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 August 2025
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 ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 of 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) and on Form F-1 (File No. 333-266050), 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of such registration statements and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Furnished as Exhibits to this Report on Form 6-K is information regarding the Company’s financial results for the fiscal quarter ended June 30, 2025.
Exhibits
| Exhibit |
||
| No. |
Description |
|
| Unaudited Condensed Consolidated Interim Financial Statements. |
||
| Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
||
| 101.INS |
Inline XBRL Instance Document |
|
| 101.SCH |
Inline XBRL Taxonomy Extension Schema |
|
| 101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase |
|
| 101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase |
|
| 101.LAB |
Inline XBRL Taxonomy Extension Label Linkbase |
|
| 101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase |
|
| 104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
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.
| Evaxion Biotech A/S |
||
| Date: August 13, 2025 |
By: |
/s/ Birgitte Rønø |
| Birgitte Rønø |
||
| Chief Executive Officer |
||
| Date: August 13, 2025 |
By: |
/s/ Thomas Frederik Schmidt |
| Thomas Frederik Schmidt |
||
| Chief Financial Officer |
Exhibit 99.1
EVAXION BIOTECH A/S
INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
| Page |
|
| Notes to Unaudited Condensed Consolidated Interim Financial Statements |
EVAXION BIOTECH A/S
Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss
| Three Months Ended June 30, |
Six Months Ended June 30, |
|||||||||||||||||||
| 2025 |
2024 |
2025 |
2024 |
|||||||||||||||||
|
|
Note | (USD in thousands, except per share amounts) |
||||||||||||||||||
| Revenue |
5 | $ | 37 | $ | 154 | $ | 37 | $ | 205 | |||||||||||
| Research and development |
(2,165 | ) | (2,752 | ) | (4,321 | ) | (5,588 | ) | ||||||||||||
| General and administrative |
(2,212 | ) | (1,983 | ) | (3,924 | ) | (3,594 | ) | ||||||||||||
| Operating loss |
(4,340 | ) | (4,581 | ) | (8,208 | ) | (8,977 | ) | ||||||||||||
| Finance income |
9 | 546 | 220 | 3,039 | 5,838 | |||||||||||||||
| Finance expenses |
9 | (1,232 | ) | (2,036 | ) | (1,629 | ) | (2,282 | ) | |||||||||||
| Net loss before tax |
(5,026 | ) | (6,397 | ) | (6,798 | ) | (5,421 | ) | ||||||||||||
| Income tax benefit |
195 | 199 | 387 | 417 | ||||||||||||||||
| Net loss for the period |
$ | (4,831 | ) | $ | (6,198 | ) | $ | (6,411 | ) | $ | (5,004 | ) | ||||||||
| Net loss attributable to shareholders of Evaxion Biotech A/S |
$ | (4,831 | ) | $ | (6,198 | ) | $ | (6,411 | ) | $ | (5,004 | ) | ||||||||
| Other comprehensive income that may be reclassified to profit or loss in subsequent periods: |
||||||||||||||||||||
| Exchange differences on translation of foreign operations |
(45 | ) | 24 | (78 | ) | 9 | ||||||||||||||
| Other comprehensive income that will not be reclassified to profit or loss in subsequent periods: |
||||||||||||||||||||
| Exchange differences on currency translation to presentation currency |
714 | 4 | 597 | 101 | ||||||||||||||||
| Other comprehensive income for the period, net of tax |
$ | 669 | $ | 28 | $ | 519 | $ | 110 | ||||||||||||
| Total comprehensive loss |
$ | (4,162 | ) | $ | (6,170 | ) | $ | (5,892 | ) | $ | (4,894 | ) | ||||||||
| Total comprehensive loss attributable to shareholders of Evaxion Biotech A/S |
$ | (4,162 | ) | $ | (6,170 | ) | $ | (5,892 | ) | $ | (4,894 | ) | ||||||||
| Loss per share – basic and diluted |
$ | (0.02 | ) | $ | (0.12 | ) | $ | (0.03 | ) | $ | (0.10 | ) | ||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
EVAXION BIOTECH A/S
Unaudited Condensed Consolidated Interim Statements of Financial Position
| June 30, 2025 |
December 31, 2024 |
|||||||||||
| (USD in thousands) |
||||||||||||
| ASSETS |
|
Note | ||||||||||
| Non-current assets |
||||||||||||
| Property and equipment, net |
$ | 3,623 | $ | 3,514 | ||||||||
| Government grants receivable |
40 | 44 | ||||||||||
| Tax receivables, non-current |
424 | — | ||||||||||
| Leasehold deposits, non-current |
185 | 162 | ||||||||||
| Total non-current assets |
4,272 | 3,720 | ||||||||||
| Current assets |
||||||||||||
| Prepayments and other receivables |
2,567 | 1,273 | ||||||||||
| Tax receivables, current |
864 | 1,540 | ||||||||||
| Cash and cash equivalents |
14,746 | 5,952 | ||||||||||
| Total current assets |
18,177 | 8,765 | ||||||||||
| TOTAL ASSETS |
$ | 22,449 | $ | 12,485 | ||||||||
| EQUITY (DEFICIT) AND LIABILITIES |
||||||||||||
| Share capital |
10 | $ | 11,823 | $ | 10,516 | |||||||
| Other reserves |
119,351 | 106,369 | ||||||||||
| Accumulated deficit |
(124,948 | ) | (118,537 | ) | ||||||||
| Total equity (deficit) |
6,226 | (1,652 | ) | |||||||||
| Non-current liabilities |
||||||||||||
| Lease liabilities, non-current |
1,712 | 1,620 | ||||||||||
| Borrowings, non-current |
7 | 9,031 | 8,008 | |||||||||
| Provisions |
158 | 141 | ||||||||||
| Total non-current liabilities |
10,901 | 9,769 | ||||||||||
| Current liabilities |
||||||||||||
| Lease liabilities, current |
356 | 314 | ||||||||||
| Derivative liability |
6 | 1,131 | — | |||||||||
| Borrowings, current |
7 | 184 | 159 | |||||||||
| Trade payables |
2,496 | 2,968 | ||||||||||
| Other payables |
1,155 | 927 | ||||||||||
| Total current liabilities |
5,322 | 4,368 | ||||||||||
| Total liabilities |
16,223 | 14,137 | ||||||||||
| TOTAL EQUITY AND LIABILITIES |
$ | 22,449 | $ | 12,485 | ||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
EVAXION BIOTECH A/S
Unaudited Condensed Consolidated Interim Statements of Changes in Equity (Deficit)
| Other reserves |
||||||||||||||||||||||||||||
|
|
Note | Share capital |
Share premium |
Share-based payments reserve |
Foreign currency translation reserve |
Accumulated deficit |
Total equity (deficit) |
|||||||||||||||||||||
| (USD in thousands) |
||||||||||||||||||||||||||||
| Equity at December 31, 2024 |
