UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549


FORM 6-K


REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO SECTION 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of May, 2021

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 offices)


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 Form 40-F ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐


INCORPORATION BY REFERENCE

Exhibits 99.1 and 99.2 of this report on Form 6-K shall be deemed to be incorporated by reference into the registration statement on Form S-8 (Registration Number 333-255064) of Evaxion Biotech A/S (the “Company”) (including any prospectus forming a part of such registration statement) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.

Furnished as Exhibits to this Report on Form 6-K is information regarding the Company’s financial results for the fiscal quarter ended March 31, 2021.


Exhibits

Exhibit

    

No.

Description

99.1

Unaudited Condensed Consolidated Interim Financial Statements.

99.2

Management’s Discussion and Analysis of Financial Condition and Results of Operations.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

14

Evaxion Biotech A/S

Date: May 14, 2021

By:

/s/ Glenn S. Vraniak

Glenn S. Vraniak

Chief Financial Officer


Table of Contents

Exhibit 99.1

EVAXION BIOTECH A/S

INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS

Page

Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss for the Three Months Ended March 31, 2021 and 2020

2

Unaudited Condensed Consolidated Interim Statements of Financial Position as of March 31, 2021 and December 31, 2020

3

Unaudited Condensed Consolidated Interim Statements of Changes in Equity for the Three Months Ended March 31, 2021 and 2020

4

Unaudited Condensed Consolidated Interim Statements of Cash Flows for the Three Months Ended March 31, 2021 and 2020

5

Notes to Unaudited Condensed Consolidated Interim Financial Statements

6

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Table of Contents

EVAXION BIOTECH A/S

Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss

Three Months Ended

March 31, 

    

2021

    

2020

(USD in thousands, except per

share amounts)

Operating expenses:

  

  

Research and development

$

3,893

$

2,510

General and administrative

 

1,282

 

781

Total operating expenses

 

5,175

 

3,291

Operating loss

 

(5,175)

 

(3,291)

Finance income

 

972

 

16

Finance expenses

 

(297)

 

(4)

Net loss before tax

 

(4,500)

 

(3,279)

Income tax benefit

 

407

 

180

Net loss for the period

$

(4,093)

$

(3,099)

Net loss attributable to shareholders of Evaxion Biotech A/S

$

(4,093)

$

(3,099)

Other comprehensive income that may be reclassified to profit or loss in subsequent periods:

 

  

 

  

Exchange differences on translation of foreign operations

 

29

 

Tax on other comprehensive income

 

(6)

 

Other comprehensive income that will not be reclassified to profit or loss in subsequent periods:

 

 

Exchange differences on currency translation to presentation currency

 

(758)

 

(180)

Other comprehensive loss for the period, net of tax

$

(735)

$

(180)

Total comprehensive loss

$

(4,828)

$

(3,279)

Total comprehensive loss attributable to shareholders of Evaxion Biotech A/S

$

(4,828)

$

(3,279)

Loss per share – basic and diluted

$

(0.23)

$

(0.20)

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

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Table of Contents

EVAXION BIOTECH A/S

Unaudited Condensed Consolidated Interim Statements of Financial Position

March 31, 

December 31, 

    

2021

    

2020

(USD in thousands)

ASSETS

Non-current assets

  

  

Intangible assets

$

96

$

100

Deferred tax assets

 

179

 

262

Property and equipment

 

1,600

 

221

Government grants receivables

 

133

 

194

Tax receivables

 

232

 

Leasehold deposits

 

193

 

238

Total non-current assets

 

2,433

 

1,015

Current assets

 

  

 

  

Prepayments and other receivables

 

3,901

 

1,971

Deferred offering costs

 

 

1,729

Leasehold deposits

 

19

 

Tax receivables

 

1,612

 

1,416

Cash and cash equivalents

 

26,955

 

5,834

Total current assets

 

32,487

 

10,950

TOTAL ASSETS

$

34,920

$

11,965

EQUITY AND LIABILITIES

 

  

 

  

Share capital

$

3,132

$

2,648

Other reserves

 

55,745

 

31,669

Accumulated deficit

 

(31,078)

 

(27,279)

Total equity

 

27,799

 

7,038

Non-current liabilities

 

  

 

  

Lease liabilities

 

1,053

 

Provisions

 

52

 

Total non-current liabilities

 

1,105

 

Current liabilities

 

  

 

  

Lease liabilities

 

55

 

20

Trade payables

 

3,408

 

2,646

Other payables

 

2,553

 

2,261

Total current liabilities

 

6,016

 

4,927

Total liabilities

 

7,121

 

4,927

TOTAL EQUITY AND LIABILITIES

$

34,920

$

11,965

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

3


Table of Contents

EVAXION BIOTECH A/S

Unaudited Condensed Consolidated Interim Statements of Changes in Equity

Other reserves

Foreign

currency

Share

Share

translation

Accumulated

Total

    

Note

    

capital

    

premium

    

reserve

    

deficit

    

equity

(USD in thousands)

Equity at December 31, 2020

  

$

2,648

$

31,443

$

226

$

(27,279)

$

7,038

Net loss for the period

  

 

 

 

 

(4,093)

 

(4,093)

Other comprehensive income

  

 

 

 

