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Evaxion to present a breadth of data from phase 2 trial with AI-designed personalized cancer vaccine EVX-01 at the ESMO Congress 2025
Globenewswire· 2025-10-13 12:00
Core Insights - Evaxion A/S will present data from its phase 2 trial of the personalized cancer vaccine EVX-01 at the ESMO Congress 2025, highlighting its clinical efficacy, immunogenicity, and safety [1][2][10] Group 1: Presentation Details - The presentation will include two-year clinical efficacy, immunogenicity, and safety data, focusing on overall response rates, deepened response rates, and durability of response [2][10] - The oral session is scheduled for October 17, 2025, at 14:10 CEST, with Dr. Muhammad Adnan Khattak as the presenter [8][10] Group 2: Clinical Trial Insights - EVX-01, designed using Evaxion's AI-Immunology™ platform, is being evaluated for advanced melanoma treatment, showing a 69% overall response rate in previous trials [5][6] - The phase 2 trial combines EVX-01 with MSD's KEYTRUDA® (pembrolizumab), with each vaccine tailored to the individual patient's biology [7] Group 3: Company Background - Evaxion is a clinical-stage TechBio company focused on AI-powered vaccines, with a commitment to developing personalized immunotherapies for cancer and infectious diseases [14]
Evaxion expands AI-Immunology™ platform with automated vaccine design module
Globenewswire· 2025-10-08 12:12
Core Insights - Evaxion A/S is launching a new automated vaccine design module as an enhancement to its AI-Immunology™ platform, aimed at improving vaccine development efficiency and quality [1][4][7] - The new module automates the entire process of target discovery and vaccine design, significantly reducing design time from months to days and offering cost savings [2][3][7] - The module can be applied to both new and existing vaccines, potentially leading to the development of improved vaccine generations [5][7] Group 1 - The new automated design module ensures optimal sequence and conformation of vaccine targets, enhancing protective immune responses [2][3] - The launch of this module is a milestone for Evaxion in 2025, enhancing its value proposition to potential partners and expanding in-house capabilities [4][5] - Evaxion plans to present validation data on the improvements at the World Vaccine Congress Europe on October 15, 2025 [5][7] Group 2 - Evaxion is a clinical-stage TechBio company focused on AI-powered vaccine development, with a pipeline addressing high unmet medical needs in oncology and infectious diseases [6] - The AI-Immunology™ platform utilizes AI to decode the human immune system, facilitating the development of novel immunotherapies [6] - The company is committed to transforming patient care through innovative and targeted treatment options [6]
Evaxion to present new biomarker data for AI-designed personalized cancer vaccine EVX-01 at the SITC 2025 Annual Meeting
Globenewswire· 2025-10-03 13:00
Core Insights - Evaxion A/S is set to present new data for its lead asset EVX-01, a personalized cancer vaccine, at the Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting [1] - The ongoing phase 2 trial of EVX-01 is investigating its efficacy in combination with Merck's KEYTRUDA® for advanced melanoma patients [3][5] - EVX-01 has shown promising results with overall response rates of 69% and 67% in advanced melanoma patients [6] Presentation Details - New biomarker and immune data from the phase 2 trial will be presented at SITC 2025, with two-year clinical efficacy data to be shared at the ESMO 2025 congress on October 17, 2025 [2][8] - The SITC presentation will include an abstract titled "Immune correlates of clinical response following treatment with the personalized cancer vaccine EVX-01 and Pembrolizumab in advanced melanoma patients" [9] About EVX-01 - EVX-01 is designed using Evaxion's AI-Immunology™ platform, targeting the unique tumor profile and immune characteristics of each patient [5][10] - The vaccine aims to engage the patient's immune system to mount a targeted response against tumors, representing a first-line treatment option for multiple advanced solid cancers [5] Clinical Trial Insights - The phase 2 trial combines EVX-01 with KEYTRUDA®, allowing for a personalized approach to treatment based on individual patient biology [3] - The trial has already provided strong one-year interim data, contributing to a robust data package for EVX-01 [2][8]
Evaxion A/S - Special Call
Seeking Alpha· 2025-09-25 15:07
Core Insights - Evaxion has achieved a significant milestone by having MSD (Merck) exercise its option to license the EVX-B3 vaccine candidate, marking the first instance of a pharmaceutical company in-licensing a vaccine candidate discovered using AI [3] Company Updates - The licensing of EVX-B3 is a notable achievement for Evaxion and highlights the potential of AI-driven drug development in the pharmaceutical industry [3] - MSD also holds an option on another vaccine candidate, EVX-B2, with an extended evaluation period and a decision on potential in-licensing expected in the first half of 2026 [4]