$ | 10,516 | $ | 95,942 | $ | 14,022 | $ | (3,595 | ) | $ | (118,535 | ) | $ | (1,652 | ) | |||||||||||||
| Net loss for the period |
— | — | — | — | (6,411 | ) | (6,411 | ) | ||||||||||||||||||||
| Other comprehensive income |
— | — | — | 519 | — | 519 | ||||||||||||||||||||||
| Share-based compensation |
8 | — | — | 131 | — | — | 131 | |||||||||||||||||||||
| Issuance of shares for cash |
10 | 1,307 | 16,521 | — | — | — | 17,828 | |||||||||||||||||||||
| Non-cash effect from issue of investor warrants classified as derivative liability |
6 | — | (2,432 | ) | — | — | — | (2,432 | ) | |||||||||||||||||||
| Transaction costs |
— | (1,757 | ) | — | — | — | (1,757 | ) | ||||||||||||||||||||
| Forfeited warrants |
— | 207 | (207 | ) | — | — | — | |||||||||||||||||||||
| Revaluation SBC reserve |
— | 4,145 | (4,145 | ) | — | — | — | |||||||||||||||||||||
| Equity at June 30, 2025 |
$ | 11,823 | $ | 112,626 | $ | 9,801 | $ | (3,076 | ) | $ | (124,948 | ) | $ | 6,226 | ||||||||||||||
| Other reserves |
||||||||||||||||||||||||||||
|
|
Note | Share capital |
Share premium |
Share-based payments reserve |
Foreign currency translation reserve |
Accumulated deficit |
Total equity (deficit) |
|||||||||||||||||||||
| (USD in thousands) |
||||||||||||||||||||||||||||
| Equity at December 31, 2023 |
$ | 5,899 | $ | 87,450 | $ | 13,665 | $ | (3,773 | ) | $ | (107,970 | ) | $ | (4,729 | ) | |||||||||||||
| Net loss for the period |
— | — | — | — | (5,004 | ) | (5,004 | ) | ||||||||||||||||||||
| Other comprehensive income |
— | — | — | 110 | — | 110 | ||||||||||||||||||||||
| Share-based compensation |
8 | — | — | 101 | — | — | 101 | |||||||||||||||||||||
| Issuance of shares for cash |
10 | 2,345 | 11,837 | — | — | — | 14,182 | |||||||||||||||||||||
| Non-cash effect from issue of investor warrants classified as derivative liability |
6 | — | (1,097 | ) | — | — | — | (1,097 | ) | |||||||||||||||||||
| Transaction costs |
— | (2,310 | ) | — | — | — | (2,310 | ) | ||||||||||||||||||||
| Equity at June 30, 2024 |
$ | 8,244 | $ | 95,880 | $ | 13,766 | $ | (3,663 | ) | $ | (112,974 | ) | $ | 1,253 | ||||||||||||||
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
EVAXION BIOTECH A/S
Unaudited Condensed Consolidated Interim Statements of Cash Flows
| Six Months Ended |
||||||||
| June 30, |
||||||||
| 2025 |
2024 |
|||||||
| (USD in thousands) |
||||||||
| Operating activities: |
||||||||
| Net loss for the period |
$ | (6,411 | ) | $ | (5,004 | ) | ||
| Adjustments for non-cash items |
(1,599 | ) | (3,427 | ) | ||||
| Interest received |
109 | 95 | ||||||
| Interest paid |
(25 | ) | (29 | ) | ||||
| Income taxes (paid)/received |
776 | — | ||||||
| Cash flow from operating activities before changes in working capital |
(7,150 | ) | (8,365 | ) | ||||
| Cash flow from changes in working capital: |
||||||||
| Changes in net working capital |
(574 | ) | (620 | ) | ||||
| Net cash used in operating activities |
(7,724 | ) | (8,985 | ) | ||||
| Investing activities: |
||||||||
| Payment of non-current financial assets – leasehold deposits |
(3 | ) | (3 | ) | ||||
| Net cash used in investing activities |
(3 | ) | (3 | ) | ||||
| Financing activities: |
||||||||
| Proceeds from issuance of shares and exercise of warrants |
17,828 | 14,182 | ||||||
| Transaction costs related to issuance of shares |
(1,757 | ) | (2,310 | ) | ||||
| Repayment of borrowings |
(308 | ) | (313 | ) | ||||
| Leasing installments |
(170 | ) | (165 | ) | ||||
| Net cash provided by/ (used in) financing activities |
15,593 | 11,394 | ||||||
| Net increase/ (decrease) in cash and cash equivalents |
7,866 | 2,406 | ||||||
| Cash and cash equivalents at January 1 |
5,952 | 5,583 | ||||||
| Exchange rate adjustments on cash and cash equivalents |
928 | 4 | ||||||
| Cash and cash equivalents at June 30 |
$ | 14,746 | $ | 7,993 | ||||
The accompanying notes are an integral part of these unaudited condensed consolidated interim financial statements.
Note 1. General Company Information
Evaxion Biotech A/S is a pioneering clinical stage TechBio company based upon its the Artificial Intelligence (AI) platform: AI-Immunology™. The AI-Immunology™ platform consists of multiple proprietary and scalable AI prediction models harnessing the power of data, machine learning and artificial intelligence to decode the human immune system. This enables the development of novel vaccines for treatment of various cancers as well as, bacterial and viral infections. We believe we are the first in the world to demonstrate a link between predictive power of Artificial Intelligence, or AI, and clinical response in patients as evidenced by a clear association between AI-Immunology™ predictions and progression free survival in metastatic melanoma cancer patients. AI-Immunology™ allows for fast and effective discovery, design and development of novel vaccines and offers a strong value proposition towards existing and potential pharma partners. The value proposition is supported by AI-Immunology™ as the AI platform is being preclinically and clinically validated, adaptable, scalable to other disease areas and, we believe, reduces development cost and risks significantly. Partnerships are a key element in our approach to realizing value of the opportunities AI-Immunology™ caters for. Further, we have developed a clinical-stage oncology cancer pipeline of novel personalized therapeutic vaccines and a pre-clinical prophylactic vaccine pipeline for bacterial and viral diseases with high unmet medical needs based on AI-Immunology™ identified vaccine targets. Evaxion is committed to transforming patients’ lives by providing innovative and targeted treatment options through AI-Immunology™. Our purpose is saving and improving lives with AI-Immunology™. Unless the context otherwise requires, references to the “Company,” “Evaxion,” “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 Hørsholm, Denmark.
The unaudited condensed consolidated interim financial statements of Evaxion Biotech A/S and its subsidiaries (collectively, the “Group”) for the three and six months ended June 30, 2025 and 2024, were approved, and authorized for issuance, by the Board of Directors on August 13, 2025.