(729)

 

 

(729)

Tax effects on other comprehensive income

(6)

(6)

Share-based compensation

5

 

 

 

 

294

 

294

Issuance of shares for cash

  

 

484

 

29,516

 

 

 

30,000

Transaction costs

  

 

 

(4,705)

 

 

 

(4,705)

Equity at March 31, 2021

  

$

3,132

$

56,254

$

(509)

$

(31,078)

$

27,799

Other reserves

Foreign

currency

Share

Share

translation

Accumulated

Total

    

Note

   

capital

   

premium

   

reserve

   

deficit

   

equity

 

(USD in thousands)

Equity at December 31, 2019

 

  

$

2,481

$

22,862

$

(169)

$

(15,812)

$

9,362

Net loss for the period

 

  

 

 

 

 

(3,099)

 

(3,099)

Other comprehensive income

 

  

 

 

 

(180)

 

 

(180)

Share-based compensation

 

5

 

 

 

 

680

 

680

Equity at March 31, 2020

 

  

$

2,481

$

22,862

$

(349)

$

(18,231)

$

6,763

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

4


Table of Contents

EVAXION BIOTECH A/S

Unaudited Condensed Consolidated Interim Statements of Cash Flows

Three Months Ended

March 31, 

2021

2020

(USD in thousands)

    

    

    

Operating activities:

  

  

Net loss for the period

$

(4,093)

$

(3,099)

Adjustments for non-cash items

 

(978)

 

507

Interest paid

 

(2)

 

Cash flow from operating activities before changes in working capital

 

(5,073)

 

(2,592)

Cash flow from changes in working capital:

 

  

 

  

Changes in net working capital

 

1,038

 

(358)

Net cash used in operating activities

 

(4,035)

 

(2,950)

Investing activities:

 

  

 

  

Investment in intangible assets

 

(60)

 

Purchase of property, plant and equipment

 

(282)

 

(64)

Receipt (payment) of non-current financial assets – leasehold deposits

 

15

 

(17)

Net cash used in investing activities

 

(327)

 

(81)

Financing activities:

 

  

 

  

Proceeds from issuance of shares

 

27,900

 

Transaction costs related to issuance of shares

 

(2,605)

 

Leasing installments

 

(43)

 

(18)

Net cash provided by/ (used in) financing activities

 

25,252

 

(18)

Net increase/ (decrease) in cash and cash equivalents

 

20,890

 

(3,049)

Cash and cash equivalents at January 1

 

5,834

 

9,559

Exchange rate adjustments on cash and cash equivalents

 

231

 

(165)

Cash and cash equivalents at March 31

$

26,955

$

6,345

The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.

5


Table of Contents

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Note 1. General Company Information

Evaxion Biotech A/S (the “Company” or “Evaxion”) is an artificial intelligence (“AI”)-immunology platform company that uses its proprietary AI technology, engineering expertise and drug development know-how to simulate the human immune system and generate predictive models to identify and develop efficacious immunotherapies for patients in the global market. Unless the context otherwise requires, references to the “Company,” “we,” “us,” and “our”, refer to Evaxion Biotech A/S and its subsidiaries.

Evaxion is a public limited liability company incorporated and domiciled in Denmark with its registered office located at Dr. Neergaards Vej 5f, DK-2970 Hoersholm, Denmark.

The unaudited condensed consolidated interim financial statements of Evaxion Biotech and its subsidiary (collectively, the “Group”) for the three months ended March 31, 2021 and 2020, were approved, and authorized for issuance, by the Audit Committee of the board of directors on May 11, 2021.

Stock Split and bonus share issuance

On January 4, 2021, the Company’s board of directors and shareholders approved (i) a 2-for-1 stock split of its issued and outstanding ordinary shares and (ii) a bonus share issuance in the ratio of 17-for-1 of its issued and outstanding ordinary shares (collectively the “Stock Split”). The Stock Split also resulted in a reduction of the nominal value of the Company’s ordinary shares from DKK 2 to DKK 1. Accordingly, all share and per share data in the accompanying unaudited consolidated condensed interim financial statements, and notes thereto, have been retroactively adjusted for all periods presented, as applicable, to give effect to the stock split, the bonus share issuance and the reduction in nominal value of our ordinary shares, with the corresponding impact on share capital and share premium. Retrospective effect has also been given with respect to the share and per share data for the warrants and convertible debt instruments.

Initial Public Offering

On February 5, 2021, the Company completed an initial public offering (“IPO”), which resulted in the listing of American Depository Shares (“ADS”) representing the company’s ordinary shares, under the symbol “EVAX” in the United States on The NASDAQ Capital Market. The gross proceeds from the IPO were $30.0 million, and net proceeds were $27.9 million after deducting underwriting discounts and commissions and before deducting fees and expenses payable by the Company.

Note 2. Summary of Significant Accounting Policies

Basis of preparation

The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2020 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board.

The accounting policies applied are consistent with the accounting policies as outlined in the basis of presentation section included in Note 2 of the audited financial statements as of and for the year ended December 31, 2020. As of January 1, 2021, the following accounting policy in respect of foreign currency translation is now relevant:

Intragroup receivables to foreign operations for which settlement is neither planned nor likely to occur in the foreseeable future are treated as part of the net investment, and the gain or loss on foreign currency translation of such receivables is recognized in other comprehensive income and classified as part of the foreign currency translation reserve.

