 2024 By:/s/ Christian Kanstrup    
   Christian Kanstrup
   Chief Executive Officer
   
EdgarFiling

EXHIBIT 99.1

Evaxion Announces Business Update and Full Year 2023 Financial Results

COPENHAGEN, Denmark, March 27, 2024 (GLOBE NEWSWIRE) -- Evaxion Biotech A/S (NASDAQ: EVAX) (“Evaxion” or the “Company”), a clinical-stage TechBio company specializing in developing AI-Immunology™ powered vaccines, today provides a business update and announces full year 2023 financial results.

Christian Kanstrup, Chief Executive Officer at Evaxion, commented: “We have made significant progress in our business and our financing strategies in recent months, notably the successful closing of our bridge financing round towards the end of 2023 and a subsequent public offering in early February 2024. We are very pleased with the MSD GHI participation in both financing rounds, following which we now have cash at hand into Q1 2025.”

Christian continues: “With our refined strategy centered around AI-Immunology™ focusing on value realization via Targets, Pipeline and Responders based upon a muti-partner approach, we are enthusiastic about the prospects this brings for 2024. Further, we are executing to progress our ambition to fund our projected $14 million operational cash burn for 2024 through revenue generated from our business development activities.”

Business Updates Since Last Quarterly Update

In January 2024, Evaxion announced it had commenced developing tailored novel cancer vaccines using the AI-Immunology™ platform. The initiative involves a new category of AI-identified tumor vaccine targets, ERVs, and aims to obtain preclinical Proof-of-Concept by the second half of 2024. With the AI-Immunology™ discovered novel cancer targets, designing personalized and precision vaccines may become feasible. This approach holds the potential to provide treatment solutions for cancer patients who typically do not respond to cancer immunotherapy.

In February 2024, the initial phases of an ongoing vaccine collaboration with MSD were successfully completed. The collaboration was initiated in September 2023, and in February 2024 MSD was revealed as the pharma partner for the EVX-B3 vaccine collaboration in connection with the collaboration update. The project aims to develop a vaccine against a bacterial pathogen responsible for a pressing global medical issue, lacking preventive or curative options.

Evaxion hosted an R&D Day on March 19, 2024, providing deeper insights into the validated and differentiated AI-Immunology™ platform. Key takeaway messages from the day were:

In the initial months of 2024, we showcased our differentiated AI-Immunology™ platform for vaccine target discovery, design and development, alongside our refined strategy for value generation, at the following conferences:

January 8-11:CEO Christian Kanstrup attended the 42nd annual J.P. Morgan Healthcare Conference.
February 27:Chief AI Officer, Andreas Holm Mattsson, participated in a panel discussion at the Sachs Associates 5th Annual European HealthTech CEO Forum.
February 28:CEO Christian Kanstrup presented the Sachs Associates 17th Annual European Life Sciences CEO Forum.
March 7:VP of AI & Innovation, Jens Kringelum, presented the 5th Biologics World Nordics 2024 Conference.
March 7:CEO Christian Kanstrup and CSO Birgitte Rønø participated in a fireside chat at the H.C. Wainwright 1st Annual Artificial Intelligence Based Drug Discovery & Development Virtual Conference.
March 7-8:Senior Project Manager, Immuno-oncology, Daniela Kleine-Kohlbrecher, presented at the 8th Annual MarketsandMarkets Next-Gen Immuno-Oncology Conference.

 

   
Anticipated 2024 Milestones
 MilestonesTarget
EVX-B1Conclusion of final MTA study with potential partnerQ1 2024
AI-Immunology™Launch of EDEN™ model version 5.0Mid 2024
EVX-B2-mRNAEVX-B2-mRNA preclinical Proof-of-Concept obtainedQ3 2024
EVX-01Phase 2 one-year readoutQ3 2024
EVX-B3Conclusion of target discovery and validation work in collaboration with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA)H2 2024
Precision ERV cancer vaccinesPreclinical Proof-of-Concept obtainedH2 2024
FundingAmbition for full year 2024 is to generate business development income equal to 2024 cash burn (excluding financing activities) of $14 million* 
* No assurances can be made that we will generate such business development income     

Full Year 2023 Financial Results

Based on the Company’s current cash position, with an estimated cash runway into February 2025 and the need for further funding, it is the assessment of management that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast

Evaxion will host a Business Update and Full Year 2023 Financial Results webcast on Tuesday, April 2, at 15:00 CEST / 9:00 a.m. EDT. To join the conference call, listen to the presentation and ask verbal questions, please register in advance via this link to receive the dial-in telephone numbers and a unique pin code. The call can be accessed 15 minutes prior to the start of the live event. To join the webcast, please click on this link. The webcast recording will be available shortly after the event.

 Evaxion Biotech A/S 
Consolidated Statement of Financial Position Data (Audited) 
(USD in thousands) 
  Dec 31,
2023 
Dec 31,
2022
 
Cash and cash equivalents $5,583 $13,184
Total assets 12,889 22,025
Total liabilities 17,618 13,722
Share capital 5,899 3,886
Other reserves 97,342 90,262
Accumulated deficit (107,970) (85,845)
Total equity (4,729) 8,303
Total liabilities and equity $12,889 $22,025


Evaxion Biotech A/S   
Consolidated Statement of Comprehensive Loss Data (Audited)   
(USD in thousands, except per share data)   
    
 Three Months Ended
December 31,

 Twelve Months Ended
December 31,

 2023 2022 2023 2022
        
            
Revenue$73 $ $73 $
Research and development (2,298) (4,073) (11,916) $(17,056)
General and administrative(2,138) (2,452) (10,354) (8,208)
        
Operating loss(4,363) (6,525) (22,197) (25,264)
Finance income559 70 963 2,831
Finance expenses(895) (590) (1,681) (1,508)
        
Net loss before tax$(4,699) $(7,045) $(22,915) $(23,941)
        
Income tax benefiT177 173 790 772
        
Net loss for the period$(4,522) $(6,872) $(22,125) $(23,169)
        
Net loss attributable to shareholders of Evaxion Biotech A/S$(4,522) $(6,872) $(22,125) $(23,169)
        
Loss per share – basic and diluted$(0.16) $(0.29) $(0.81) $(0.98)
Number of shares used for calculation (basic and diluted)29,061,036 24,082,247 27,335,829 23,638,685


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 Statements

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 the worldwide ongoing COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia and the Middle East; 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.  

Contact Information
 
Evaxion Biotech A/S
Christian Kanstrup        
Chief Executive Officer
cka@evaxion-biotech.com  
Source: Evaxion Biotech