Note 2. Liquidity and Going Concern Assessment
Management and the Board of Directors has assessed the Company’s ability to continue as a going concern and believes the Company has adequate resources to meet its obligations in the foreseeable future. Following a successful public offering and at-the-market offering in January 2025 securing proceeds of $10.8 and $5.0 million respectively, with the Company’s current financial position, available funding, and projected cash flows, Management and the Board of Directors is confident that the Company will continue its operations for at least the next 12 months, and with our current strategic plans and forecasted cash burn, we have sufficient cash to finance operations into mid-2026.
Accordingly, the condensed consolidated interim financial statements has been prepared on a going concern basis in accordance with applicable accounting standards.
We have considered potential risks and uncertainties, including market conditions, economic factors, and liquidity needs. After reviewing the Company’s financial forecast and access to capital, the Board does not anticipate material uncertainties that would cast significant doubt on the Company’s ability to continue as a going concern.
On October 3, 2022, we entered into a Capital on Demand™ Sales Agreement, or the Sales Agreement, with JonesTrading Institutional Services LLC, or JonesTrading, pursuant to which we may sell from time to time, at our option, ADSs representing ordinary shares through or to JonesTrading, as sales agent or principal.
The ADSs are offered pursuant to a prospectus supplement, dated March 26, 2025, or the Prospectus Supplement, which was filed with the SEC on such date and our Form F-3 (Registration No. 333- 285778) shelf registration statement filed with the SEC on March 13, 2025 (the “2025 F-3”), and declared effective by the SEC on March 24, 2025. Pursuant to the Prospectus Supplement, we may offer and sell up to an aggregate of $ 4,480,000 of ADSs. Sales of the ADSs made pursuant to the Sales Agreement, are made by any method deemed to be an “at the market offering”, or ATM, as defined in Rule 415(a)(4) promulgated under the Securities Act. JonesTrading is not required to sell any specific number or dollar amount of ADSs but has agreed to use its commercially reasonable efforts to sell the ADSs from time to time, based upon our instructions, including any price, time or size limits or other customary parameters or conditions we may impose. The 2025 F-3 replaced the Form F-3 that had previously been filed on May 20, 2022, on Form F-3 (File No. 333-265132), which registration statement was declared effective on June 2, 2022 (the “2022 F-3”). Under the 2022 F-3, we were initially entitled to, from time to time, sell up to $100.0 million in the aggregate of ordinary shares and ordinary shares represented by ADSs. The 2022 F-3 was set to expire on June 2, 2025 and has been replaced by the 2025 F-3. As of January 24, 2025, we have sold a total of 837,027 ADSs under this ATM program for an aggregate purchase price of $14,413,306.
July 31, 2023, we entered into a financing agreement with Global Growth Holding Limited (“GGH”), for the issuance of convertible notes into our ordinary shares represented by ADSs, DKK 0.25 nominal value, with each ordinary share represented by one ADSs. Pursuant to the agreement, we may elect to sell GGH up to $20.0 million in such notes on any business day over the 36-month term of the agreement. We have under certain circumstances the right, but not the obligation, to direct GGH to purchase traches of up to $0.7 million, subject to certain limitations and conditions set forth in the agreement. In connection with the agreement, we are obligated to pay GGH a commitment fee totaling $1.1 million. At any time, GGH may, in its sole discretion, convert the notes into ordinary shares at specified conversion prices upon submission of a request for conversion by GGH to us. The financing agreement between us and GGH is subject to approval by the SEC through the date of this prospectus.
January 17, 2025, an extraordinary general meeting of Evaxion was held, where it was approved to reduce our share capital by nominal DKK 58,980,417 from nominal DKK 78,640,556 to nominal DKK 19,660,139 to cover loss. Furthermore, it was approved to reduce the nominal value of the shares from nominal DKK 1 per share to nominal DKK 0.25 per share, and our Article of Association were amended accordingly.
January 24, 2025, the Company sold 696,400 ADSs at an average price of USD $7.1776 per ADS. The ADSs were sold in an at-the-market (ATM) offering pursuant to the terms and subject to the conditions contained in that certain Capital Demand Sales Agreement between the Company and Jones Trading Institutional Services LLC dated October 3, 2022. After deducting fees and expenses, total proceeds to the Company from the sales of the ADSs were approximately $4.8 million.
January 31, 2025, the Company closed its public offering of an aggregate of 3,997,361 of its ADSs and warrants to purchase up to 50% of the ADSs offered at a combined public offering price of $2.71 per ADS with one accompanying warrant for each two ADSs, with gross proceeds of $10.8 million. The Company registered aggregate share capital increases of nominal DKK 49,967,012.50 with the Danish Business Authority, with effective date of January 31, 2025, corresponding to an aggregate increase in the Company’s share capital to nominal DKK 78,332,151.50. This reflected issuances of 199,868,050 shares in connection with the public offering.
Sales of ADSs or our ordinary shares as restrictions end or pursuant to the above-described agreements or pursuant to registration rights may make it more difficult for us to finance our operations through the sale of equity securities in the future at a time and at a price that we deem appropriate. These sales also could cause the trading price of the ADSs to fall and make it more difficult for holders of ADSs to sell the ADSs.
Note 3. 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 IFRS Accounting 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, 2024, and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board.
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 4.
The accounting policies applied are consistent with the accounting policies as outlined in the basis of presentation section included in Note 3 of the audited financial statements as of and for the year ended December 31, 2024.
New and Amended Standards and Interpretations
On January 1, 2025, the Company adopted the amendments to IAS 21, issued by the International Accounting Standards Board (“IASB”), regarding "Lack of Exchangeability." These amendments provide guidance on how to determine the exchange rate to be used in reporting foreign currency transactions when there is a lack of exchangeability between two currencies. The amendments aim to enhance the clarity and consistency of financial reporting where exchangeability is limited or nonexistent.
The adoption of these amendments did not have any impact on the Company's financial statements for the reporting period ending June 30, 2025. The Company has not encountered situations where the amendments would change its previous or current accounting judgments related to foreign currency transactions and translations. There are no other new IFRS or IFRS Interpretation Committee (“IFRIC”) interpretations effective during the six months ended June 30, 2025, that have a material impact to the interim condensed consolidated financial statements.
Standards issued but not effective
There were a number of standards and interpretations which were issued but were not yet effective on June 30, 2025, and have not been adopted for these unaudited condensed consolidated financial statements, including:
| ● |
Amendments to IFRS 9 & IFRS 7 Classification and Measurement of Financial Instruments ( January 1, 2026) |
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 4. Significant Accounting Judgements, Estimates, and Assumptions
In the application of its 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, 2024.
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 financial statements relate to going concern, liability-classified warrants and share-based compensation. See Note 2 above and Notes 6 and 8 below for additional information regarding liability classified warrants and share-based compensation, respectively.
There have been no other changes to the application of critical accounting judgments, or estimation uncertainties regarding accounting estimates.
Note 5. Revenue
In September 2023, the Company entered into a collaborative research agreement with MSD (tradename of Merck & Co., Inc., Rahway, NJ, USA (“MSD”), to explore new ways to apply AI technologies to vaccine discovery development. During the three and six months ended June 30, 2025 and 2024, the Company recognized services revenue of a nominal amount and $0.1 million from its research and development services, respectively.