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Table of Contents

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and requires management to exercise its judgment in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3.

Deferred Offering Costs

Offering costs, consisting of legal, accounting, printer and filing fees of $2.6 million were directly attributable to the issuance of new shares relating to the Company’s IPO and were offset against proceeds from the IPO upon the effectiveness of the offering.

Standards issued but not yet effective

There were a number of standards and interpretations which were issued but were not yet effective at March 31, 2021 and have not been adopted for these financial statements, including:

Amendments to IAS 1 Presentation of Financial Statements: Classification of Liabilities as Current or Non-current (January 1, 2023)
Amendment to IAS 37 Provisions, contingent liabilities and contingent assets, Onerous Contracts— Cost of Fulfilling a Contract (January 1, 2022)
Amendments to IAS 16 Property, Plant and Equipment, proceeds before intended use (January 1, 2022)
Annual Improvements 2018-2020 (January 1, 2022)
Amendment to IAS 1 Presentation of Financial Statements: Disclosure of Accounting Policies (January 1, 2023)
Amendment to IAS 8 Accounting Policies, Changes in Accounting Estimates and Errors: Definition of Accounting Estimates (January 1, 2023)
Amendments to IFRS 16 Leases: Covid-19-Related Rent Concessions beyond June 30, 2021 (April 1, 2021)

The Company expects to adopt these standards, updates and interpretations when they become mandatory. These standards are not expected to have a significant impact on disclosures or amounts reported in the Company’s financial statements in the period of initial application and future reporting periods.

Note 3. Significant Accounting Judgements, Estimates, and Assumptions

In the application of our accounting policies, the Company is required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates.

The estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods.

The unaudited condensed consolidated interim financial statements do not include all disclosures for critical accounting judgments and estimation uncertainties that are required in the annual consolidated financial statements, and therefore, should be read in conjunction with the Company’s audited consolidated financial statements as of and for the year ended December 31, 2020.

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Table of Contents

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Significant accounting estimates made in the process of applying our accounting policies and that have the most significant effect on the amounts recognized in our unaudited condensed consolidated interim financial statements relate to share-based compensation. See Note 5 below for additional information regarding stock-based compensation.

There have been no other changes to the application of critical accounting judgments, or estimation uncertainties regarding accounting estimates.

Note 4. Significant Events in the Reporting Period

Impact from COVID-19

The Company is closely monitoring the potential impact of COVID-19 on the 2021 financial results and cash flows and beyond. The Company’s top priority remains the health and safety of its staff and the patients in the studies. The Company maintains compliance with government and health authorities. Additionally, we have adapted the way in which we work to ensure we are doing our part in reducing transmission of COVID-19.

The Company has worked closely with laboratories and investigators to ensure safe continuation and working requirements of our ongoing research activities and human clinical trials. The Company has not experienced a materially negative impact from COVID-19. As of March 31, 2021, the impact of the COVID-19 pandemic continues to unfold. As events continue to evolve and additional information becomes available, our estimates may change materially in the future.

While business travel has been suspended, the Company has remained active and effective in the process of raising capital with institutional investors by conducting key meetings on a virtual basis.

Stock Split

On January 4, 2021, the Company effected the Stock Split resulting in a reduction of the nominal value of the Company’s ordinary shares from DKK 2 to DKK 1.

Initial Public Offering

On February 5, 2021, the Company completed its IPO. Refer to Note 1 for further details.

Note 5. Share-Based Payments

Warrant Program and Amendments

The Company’s Articles of Association allow for the granting of equity compensation, in the form of equity settled warrants, to employees, consultants and Scientific Advisory Board members who provide services similar to employees, members of executive management, and the board of directors. The warrants granted in 2018 or prior become exercisable upon an exit event, which triggers an immediate vesting, or at any time as determined by the board of directors in accordance with the terms of the plan. The warrants granted in 2020 vest either gradually over 36 months or vest immediately. Vested warrants granted in 2020 are exercisable in certain exercise windows beginning in the second half of the year of 2021. Warrants granted up until 2019 expire on December 31, 2036. Warrants granted in 2020 expire on December 31, 2031. For the three months ended March 31, 2021 and 2020, the number of warrants as a percentage of outstanding ordinary shares was 11.5% and 12.6%, respectively.

On January 4, 2021, the Company effected its Stock Split which also resulted in a reduction of the nominal value of the Company’s ordinary shares from DKK 2 to DKK 1. In accordance with the anti-dilution provisions of the warrant agreements, the number of warrants was increased by a ratio of 36 and the exercise price was decreased from DKK 2 to 1 DKK. Accordingly, information related to the Company’s warrants, have been retroactively adjusted to reflect the stock split and the bonus shares for all periods presented.

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Table of Contents

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

The following schedule specifies the granted warrants:

Weighted Average

Exercise

Number of

Price/Share

    

warrants

    

(DKK)

Warrants granted as at December 31, 2020

 

2,228,076

 

DKK 1

Warrants granted

 

– 

 

1

Warrants forfeited

 

(7,566)

 

1

Warrants cancelled

 

(10,404)

 

1

Warrants granted as at March 31, 2021

 

2,210,606

 

DKK 1

Warrants exercisable as at March 31, 2021

 

– 

 

Weighted Average

Exercise

Number of

Price/Share

    

warrants

    

(DKK)

Warrants granted as at December 31, 2019

 

1,932,156

 

DKK 1

Warrants granted

 

– 

 

1

Warrants forfeited

 

– 

 

1

Warrants cancelled

 

(22,032)

 

1

Warrants granted as at March 31, 2020

 

1,910,124

 

DKK 1

Warrants exercisable as at March 31, 2020

 

– 

 

In the interim period ended March 31, 2021, no warrants were granted. Employees will be entitled to receive a number of warrants based on the individual employee’s grade and performance for 2021. The warrants will be granted in December 2021 at the share price at grant date and will vest monthly over 36 months. For the three months ended March 31, 2021 and March 31, 2020, a service cost of $0.3 million and $0.7 million has been recognized respectively, based on the estimated fair value of the warrants expected to be granted.

Subsequent to the Company’s IPO, determining the initial fair value and subsequent accounting for equity awards require significant judgment regarding expected life and volatility of an equity award; however, as a public listed company there is objective evidence of the fair value of an ordinary share on the date an equity award is granted. On the other hand, due to the fact that as of 2021, warrants will be granted at the share price on the date of grant, fair value comprises a time value which is significantly affected by the expected life and expected volatility. The expected life of a warrant is based on the assumption that the holder will not exercise until after the equity award is fully vested. Actual exercise patterns may differ from the assumption used herein. The expected volatility is based on peer group data and reflects the assumption that the historical volatility over a period similar to the life of the warrant is indicative of future trends, which may not necessarily be the actual outcome. The peer group consists of listed companies that management believes are similar to the Company in respect to industry and stage of development. Even with objective evidence of the fair value of an ordinary share, small changes in any other individual assumption or in combination with other assumptions could have resulted in significantly different valuations.

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Table of Contents

Notes to the Unaudited Condensed Consolidated Interim Financial Statements

Note 6. Capital Structure and Financial Matters

Share Capital – Ordinary Shares

The following are changes in the Company’s share capital for the period ended March 31,2021:

Number of

Share Capital

Ordinary Shares

(DKK in thousands)

Share capital, December 31, 2020

    

16,198,668

    

16,198

Capital increase at February 9, 2021 for initial public offering

 

3,000,000

 

3,000

Share capital, March 31, 2021

 

19,198,668

 

19,198

Note 7. Events After the Reporting Period

No events have occurred as of the date of the authorization of the unaudited condensed consolidated interim financial statements.

10


Exhibit 99.2

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND

RESULTS OF OPERATIONS

You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, included with this report and the section contained in our Annual Report on Form 20-F for the year ended December 31, 2020 – “Item 5. Operating and Financial Review and Prospects”. The following discussion is based on our financial information prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union, might differ in material respects from generally accepted accounting principles in other jurisdictions.

Our financial information is presented in our presentation currency, United States Dollar, or USD. Our functional currency is the Danish Krone, or DKK. Some Danish Krone amounts in this discussion and analysis have been translated solely for convenience into U.S. dollar at an assumed exchange rate of DKK 6.3431 per $1.00, which was the official exchange rate of such currencies as of March 31, 2021 rounded to four decimal places.

Special Note Regarding Forward-Looking Statements

This interim report contains forward-looking statements concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Many of the forward-looking statements contained in this interim report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “should,” “target,” “would” and other similar expressions that are predictions of or indicate future events and future trends, although not all forward-looking statements contain these identifying words. These forward-looking statements include, but are not limited to, statements about:

the initiation, timing, progress, results, and cost of our research and development programs and our current and future pre-clinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs;
the timing of and our ability to obtain and maintain regulatory approval for our product candidates;
our ability to identify research opportunities and discover and develop investigational medicines;
the ability and willingness of our third-party collaborators to continue research and development activities relating to our development candidates and investigational medicines;
our expectations regarding the size of the patient populations for our product candidates, if approved for commercial use;
our estimates of our expenses, ongoing losses, future revenue and capital requirements and our needs for or ability to obtain additional financing;
our ability to identify, recruit and retain key personnel;
our and our collaborators’ ability to protect and enforce our intellectual property protection for our proprietary and collaborative product candidates, and the scope of such protection;

1


the development of and projections relating to our competitors or our industry;
our ability to commercialize our product candidates, if approved;
the pricing and reimbursement of our investigational medicines, if approved;
the rate and degree of market acceptance of our investigational medicines;
the amount of and our ability to use our net operating losses, or NOLs, and research and development credits to offset future taxable income;
our ability to manage our development and expansion;
regulatory developments in the United States and foreign countries;
adverse effects on our business condition and results for operation from the global COVID-19 pandemic, including the pace of global economic recovery from the pandemic;
our ability to manufacture our product candidates with advantages in turnaround times or manufacturing cost;
our ability to implement, maintain and improve effective internal controls;
our expectations regarding the time during which we will be an emerging growth company under the JOBS Act and a foreign private issuer; and
other risk factors.