In June 2025, the Gates Foundation awarded the Company a grant for $0.1 million to help the world eradicate polio (poliomyelitis) by exploring design options for a new and unique vaccine. The project will combine Evaxion’s leading and clinically validated AI-Immunology™ platform with support from the Gates Foundation. Evaxion will deploy AI-Immunology™ to identify and combine various antigens to combat the virus. Based on these findings, a number of new antigen constructs will be designed for selection and validation. During the three and six months ended June 30, 2025, the Company recognized a nominal amount of grant revenue related to the Gates Foundation Grant. The Company is expected to recognize the remainder of the grant revenue from the Gates Foundation Grant through August 2025.
During the three and six months ended June 30, 2025, all revenue earned was generated in Denmark from the Company’s collaborative research agreement with MSD and grant revenue from the Gates Foundation Grant.
Note 6. Financial Instruments and Risk Management
Financial risk management and risk management framework
In terms of financial risks, the Company has exposure to liquidity risk and market risk comprising foreign exchange risk. This note presents information about the Company’s exposure to each of the above risks together with the Company’s objectives, policies and processes for measuring and managing risks. The Company’s Board of Directors monitors each of these risks on a regular basis and implements policies as and when they are required. Details of the current risk management policies are provided below.
Liquidity risk
As of the date of the condensed consolidated interim financial statements the Company, and based on the Company’s current financial position, available funding, and projected cash flows, Management and the Board is confident that the Company will have sufficient funds available to finance operations into mid-2026. Additionally, refer to Note 2 for further discussion of the Company’s liquidity.
Market risk
Market risk is the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices. The type of market risk that impacts the Company is currency risk. The Company does not currently have any loans or holdings that have a variable interest rate. Accordingly, the Company is not exposed to material interest rate 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 the Company’s operating expenses paid in foreign currencies, mainly USD. This exposure is known as transaction exposure. Any reasonable or likely movements in foreign exchange rates would not have a material impact on the Company’s operating results. The Company’s policy for managing foreign currency risks is to convert cash received from financing activities to currencies consistent with the Company’s expected cash outflows.
Credit risk
Credit risk is the risk that a counterparty will not meet its obligations under a financial instrument, leading to a financial loss for the Company. The Company’s exposure to credit risk is limited to deposits with banks with high credit ratings. Accordingly, the Company does not have material credit risk and no provision for credit risk is recognized.
Capital management
The Company’s objectives when managing capital are to safeguard the Company’s ability to continue as a going concern in order to provide returns for shareholders and benefits for other stakeholders and to maintain an optimal capital structure to reduce the cost of capital.
The Company raises capital from the issue of equity, grants, licensing or borrowings. On a regular basis, management receives financial and operational performance reports that enable management to assess the adequacy of resources on hand and the Company’s liquidity position to determine future financing needs. For further information on financing needs refer to Note 2.
Fair values
Financial instruments measured at fair value in the unaudited condensed consolidated financial statements of financial position are grouped into three levels of fair value hierarchy. This grouping is determined based on the lowest level of significant inputs used in fair value measurement, as follows:
| 1. |
Level 1 – quoted prices in active markets for identical assets or liabilities. |
| 2. |
Level 2 – inputs other than quoted prices included within Level 1 that are observable for the instrument, either directly (i.e. as prices) or indirectly (i.e. derived from prices). |
| 3. |
Level 3 – inputs for instruments that are not based on observable market data (unobservable inputs). |
The following table summarizes the Company’s financial liabilities, and the category using the fair value hierarchy. Note, the Company did not have any financial assets measured at fair value, as of June 30, 2025, and December 31, 2024.
| June 30, 2025 |
||||||||||||
| Level 1 |
Level 2 |
Level 3 |
||||||||||
| (USD in thousands) |
||||||||||||
| Financial liabilities measured at fair value |
||||||||||||
| 2025 Investor Warrants |
$ | — | $ | — | $ | 1,131 | ||||||
| Total financial liabilities measured at fair value through profit or loss by level |
$ | — | $ | — | $ | 1,131 | ||||||
| Financial liabilities measured at amortized cost |
||||||||||||
| EIB Loan |
$ | — | $ | — | $ | 8,866 | ||||||
| Loan from lessor |
— | — | 826 | |||||||||
| Total financial liabilities measured at amortized cost by level |
$ | — | $ | — | $ | 9,693 | ||||||
| December 31, 2024 |
||||||||||||
| Level 1 |
Level 2 |
Level 3 |
||||||||||
| (USD in thousands) |
||||||||||||
| Financial liabilities measured at amortized cost |
||||||||||||
| EIB Loan |
$ | — | $ | — | $ | 8,143 | ||||||
| Loan from lessor |
— | — | 815 | |||||||||
| Total financial liabilities measured at amortized cost by level |
$ | — | $ | — | $ | 8,958 | ||||||
2025 Investor Warrants
As part of the January 2025 Public Offering, the Company issued warrants to all participating investors with an exercise price based on the traded price prevailing as of the issue date. As set out in IAS 32, the warrants were classified as derivative financial instruments due to the exercise price being denominated in a currency other than the Company’s functional currency, and therefore the fixed for fixed criteria was not met. As such, the warrants were deemed derivative liabilities at issuance, and the liability were measured and remeasured at their fair value. The fair value of the 2025 Investor Warrants were determined using a Black-Scholes valuation model, considering relevant inputs, including the expected share price volatility, remaining contractual term, risk-free interest rate and expected dividend.
As announced on May 27, 2025, the Company entered into an amendment to its 2025 Investor Warrants, with approximately 50% of the participating investors. The amendments convert the exercise price per ADS for the 2025 Investor Warrants from $2.71 to DKK 19.15 on average. As the converted awards are no longer settled in foreign currency, the converted warrants now meet the fixed for fixed criteria under IAS 32. This resulted in a change of classification of the awards from liability classification to equity classification. Due to the classification change, the converted portion of the derivative liability was reclassified to other reserves at the time of the amendment.
The following table sets forth the changes to the Company’s derivative liability related to the 2025 Investor Warrants:
| Derivative Liability |
||||
| (USD in thousands) |
||||
| Carrying amount at January 1, 2025 |
$ | — | ||
| Initial recognition of derivative liability |
3,929 | |||
| Remeasurement of derivative liability |
(1,916 | ) | ||
| Exercise of warrants |
(93 | ) | ||
| Reclassification of derivative liability |
(789 | ) | ||
| Carrying amount at June 30, 2025 |
$ | 1,131 | ||
The initial recognition and the reclassification are offset against other reserves. The net amount from derivative liabilities recorded as a non-cash adjustment to share premium amounts to $2.4 million and constitutes the difference between initial recognition $3.9 million, the balance of the amended awards of $0.8 million, amortization of the day one loss of the amended awards of $0.6 million, and exercised warrants in the period $0.1 million.