These forward-looking statements are based on senior management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this report may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section in our Annual Report on Form 20-F for the year ended December 31, 2020 — “Item 3. Key Information—D. Risk Factors”. You are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Given these risks and uncertainties, you are cautioned not to rely on such forward-looking statements as predictions of future events.

You should read this report and the documents that we reference in this report and have filed as exhibits to this report completely and with the understanding that our actual future results may be materially different from what we expect. You should also review the factors and risks we describe in the reports we will file or submit from time to time with the Securities and Exchange Commission after the date of this report. We qualify all of our forward-looking statements by these cautionary statements.

Significant Risks and Uncertainties

As a biotech company, we face a number of risks and uncertainties. These are common for the industry and relate to operations, research and development, commercial and financial activities. For further information about risks and uncertainties the Company faces, we refer to our Form 20-F for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (SEC) on April 7, 2021. At the date of this interim report, there have been no significant changes to our overall risk profile since the publication of the Form 20-F.

2


Overview

We are a clinical-stage AI-immunology™ platform company using our proprietary artificial intelligence, or AI, technology, engineering expertise and drug development know-how to identify and develop novel immunotherapies and vaccines. To validate the predictive power and scalability of our AI technology platforms, we have identified and are developing a pipeline of clinical product candidates initially focused on the areas of immuno-oncology and infectious diseases. We currently have two product candidates in clinical development in oncology and we are advancing multiple preclinical candidates in oncology, bacterial diseases and viral infections. We are also working to apply our AI technology in additional therapeutic areas to address unmet medical needs.

PIONEER platform

PIONEER is our proprietary AI platform for the rapid discovery and design of patient-specific neoepitope-based cancer immunotherapies. We believe our proprietary in silico AI models within PIONEER allow us to efficiently identify and select those neoepitopes that we believe will generate a strong de novo T-cell response leading to significant antitumor effect in each patient. By combining these neoepitopes with a purposefully selected delivery modality believed to further enhance this antitumor effect, we design and deliver our immunotherapies to patients, with the goal of training their immune systems to target and kill cancer cells. We are currently advancing a unique pipeline of patient-specific cancer immunotherapies derived from our PIONEER platform, including EVX-01, EVX-02 and EVX-03.

EVX-01

Our first lead product candidate developed using our PIONEER platform, EVX-01, is a novel liposomal, peptide-based cancer immunotherapy designed to engage a patient’s own immune system to fight various cancers by mounting a neoepitope-specific immune response against tumors. EVX-01 is currently in a clinical Phase 1/2a trial in three indications: metastatic and/or unresectable melanoma, NSCLC and bladder cancer, administered in combination with current standard of care, PD-1/PD-L1 checkpoint inhibitor, or CPI. We believe that our therapeutic neoepitopes could change the treatment paradigm in combination with PD-1/PD-L1 CPIs across these three indications by expanding the patient population responding to PD-1/PD-L1 inhibitor treatment (CPI-resistant patients) and potentially increasing the antitumor effect in patients already responding to PD-1/PD-L1 inhibition treatment. The trial commenced in January 2019 and we anticipate a data readout from our Phase 1/2a trial by the end of the second quarter of 2021.

Early results indicate that the combination therapy is well-tolerated without any dose limiting toxicities reported for the low- and mid-dose levels. Three out of five patients treated with low-dose EVX-01 demonstrated clinical benefit, including one complete response and two partial responses. 100% of the five patients had reactive T cells and 80.5% of the administered neoepitopes induced reactive T cells in patients, of which 84.8% were de novo responses.

EVX-02

Our second lead product candidate developed using our PIONEER platform, EVX-02, is a novel, DNA-based cancer immunotherapy designed to induce a therapeutic immune response in the adjuvant setting in patients with resected melanoma. EVX-02 is currently in a clinical Phase 1/2a trial in resectable Stage III/IV melanoma patients, administered in combination with current standard of care, PD-1 CPI. We believe EVX-02 will induce a de novo neoepitope-specific T-cell response with antitumor effect, which will be amplified by the combination with PD-1 CPI. The trial commenced in July 2020 and we anticipate a data readout from our Phase 1/2a trial by the end of the second quarter of 2021.

EVX-03

Our third product candidate developed using our PIONEER platform, EVX-03, is an innovative, DNA-based neoepitope immunotherapy with an antigen presenting cell, or APC, targeting unit, intended for the treatment of multiple cancers. EVX-03 is in late pre-clinical development. Data from ongoing pre-clinical studies has shown high levels of neoepitope-reactive T cells as well as antitumor effect. We intend to submit a regulatory filing for initiation of our clinical trial in the second half of 2021.

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EDEN platform

EDEN is our second AI-driven platform that rapidly identifies novel, highly protective antigens for use in pathogen-specific prophylactic vaccines against bacteria, including drug-resistant bacteria. Within EDEN, our proprietary algorithms allow us to predict and identify those antigens that we believe will trigger a robust, protective immune response against almost any bacterial infectious disease. EDEN has also been constructed to optimize vaccine antigens, i.e. engineer such antigens into soluble vaccine constructs for large scale production, which we believe will allow us to move antigen candidates into the clinic far faster than traditional vaccine discovery approaches.

We believe our approach can be used to target almost any bacterial infection and rapidly enables the discovery and development of vaccine product candidates. We intend to use EDEN to develop a pipeline of vaccine product candidates for the prevention of bacterial diseases. We are currently focused on the development of EVX-B1, our novel vaccine product candidate for the prevention of S. aureus (including MRSA) infections.

EVX-B1

Our EVX-B1 product candidate, derived from our EDEN platform, is a multi-component subunit vaccine, initially being developed for the prevention of S. aureus induced SSTI in patients undergoing hernia surgery. EVX-B1 is currently in pre-clinical development We expect to file an Investigational New Drug, or IND, Application with the U.S. Food and Drug Administration, or FDA, in the second half of 2022. EVX-B1 combines highly protective antigens identified by EDEN in with our proprietary toxin fusion protein formulated together with a potent adjuvant, CAF01. We believe our EVX-B1 product candidate will be an effective vaccine as it targets multiple virulence factors and covers the diversity of different S. aureus strains.

RAVEN

We are developing our third proprietary AI platform, RAVEN, to bring our unique AI approach to vaccine design and development for viral diseases. RAVEN combines the essential AI models from our PIONEER platform with structural bioinformatic tools from EDEN to arrive at a novel, potent B- and T-cell vaccine design concept. We combine both elements seamlessly into a novel vaccine the effects of which we believe will be further enhanced by application of our proprietary APC targeting DNA delivery modality. We believe the combination of these technologies will allow for rapid development of new and innovative vaccines against viral diseases.

GRAPHIC

We are currently utilizing the novel coronavirus known as COVID-19 as a model to develop the RAVEN platform to be able to rapidly identify and develop prophylactic vaccines against any future, emergent coronavirus strains as well as other viral diseases.

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Results of Operations

Impact from COVID-19 Pandemic

The COVID-19 pandemic has resulted in a widespread health crisis and numerous disease control measures being taken to limit its spread. Governments have instituted quarantining and mandated business and school closures. Travel has been severely restricted. On a macroeconomic level, many experts predict that the outbreak will trigger a period of global economic slowdown or a global recession.

The full extent to which the COVID-19 outbreak will impact our business, results of operations, financial condition and cash flows will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19 and the actions to contain it or treat its impact and the economic impact on local, regional, national and international markets. As the COVID-19 pandemic continues, our results of operations, financial condition, and cash flows may be adversely affected, particularly if the pandemic persists for an extended period of time.

As of the reporting date, we have not identified significant COVID-19 related disruptions to our business, including clinical trial operations, or identified any of our third-party manufacturers not being able to meet their obligations. In addition, no significant transactions, as a result of COVID-19, have been recognized during the first three months of 2021.

To minimize the risk of spread of COVID-19, we have taken precautionary measures within our organization, including encouraging our employees to work remotely, reducing travel activity, and minimizing face-to-face meetings. To accommodate efficient procedures for financial reporting, including internal controls, we have, also before the pandemic, structured our work environment to enable our employees to perform their tasks remotely. Accordingly, it has not been necessary to make material changes to our internal control over financial reporting due to the pandemic. In addition, we monitor and have a close dialogue with third-party manufacturing suppliers, in order to mitigate the risk from disruptions in the supply chain that may result from COVID-19.

However, while the global outbreak of COVID-19 continues to impact global societies, the extent to which COVID-19 impacts our business will depend on the future development, which is highly uncertain and cannot be reliably predicted. While COVID-19 continues to impact the world in several aspects, the development is monitored closely by our management, including any impact this may have on our financial performance and financial position. Our top priority remains the health and safety of our staff and the patients in our studies.

Comparison of the three months ended March 31, 2021 and 2020:

    

Three Months Ended March 31,

 

    

2021

    

2020

    

Change

(USD in thousands)

Operating expenses:

Research and development

$

3,893

$

2,510

$

1,383

General and administrative

1,282

781

501

Total operating expenses

5,175

3,291

1,884

Operating loss

(5,175)

(3,291)

(1,884)

Finance income

972

16

956

Finance expenses

(297)

(4)

(293)

Net loss before tax

(4,500)

(3,279)

(1,221)

Income taxes

407

180

227

Net loss for the period

$

(4,093)

$

(3,099)

$

(994)

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Research and Development

Research and development expenses were $3.9 million for the three months ended March 31, 2021 as compared to $2.5 million for the three months ended March 31, 2020. The increase in research and development expenses was primarily due to increased spending of $1.0 million for ongoing development utilizing our AI platforms, pre-clinical product candidates, and clinical trials. In addition, employee-related costs increased by $0.4 million due to higher headcount.

General and Administrative

General and administrative expenses were $1.3 million for the three months ended March 31, 2021 as compared to $0.8 million for the three months ended March 31, 2020. The increase in general and administrative expenses was primarily due to a $0.5 million increase in overhead and professional fees related to the expansion of our corporate function for our initial public offering completed in February 2021.

Finance Income

Finance income was primarily related to foreign exchange gains on the receipts of our IPO proceeds, which were in USD while the functional currency is DKK, recognized during the three months ended March 31, 2021.

Finance Expenses

Finance expenses were primarily related to foreign exchange losses recognized during the three months ended March 31, 2021.