EIB Warrants
The Company received the proceeds from the drawing of the first tranche of the EIB Loan on February 17, 2022. In connection therewith, EIB received 351,036 EIB Warrants, at an exercise price of DKK 1 per warrant, which vested immediately, pursuant to the terms of a separate warrant agreement, the EIB Warrant Agreement. On October 3, 2024, the Company increased the number of shares issuable from the exercise of the EIB Warrants by 22,091 to 373,127 as an adjustment related to capital issuances that occurred during the year. The EIB Warrants are exercisable at any time after issuance either net in cash or through payment of the exercise price and receipt of shares. Therefore, the warrant liability is recognized in full upon issuance.
The Company issued warrants in connection with the EIB Loan Agreement. The EIB Warrants liability is measured in full upon issuance. The liability is measured initially at its fair value and is subsequently remeasured at the redemption amount. The liability is classified in Level 1 of the fair value hierarchy. The fair value of the warrants issued to EIB is currently lower than the exercise price and for that reason no liability is presented.
As the warrant liability is a non-cash financing cost the amount related to the initial recognition of the warrant liability is not included within the consolidated statements of cash flows.
There has been no change to the Company’s EIB Warrants Liability during the six months ended June 30, 2025. The following table sets forth the changes to the Company’s EIB Warrants liability during the six months ended June 30, 2024:
| Warrant Liability |
||||
| (USD in thousands) |
||||
| Carrying amount at January 1, 2024 |
$ | 190 | ||
| Remeasurement of warrant liability |
(138 | ) | ||
| Foreign currency translation |
(4 | ) | ||
| Carrying amount at June 30, 2024 |
$ | 48 | ||
Note 7. Borrowings
Loan from Lessor
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 Hørsholm, Denmark. In addition to the ordinary lease payments, the Company obtained financing from DTU Science Park A/S (“DTU”) for rebuilding the laboratory facility and engineering building to match the Company’s needs. The Company will repay the $1.3 million financing at a fixed interest rate of 6% over 8 years. If the lease is terminated due to default by the Company before the outstanding balance, including interest accrued, has been repaid, the remaining balance is due immediately. The finance liability is recorded at amortized cost, which approximates fair value at the time of issuance.
As a result of the structure of the DTU financing this amount is not included as Purchase of property, plant and equipment within the unaudited condensed consolidated interim statements of cash flows. The leasehold improvements recognized will be subject to adjustment when the actual costs incurred are made available from DTU.
EIB Loan
In August 2020, the Company entered into a loan agreement with EIB. The Company received proceeds €7.0 million (approximately $7.8 million) on February 17, 2022. The Company will repay the EIB Loan at a fixed interest rate of 3% per annum and a payment-in-kind interest rate of 4% per annum. The loan is amortized to maturity using an effective monthly interest rate of 0.79%. The loan is repayable in full six years after drawing down.
Borrowings are summarized as follows (in thousands):
| June 30, |
December 31, |
|||||||
| 2025 |
2024 |
|||||||
| Loan from lessor |
$ | 826 | $ | 815 | ||||
| EIB Loan |
8,389 | 7,352 | ||||||
| Total Borrowings |
9,215 | 8,167 | ||||||
| Less: Borrowings, current portion |
(184 | ) | (159 | ) | ||||
| Total Borrowings, non-current portion |
$ | 9,031 | $ | 8,008 | ||||
Note 8. 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 vested upon the closing of our initial public offering in February 2021 (“IPO”). 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 2022, 2021 and 2020 expire on December 31, 2031. Warrants granted in 2025, 2024 and 2023 expire on December 31, 2031. As of June 30, 2025, and 2024, the number of warrants as a percentage of outstanding ordinary shares was 4.3% and 1.4%, respectively.
The following schedule specifies the granted warrants:
| Number of |
Weighted Average Exercise | ||||
| Warrants |
Price/Share | ||||
| Warrants granted as at December 31, 202 |
3,044,794 | USD 1.19(1) |
|||
| Warrants granted |
1,372,407 | USD 0.07 |
|||
| Warrants forfeited |
(83,662 | ) | USD 0.23 |
||
| Warrants granted as at June 30, 2025 (3) |
4,333,539 | USD 0.86 (2) |
|||
| Warrants exercisable as at June 30, 2025 |
2,953,561 | USD 1.23 (2) |
|||
| Number of |
Weighted Average Exercise | ||||
| Warrants |
Price/Share | ||||
| Warrants granted as at December 31, 202 |
2,738,473 | USD 1.41(1) |
|||
| Warrants granted |
538,460 | USD 0.40 |
|||
| Warrants forfeited |
(84,559 | ) | USD 2.75 |
||
| Warrants granted as at June 30, 2024 (3) |
3,192,374 | USD 1.20 (2) |
|||
| Warrants exercisable as at June 30, 2024 |
2,258,206 | USD 1.02 (2) |
|||
(1) December 31, 2024 and 2023 USD-end rate used.
(2) June 30, 2023 and 2024 USD-end rate used.
(3) Number of warrants exclude non-employee warrants as referred to in Note 6.
For employee warrants, covering the three and six months ended June 30, 2025, a service cost of $0.1 million and $0.1 million has been recognized respectively, based on the estimated fair value of the warrants granted in prior periods and warrants expected to be granted. For the three and six months ended June 30, 2024, a service cost of $0.1 million and $0.2 million has been recognized respectively, based on the estimated fair value of the warrants granted in prior periods and warrants expected to be granted.
Determining the initial fair value and subsequent accounting for equity awards requires 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. Warrants are 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.
The following assumptions have been applied for the warrants issued during the six months ended June 30, 2025, and 2024, respectively:
| Six Months Ended June 30, |
||||||||
| 2025 |
2024 |
|||||||
| Expected term (in years) |
5.0 –7.0 | 5.0 –7.0 | ||||||
| Risk-free interest rate |
3.96% –4.09% | 4.71% –4.72% | ||||||
| Expected volatility |
85% | 85% | ||||||
| Share price |
$ | 0.05 | $ | 0.42 | ||||
Note 9. Financial Income and Expenses
| Three Months Ended |
Six Months Ended |
|||||||||||||||
| June 30, |
June 30, |
|||||||||||||||
| 2025 |
2024 |
2025 |
2024 |
|||||||||||||
| Financial income: |
||||||||||||||||
| Interest income, bank |
$ | 30 | $ | 41 | $ | 59 | $ | 95 | ||||||||
| Interest income, other |
— | — | 50 | — | ||||||||||||
| Foreign exchange gains |
208 | 131 | 208 | 203 | ||||||||||||
| Remeasurement of warrant obligation |
— | 48 | — | 172 | ||||||||||||
| Change in fair value of derivative liability |
308 | — | 2,722 | 5,368 | ||||||||||||
| Total financial income |
546 | 220 | 3,039 | 5,838 | ||||||||||||
| Financial expenses: |
||||||||||||||||
| Interest expenses |
(202 | ) | (185 | ) | (391 | ) | (374 | ) | ||||||||
| Interest expenses, lease liabilities |
(39 | ) | (40 | ) | (75 | ) | (81 | ) | ||||||||
| Remeasurement of warrant obligation |
— | (34 | ) | — | (34 | ) | ||||||||||
| Change in fair value of derivative liability |
(654 | ) | (1,654 | ) | (724 | ) | (1,654 | ) | ||||||||
| Foreign exchange losses |
(337 | ) | (123 | ) | (439 | ) | (139 | ) | ||||||||
| Total financial expenses |
(1,232 | ) | (2,036 | ) | (1,629 | ) | (2,282 | ) | ||||||||
| Net financial items |
$ | (686 | ) | $ | (1,816 | ) | $ | 1,410 | $ | 3,556 | ||||||
Note 10. Capital Structure and Financial Matters
Share Capital – Ordinary Shares
The following are changes in the Company’s share capital for the period ended June 30, 2025:
| Number of Ordinary Shares |
Share Capital (DKK in thousands) |
|||||||
| Share capital, December 31, 2024 |
70,130,556 | 70,131 | ||||||
| Capital increase at January 8, 2025 (exercised warrants) |
6,360,000 | 6,360 | ||||||
| Capital increase at January 16, 2025 (exercised warrants) |
2,150,000 | 2,150 | ||||||
| Capital decrease at January 17, 2025 |
— | (58,980 | ) | |||||
| Capital increase at January 24, 2025 (JonesTrading sales agreement) |
34,820,000 | 8,705 | ||||||
| Capital increase at January 31, 2025 (Public offering) |
177,451,100 | 44,362 | ||||||
| Capital increase at January 31, 2025 (Public offering) |
22,416,952 | 5,604 | ||||||
| Capital increase at February 5, 2025 (exercised warrants) |
2,500,000 | 625 | ||||||
| Share capital, June 30, 2025 |
315,828,608 | 78,957 | ||||||
January 2025 Capital Reduction
On January 17, 2025, the Company completed a 0.75 DKK decrease in the nominal value of capital per share, from 1 DKK to 0.25 DKK per share. The share capital reserve recognized was thus decreased from 78,640 (DKK in thousands) to 19,660 (DKK in thousands). The number of shares remained static at 78,640,556.
January 2025 Offering
In January 2025, the Company completed a public offering through which the Company offered 199,868,050 shares represented by 3,997,361 ADSs, DKK 0.25 nominal value per share, together with warrants to purchase up to 50% of the ADSs offered at a combined public offering price of $2.71 per ADS with one accompanying warrant for each two ADSs. The warrants are immediately exercisable for a term of five years from the date of issuance. The Company received gross proceeds of $10.8 million from the public offering.
JonesTrading Sales Agreement
On January 24, 2025, the Company sold 34,820,000 ordinary shares represented by ADSs, DKK 0.25 nominal value with fifty ordinary shares represented by one ADS, at a price of $7.17 per ADS. Gross proceeds from the sale of ordinary shares represented by ADSs were approximately $5.0 million. In connection with the sale, the Company registered aggregate share capital increase of nominal DKK 34,820,000. The ordinary shares represented by ADSs were sold pursuant to the Sales Agreement with JonesTrading dated October 3, 2022. This concluded sales under the Sales Agreement dated October 3, 2022, after which no shares remain for sale under this agreement.
Note 11. Commitments and Contingencies
Legal Proceedings
The Company may, from time to time, be involved in legal proceedings and claims that arise in the ordinary course of business. The Company believes that any adverse outcome of existing claims, individually or in the aggregate, would not have a material effect on its unaudited condensed consolidated interim financial statements.
Note 12. Events After the Reporting Period
No events have occurred after the balance sheet date that affects the financial performance and positions disclosed in these condensed consolidated interim financial statements.
July 11, 2025, Evaxion and the European Investment Bank (EIB) have finalized a debt settlement agreement where EIB will convert €3.5 million of its €7 million loan to Evaxion into equity via a purchase of ordinary Evaxion warrants at a price of $4.87, corresponding to a premium of 89% to the share price by market close July 11, 2025. The agreement immediately increases Evaxion’s equity by $4.1 million (€3.5 million), bolstering Evaxion’s capital structure. Further, it substantially reduces Evaxion’s overall liabilities, simplifies its balance sheet and improves its financial flexibility and cash flow.
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, 2024 – “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 IFRS Accounting 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 USD at an assumed exchange rate of DKK 6.366 per $1.00, which was the official exchange rate of such currencies as of June 30, 2025, rounded to three 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; |
|
● |
the development of and projections relating to our competitors or our industry; |
|
● |
our or our collaborators’ 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, Europe, Australia and other foreign countries; |
|
● |
our ability to manufacture our product candidates with advantages in turnaround times or manufacturing cost; |
|
● |
our ability to have our product candidates manufactured by third parties/collaborators or partners 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; |
|
● |
adverse effects on our business condition and results for operation from general economic and market conditions and overall fluctuations in the United States and international equity markets, including deteriorating market conditions due to investor concerns regarding inflation the effects on our business of the worldwide pandemics and the ongoing conflict in the region surrounding Ukraine and Russia and the ongoing conflict between Israel and Hamas; 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, 2024 — “Item 3. Key Information—D. Risk Factors”. You are urged to consider these factors carefully when evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this report. Except as required by law, we are under no obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise. 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 refer to 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 U.S. Securities and Exchange Commission, or the SEC, after the date of this report. We qualify all of our forward-looking statements by these cautionary statements.
Significant Risks and Uncertainties
As a TechBio company, we face a number of risks and uncertainties. These are common for the biopharmaceutical industry and relate to operations, research and development, commercial and financial activities. The Company expects to have sufficient funds into mid-2026. Information on liquidity and going concern we refer to Note 2 to the condensed consolidated financial statements. For further information about risks and uncertainties the Company faces, we refer to our Annual Report on Form 20-F for the year ended December 31, 2024, filed with the SEC on April 1, 2025. In addition to the risk profile described in Form 20-F the below developments should be observed.