Income Taxes

The benefit from income tax was $0.4 million for the three months ended March 31, 2021 compared to $0.2 million for the three months ended March 31, 2020. Our effective tax rates for the three months ended March 31, 2021 and 2020 were different from the Danish effective statutory tax rate of 22% since we do not meet the requirement for capitalization of deferred tax assets. In connection with our initial public offering, we incurred non-deductible expenses which resulted in differences in our effective tax rates.

Liquidity and Capital Resources

Overview

We are a clinical development stage AI-immunology company that has not generated revenues during the reporting periods. We are exposed to a variety of financial risks including liquidity risks. We have incurred significant losses and negative cash flows from operations since our inception. As of March 31, 2021, we had an accumulated deficit of $31.1 million and expect to continue to incur significant losses for the foreseeable future.

As of March 31, 2021 and December 31, 2020, our available liquidity, comprised of cash and cash equivalents, was $27.0 million and $5.8 million, respectively and our total equity was $27.8 million and $7.0 million, respectively. The increase in cash and equity was primarily a result of the proceeds received from the completion of our initial public offering, discussed below. We have not generated any revenues during the three months ended March 31, 2021 and 2020 and we do not anticipate generating revenues unless and until we successfully complete Phase 2b development and obtain an out-licensing partnership of any current or future product candidates.

In August 2020, we executed a loan agreement, or the EIB Loan Agreement, with the European Investment Bank, or EIB, for a principal amount of €20.0 million, divided into 3 tranches of €7.0 million, €6.0 million and €7.0 million or the EIB Loan. Under the EIB Loan Agreement, the EIB Loan tranche balances are due six years from their respective disbursement dates. For each tranche drawn down, EIB is entitled to an aggregate of 1,003,032 cash settled warrants with an exercise price of 1 DKK per warrant. The 351,036 warrants attributable to the first tranche of €7.0 million were incorporated in the

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articles of association on December 17, 2020. As of March 31, 2021, and as of the date of this report, we had not drawn down on the EIB Loan Agreement.

In September 2020, we received $6.6 million of additional funding from the issuance of 745,380 of our ordinary shares as part 1 of our “bridging round” with outside investors. On October 15, 2020, we successfully completed part 2 of our “bridging round” of capital with outside investors in the amount of $2.4 million from the issuance of 269,136 of our ordinary shares and received the proceeds in November 2020.

In October 2020, the Company entered into a lease for approximately 1,356 square meters, which is allocated on 839 square meters of office space, and 518 square meters of laboratory space in Hoersholm, Denmark. The commencement date for the lease was February 1, 2021 and the lease continues for a term of 10 years from that date. The lease agreement contains an early termination provision which would trigger a termination fee of $2.7 million. The initial monthly payment is $28,800, which consist of $12,000 for the office space, and $16,800 for the laboratory space. Through-out the term, the lease is subject to increases ranging from 2-4% on the annual lease payment amount.

On February 5, 2021, we completed our initial public offering through which we issued and sold 3,000,000 ADSs, each of which represents one ordinary share, at a price to the public of $10.00 per ADS. We received aggregate net proceeds of $25.3 million from the initial public offering, after deducting the underwriting discounts and commissions and offering expenses. Upon the completion of the initial public offering, our registered, issued, and outstanding share capital was nominal DKK 19,198,668 divided into 19,198,668 ordinary shares of DKK 1 each.

Financing Requirements

We anticipate incurring additional losses until such time, if ever, we can complete our research and development activities and obtain an out-licensing partnership for our product candidates and generate revenues from such product candidates. Substantial additional financing will be needed by us to fund our operations and to continue development of our product candidates.

Based on our current operating plan, our board of directors believe that the existing cash and cash equivalents, including the net proceeds from our initial public offering completed on February 5, 2021 and funding arrangements with current investors and EIB, along with management initiatives, will provide us with necessary resources to support our operations for at least 12 months from March 31, 2021. However, the forecast of the period of time through which our financial resources will be adequate to support operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could use capital resources sooner than expected. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses is uncertain.

Future financing requirements will depend on many factors, including, but not limited to:

the scope, progress, results and costs of researching and developing our AI platforms;
the timing of, and the costs involved in providing support to our future partners, if any, in connection with their efforts in seeking regulatory approvals in the United States and elsewhere for any future products derived from our product candidates if clinical trials are successful;
the cost of providing support to our future partners, if any, in connection with their commercialization activities for products derived from our product candidates, if approved for sale, including marketing, sales and distribution costs;
the cost of manufacturing any future product candidates for clinical trials and scaling up manufacturing in preparation for late stage clinical trials;
the number and characteristics of additional product candidates that we pursue;

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our ability to establish and maintain collaboration, partnerships, licensing or other arrangements with third parties, including the timing of receipt of any potential milestone payments, licensing fees or royalty payments under these agreements;
the impact of the COVID-19 pandemic on the initiation or completion of pre-clinical studies or clinical trials and the supply of our product candidates;
our ability to maintain, expand, and defend the scope of our intellectual property portfolio, including the amount and timing of any payments we may be required to make in connection with the licensing, filing, defense, and enforcement of any patents or other intellectual property rights;
the timing, receipt, and amount of sales of, or royalties on, any products developed by our future partners, if any, derived from our product candidates;
our need and ability to hire additional management, scientific, technical and business personnel; and
the extent to which we acquire or invest in businesses, products, or technologies (although we currently have no commitments or agreements relating to any of these types of transactions).