Recent Developments
Business Highlights Since Last Quarterly Update
Since the Q1 2025 financial results were released, the Company has continued to make progress on its multi-partner approach to value realization through the company’s multidisciplinary capabilities and the unique predictive capabilities of AI-Immunology™. Key highlights include:
|
● |
Evaxion continues to execute its strategy and plans with a number of significant achievements across the company in recent months. The Company remains on track to achieve the milestones set for 2025 |
|
● |
New immune data from the ongoing phase 2 trial with EVX-01 was presented at the American Association for Cancer Research (AACR) Annual Meeting in April 2025, with data demonstrating 80% vaccine targets triggered a tumor-specific immune response. The full two-year clinical efficacy dataset will be presented at an oral presentation at the ESMO Congress in October 2025 |
|
● |
The one-year extension of the EVX-01 phase 2 trial has completed the recruitment of patients May 2025 |
|
● |
Grant funding received in June 2025 from the Gates Foundation to help the world eradicate polio (poliomyelitis) by exploring design options for a new and unique vaccine |
|
● |
Expansion of R&D pipeline with EVX-B4, a new vaccine program against Group A Streptococcus (GAS) announced in June 2025 |
|
● |
Birgitte Rønø has taken the role of interim CEO, following Christian Kanstrup who stepped down as of June 30, 2025. The Company’s strategy, tactical plans and anticipated milestones are unchanged |
|
● |
Agreement finalized with the European Investment Bank (EIB) in July 2025, to convert debt into equity of €3.5 million. The agreement immediately improves the Company’s equity, financial flexibility and cash flow, while substantially reducing overall liabilities and simplifying the balance sheet |
Results of Operations
Comparison of the three months ended June 30, 2025 and 2024
The following table summarizes our statements of profit or loss for the periods indicated (unaudited):
|
Three Months Ended June 30, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(USD in thousands) |
||||||||||||
|
Operating expenses: |
||||||||||||
|
Revenue |
$ | 37 | $ | 154 | $ | (117 | ) | |||||
|
Research and development |
(2,165 | ) | (2,752 | ) | 587 | |||||||
|
General and administrative |
(2,212 | ) | (1,983 | ) | (229 | ) | ||||||
|
Operating loss |
(4,340 | ) | (4,581 | ) | (241 | ) | ||||||
|
Finance income |
546 | 220 | (326 | ) | ||||||||
|
Finance expenses |
(1,232 | ) | (2,036 | ) | 804 | |||||||
|
Net loss before tax |
(5,026 | ) | (6,397 | ) | (1,371 | ) | ||||||
|
Income tax benefit |
195 | 199 | 4 | |||||||||
|
Net loss for the period |
$ | (4,831 | ) | $ | (6,198 | ) | $ | (1,367 | ) | |||
Revenue
Revenue was nominal for the three months ended June 30, 2025, and primarily relates to a grant received from the Gates Foundation.
Research and Development
Research and development expenses were $2.2 million for the three months ending June 30, 2025, as compared to $2.8 million for the three months ending June 30, 2024. The decrease was primarily due to lower external costs related to clinical trials.
General and Administrative
General and administrative expenses were $2.2 million for the three months ending June 30, 2025, as compared to $2.0 million for the three months ending June 30, 2024. The increase is primarily driven by capital market transaction costs and increased investor relations activities.
Net Financial Expenses
Net Financial Expenses of $0.7 million mainly related to net change in fair value of derivative liability due to changes in the Company’s share price and the DKK USD exchange rate.
Income Taxes
The benefits from income tax were $0.2 million for the three months ending June 30, 2025, at same level for the three months ended June 30, 2024. Taxable income is mainly related to expected tax receivable from R&D Tax Schemes in Denmark and Australia based on tax losses incurred in the current financial year.
Comparison of the six months ended June 30, 2025 and 2024
The following table summarizes our statements of profit or loss for the periods indicated (unaudited):
|
Six Months Ended June 30, |
||||||||||||
|
2025 |
2024 |
Change |
||||||||||
|
(USD in thousands) |
||||||||||||
|
Operating expenses: |
||||||||||||
|
Revenue |
$ | 37 | $ | 205 | $ | (168 | ) | |||||
|
Research and development |
(4,321 | ) | (5,588 | ) | 1,267 | |||||||
|
General and administrative |
(3,924 | ) | (3,594 | ) | (330 | ) | ||||||
|
Operating loss |
(8,208 | ) | (8,977 | ) | 769 | |||||||
|
Finance income |
3,039 | 5,838 | (2,799 | ) | ||||||||
|
Finance expenses |
(1,629 | ) | (2,282 | ) | 653 | |||||||
|
Net loss before tax |
(6,798 | ) | (5,421 | ) | (1,377 | ) | ||||||
|
Income tax benefit |
387 | 417 | 30 | |||||||||
|
Net loss for the period |
$ | (6,411 | ) | $ | (5,004 | ) | $ | (1,407 | ) | |||
Revenue
Revenue was nominal for the six months ended June 30, 2025, compared to $0.2 million same period last year. The revenue in 2025 mainly relates to grant received from the Gates Foundation.
Research and Development
Research and development expenses were $4.3 million for the six months ending June 30, 2025, as compared to $5.6 million for the six months ending June 30, 2024. The decrease was primarily due to lower external costs related to clinical trials.
General and Administrative
General and administrative expenses were $3.9 million for the six months ended June 30, 2025, as compared to $3.6 million for the six months ended June 30, 2024. The increase mainly relates to external cost and professional fees.
Net Financial Income
Net Financial Income of $1.4 million mainly related to net change in fair value of derivative liability due to changes in the Company’s share price and the DKK USD exchange rate.
Income Taxes
The benefits from income tax were $0.4 million for the six months ended June 30, 2025. Taxable income is mainly related to expected tax receivable from R&D Tax Schemes in Denmark and Australia based on tax losses incurred in the current financial year.
Liquidity and Capital Resources
Overview
As a pioneering TechBio company using artificial intelligence to decode the human immune system and develop novel vaccines for cancer, bacterial diseases, and viral infections 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 June 30, 2025, we had an accumulated deficit of $124.9 million and expect to continue to incur losses for the foreseeable future.
As of June 30, 2025, and December 31, 2024, our available liquidity, comprised of cash and cash equivalents, was $14.7 million and $6.0 million, respectively.
As of June 30, 2025, and December 31, 2024, our total equity was $6.2 million and a deficit of $1.7 million, respectively. We generated a nominal amount of revenue during the six months ending June 30, 2025, compared to $0.2 million during the six months ending June 30, 2024.
We monitor our funding situation closely to ensure that we have access to sufficient liquidity to meet our forecasted cash requirements. Analyses are run to reflect different scenarios including, but not limited to, cash runway, human capital resources and pipeline priorities to identify liquidity risk. This enables Management and the Board of Directors to prepare for new financing transactions and/or adjust the cost base accordingly.
We have funded our operations primarily through the issuance of equity, with the latest Public Offering successfully completed January 31, 2025, with gross proceeds of $10.8 million. Earlier in January 2025 exercise of prefunded warrants and sales of American Depositary Shares through Evaxion’s ATM facility had also bolstered the company’s equity by approximately $7.6 million. In total, these capital market activities provided a net total of approximately $17.0 million in cash and equity, extending Evaxion’s cash runway to mid-2026.
We are encouraged by our business development pipeline and are still targeting at least two new agreements for 2025. However, it is also clear that the current turmoil in the financial markets and increased regulatory uncertainty is having an impact on the decision processes with some potential partners. To mitigate the risk of not meeting our business development target, we are focusing our partnering efforts on potential partners who are expected to be less impacted by the current turmoil. Any such agreement will, when completed, extend our cash runway beyond mid-2026.
Our funding strategy is to balance the funding of cash needs through equity offerings, or other capital sources in case this is not covered by income from potential collaborations or licenses.