We expect to finance cash needs through equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements.

We may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of current shareholders could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of the current shareholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise funds through collaborations, licenses and other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable and/or may reduce the value of our ordinary shares. Failure to raise capital or enter into such other arrangements when needed could have a negative impact on financial conditions and our ability to pursue our business plans and strategies. If we are unable to raise additional capital when needed, we could be forced to delay, limit, reduce or terminate product candidate development or grant rights to develop and market product candidates.

Cash Flows

The following table summarizes our cash flows for the periods indicated (unaudited):

    

Three Months Ended March 31,

 

2021

    

2020

(USD in thousands)

Cash Flow Data:

Net cash used in operating activities

$

(4,035)

$

(2,950)

Net cash used in investing activities

(327)

(81)

Net cash provided by/(used in) financing activities

25,252

(18)

Net increase/(decrease) in cash and cash equivalents

$

20,890

$

(3,049)

Operating Activities

Net cash used in operating activities was $4.0 million for the three months ended March 31, 2021. The largest component of our cash used in operating activities during this period was a net loss for the period of $4.0 million and non-cash adjustments of $1.0 million offset by a net cash change in our working capital during the period of $1.0 million. The non-

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cash adjustments primarily consisted of foreign exchange rate adjustments and various other immaterial changes of $0.8 million, a change in income tax benefit of $0.4 million, and a change in tax credit schemes accounted for as grants of $0.1 million. The non-cash adjustments were offset by a change in share-based compensation expense of $0.3 million. The positive net cash attributable to changes in our current operating assets (excluding cash) and our current operating liabilities during the period was primarily comprised of an increase of $0.9 million in trade payables and an increase of $0.2 million in other payables, both due to the timing of invoices received, offset by a $0.1 million increase of receivables due to timing of prepayments in our research and development activities.

Net cash used in operating activities was $3.0 million for the three months ended March 31, 2020. The largest component of our cash used in operating activities during this period was a net loss for the period of $3.1 million offset by non-cash charges of $0.5 million and increased by net cash change in our working capital during the period of $0.4 million. The non-cash charges primarily consisted of share-based compensation expense of $0.7 million offset by a change in income tax benefit of $0.2 million. The negative net cash attributable to changes in our current operating assets (excluding cash) and our current operating liabilities during the period was primarily comprised of an increase of $0.1 million in trade payables, offset by a decrease of $0.2 million in other payables, both due to the timing of invoices received, and a $0.3 million increase of receivables due to timing of prepayments in our research and development activities.

Investing Activities

Net cash used in investing activities was primarily driven by the purchase of property, plant and equipment in the amounts of $282,000 and changes in leasehold deposits of $15,000, for the three months ended March 31, 2021. Net cash used in investing activities for the purchase of intangible assets was $60,000 for the three months ended March 31, 2021.

Net cash used in investing activities was primarily driven by the purchase of property, plant and equipment in the amounts of $64,000 and changes in leasehold deposits of $17,000, for the three months ended March 31, 2020.

Financing Activities

Net cash provided by financing activities was $25.3 million for the three months ended March 31, 2021, which was primarily due to net proceeds from the issuance of shares of $27.9 million from our IPO, partially offset by transaction costs of $2.6 million related to the issuance of shares.

Net cash used in financing activities for the three months ended March 31, 2020 was immaterial.

Off-balance Sheet Arrangements

As of March 31, 2021, we did not have any material off-balance sheet arrangements that have, or are reasonably likely to have, a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources. We did not have any other off-balance sheet arrangements, as defined in the rules and regulations of the SEC, as of or during the periods presented.

Quantitative and Qualitative Disclosures About Market Risk

Market risk is the risk that the fair value of, or future cash flows from, a financial instrument will vary due to changes in market prices. The type of market risk that primarily impacts us is foreign currency risk.

Foreign Currency Risk

Foreign currency risk is the risk that the fair value or future cash flows of an exposure will fluctuate because of changes in foreign exchange rates. The primary exposure derives from our expenditures in foreign currencies, mainly the USD, the Australian Dollar and the British Pound. This exposure is known as transaction exposure. We are exposed to foreign currency risk as a result of operating transactions and the translation of foreign currency bank accounts and short-term deposits. We seek to minimize our exchange rate risk by maintaining cash positions in the currencies in which we expect to incur the majority of our future expenses and we make payments from those positions.

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Interest Rate Risk

We manage interest rate risk by monitoring short- and medium-term interest rates and placing cash on deposit for periods that optimize the amount of interest earned while maintaining access to sufficient funds to meet day-to-day cash requirements. We do not currently have any loans or holdings that have variable interest rate. Accordingly, we are not exposed to material interest rate risk.

Recently Adopted Accounting Pronouncements and Accounting Pronouncements Not Yet Adopted

A description of recently adopted accounting pronouncements and accounting pronouncements not yet adopted that may potentially impact our financial position and results of operations is disclosed in Note 2 to our audited consolidated financial statements in our Annual Report on Form 20-F for the year ended December 31, 2020.

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