On July 31, 2023, we entered into a financing agreement with Global Growth Holding Limited (“GGH”), for the issuance of convertible notes into our ordinary shares represented by ADSs, DKK 1 nominal value, with each ordinary share represented by one ADSs. Pursuant to the agreement, we may elect to sell to GGH up to $20.0 million in such notes on any business day over the 36-month term of the agreement. We have under certain circumstances the right, but not the obligation to direct GGH to purchase tranches of up to $0.7 million, subject to certain limitations and conditions set forth in the agreement. In connection with the agreement, we are obliged to pay GGH a commitment fee totaling $1.1 million. At any time, GGH may, in its sole discretion, convert the notes into ordinary shares at specified conversion prices upon submission of a request for conversion by GGH to us. The financing agreement between us and GGH is subject to approval by the SEC through the date of issuance of this report.
January 14, 2025, the Company made effective a change to its ratio of ADSs to its ordinary shares, DKK 1 nominal value (the “ADS Ratio”). The ratio has been changed from one ADS representing ten (10) ordinary share to a new ADS Ratio of one ADS representing fifty (50) ordinary shares of the Company. Unless specified otherwise, all references in this annual report to ADS share and ADS per share data have been adjusted, including historical data which has been retroactively adjusted, to give effect to the ADS Ratio change.
January 17, 2025, an extraordinary general meeting of Evaxion was held, where it was approved to reduce our share capital by nominal DKK 58,980,417 from nominal DKK 78,640,556 to nominal DKK 19,660,139 to cover loss. Furthermore, it was approved to reduce the nominal value of the shares from nominal DKK 1 per share to nominal DKK 0.25 per share, and our Article of Association were amended accordingly.
January 24, 2025, the Company sold 696,400 ADSs at an average price of USD $7.1776 per ADS. The ADSs were sold in an at-the-market (ATM) offering pursuant to the terms and subject to the conditions contained in that certain Capital Demand Sales Agreement between the Company and Jones Trading Institutional Services LLC dated October 3, 2022. Total gross proceeds from the sales of the ADSs were approximately $5.0 million.
January 31, 2025, the Company closed its public offering of an aggregate of 3,997,361 of its ADSs and warrants to purchase up to 50% of the ADSs offered at a combined public offering price of $2.71 per ADS with one accompanying warrant for each two ADSs, with gross proceeds of $10.8 million. The Company registered aggregate share capital increases of nominal DKK 49,967,012.50 with the Danish Business Authority, with effective date of January 31, 2025, corresponding to an aggregate increase in the Company’s share capital to nominal DKK 78,332,151.50. This reflected issuances of 199,868,050 shares in connection with the public offering.
Financing Requirements
We anticipate incurring additional losses until such time, if ever, we can complete our research and development activities and obtain out-licensing partnerships for our product candidates and generate revenues from such product candidates. Additional financing will be needed by us to fund our operations and to continue the development of our product candidates.
We monitor our funding situation closely to ensure we have access to sufficient liquidity to meet our forecasted cash requirements. Analyses are run to reflect different scenarios including, but not limited to, cash runway, human capital resources and pipeline priorities to identify liquidity risk. This enables Management and the Board of Directors to prepare for new financing transactions and/ or adjust the cost base accordingly. With our current strategic plans, we anticipate that with the current cash position and the forecast cash requirements, we will have sufficient cash to fund operations into mid-2026.
Accordingly, unaudited condensed consolidated financial statements have been prepared on a basis as a going concern, and which contemplates the realization of assets and discharge of liabilities and commitments in the normal course of business. We may seek additional capital if market conditions are favorable or if we have specific strategic considerations as well as operational requirements. Our spending will vary based on new and ongoing development and corporate activities. Due to high level of uncertainty of the length of time and activities associated with discovery and development of our product candidates, we are unable to estimate the actual amount of funds we will require for our developmental activities.
Our 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; |
|
● |
our ability to establish and maintain collaborations, 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 climate change on our business operations; |
|
● |
the effects of the continuing hostilities between Ukraine and Russia, and between Israel and Hamas, along with the retaliatory measures by the global community have created global security concerns, including the possibility of expanded regional or global conflict, which have had, are likely to continue to have, short-term and likely longer-term adverse impacts on Europe and around the globe; |
|
● |
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 may be unable to raise additional funds or enter 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 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 our product candidate development or grant rights to develop and market our product.
If we are unable to obtain additional financing on a timely basis we may be required to file for reorganization or liquidation under applicable reorganization or bankruptcy laws.
Cash Flows
The following table summarizes our cash flow for the periods indicated (unaudited):
|
Six Months Ended June 30, |
||||||||
|
2025 |
2024 |
|||||||
|
(USD in thousands) |
||||||||
|
Cash Flow Data: |
||||||||
|
Net cash used in operating activities |
$ | (7,724 | ) | $ | (8,985 | ) | ||
|
Net cash used in investing activities |
(3 | ) | (3 | ) | ||||
|
Net cash provided by financing activities |
15,593 | 11,394 | ||||||
|
Net change in cash and cash equivalents |
$ | 7,866 | $ | 2,406 | ||||
Operating Activities
Net cash used in operating activities was $7.7 million for the six months ending June 30, 2025. The largest component of our cash used in operating activities during this period was a net loss for the period of $6.4 million and non-cash adjustments of $1.4 million, offset by $0.1 million of interest received. The non-cash charges primarily consisted of a gain from changes in fair value of liability-classified warrants of $2.0 million.
Net cash used in operating activities was $9.0 million for the six months ending June 30, 2024. The largest component of our cash used in operating activities during this period was a net loss for the period of $5.0 million and non-cash adjustments of $3.5 million, offset by $0.1 million of interest received. The non-cash charges primarily consisted of a gain from changes in fair value of liability-classified warrants of $3.7 million, income tax benefit of $0.4 million, and exchange rate adjustments and other immaterial changes of $0.1 million. These non-cash charges were offset by non-cash interest expense of $0.4 million, share-based compensation expense of $0.1 million, and depreciation and amortization 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 due to the timing and payment of invoices received from various minor items.
Investing Activities
Net cash used in investing activities for the six months ending June 30, 2025, was nominal and primarily driven by the purchase of property and equipment.
Financing Activities
Net cash provided by financing activities was $15.6 million for the six months ending June 30, 2025, primarily related to proceeds from the January 2025 Public Offering and the JonesTrading arrangement.
Off-balance Sheet Arrangements
As of June 30, 2025, 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 expenditure in foreign currencies, mainly the USD. This exposure is known as transaction exposure. We are exposed to foreign currency risk because 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. For the six months ending June 30, 2025, we experienced a net foreign exchange loss of $0.2 million, whereas the same period in 2024 showed a gain of $0.1 million. We believe a 10% change in foreign exchange rate would not have a material impact on our operating results.
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 a 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 3 to our audited consolidated financial statements in our Annual Report on Form 20-F for the year ended December 31, 2024.