Evaxion out-licenses vaccine candidate EVX-B3 to MSD
Globenewswire· 2025-09-25 11:00
Core Insights - Evaxion A/S has out-licensed its vaccine candidate EVX-B3 to MSD, receiving an initial cash payment of $7.5 million and potential future payments totaling up to $592 million [1][2][10] - The EVX-B3 vaccine, currently in preclinical development, targets a pathogen linked to serious medical complications and aims to address a significant global health issue [3][4] - The collaboration with MSD validates Evaxion's AI-Immunology™ platform, which has identified novel vaccine targets for challenging pathogens [4][5] Financial Implications - The cash payment extends Evaxion's cash runway into the first half of 2027, allowing continued investment in its AI-Immunology™ platform and R&D projects [6] - Future milestone payments from MSD for EVX-B3 could reach up to $592 million, along with royalties on net sales [2][10] - Should MSD exercise its option on EVX-B2, Evaxion would receive an additional cash payment of $2.5 million and similar milestone and royalty structures as with EVX-B3 [9][10] Development and Collaboration - The collaboration between Evaxion and MSD began in September 2023 and has now expanded to include EVX-B2, a preclinical vaccine candidate against Gonorrhea [7][8] - The evaluation period for EVX-B2 has been extended, with a decision on potential licensing expected in the first half of 2026 [8][9] - MSD will assume full responsibility for the further development of EVX-B3, allowing Evaxion to focus on its strategic partnerships [2][10]
Evaxion to present at several conferences during the second half of 2025
Globenewswire· 2025-08-27 12:00
Core Insights - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines and will present updates at various conferences in the latter half of 2025 [1][3][7] Company Updates - The company will engage with stakeholders and potential partners at multiple conferences across the US, Europe, and Asia to explore business partnerships and scientific collaborations [2][5] - Evaxion is particularly excited about presenting two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO congress in October 2025 [3][5] Conference Participation - Evaxion's conference schedule includes: - Vaccine Congress, September 7-10, Kyoto - HC Wainwright Global Investment Conference, September 8-10, New York - ESCMID Conference on vaccines, September 10-13, Lisbon - Lake Street Best Ideas Growth Conference, September 12, New York - HC Andersen seminar, September 18, Copenhagen - Vax On Vaccines: Present and future in oncology, October 1, Milan - BiotechX Europe, October 6-8, Basel - World Vaccine Congress Europe, October 14-16, Amsterdam - ESMO Congress 2025, October 17-21, Berlin - Society for Immunotherapy of Cancer (SITC) 2025, November 5-9, National Harbor - Vaccines Summit, November 13-15, Boston - NextGen Omics, November 13-14, London [5][6] Company Background - Evaxion utilizes its proprietary AI platform, AI-Immunology™, to develop novel immunotherapies targeting cancer, bacterial diseases, and viral infections, aiming to transform patient care with innovative treatment options [6][7]
Evaxion(EVAX) - 2025 Q2 - Earnings Call Transcript
2025-08-14 13:30
Financial Data and Key Metrics Changes - The company reported a cash position of $14.7 million as of June, with an expected operating cash burn of approximately $14 million, providing a runway until mid-2026 [13][18] - The operating loss for Q2 was $4.3 million, compared to $4.6 million in the same period last year, indicating a slight improvement [15][16] - The net loss for the quarter was $4.8 million, down from $6.2 million in the same period last year, primarily due to lower net financial expenses [16] Business Line Data and Key Metrics Changes - The company has expanded its R&D pipeline with the addition of EVX004 and EVX B4 programs, focusing on cancer and infectious diseases [4][8] - The EVX-one program is currently in Phase II clinical development, with a two-year data presentation scheduled for the ESMO Congress in October [6][7] Market Data and Key Metrics Changes - The company has received a grant from the Gates Foundation for a polio vaccine project, which is expected to enhance its market presence and attract further partnerships [5][8] - The partnership with MSD is progressing, with potential option exercises anticipated in 2025 [4][19] Company Strategy and Development Direction - The company is actively seeking partnerships to advance its clinical development towards registration, particularly for the EVX-one program [7][8] - Business development remains a key priority, with multiple partnership discussions ongoing across its R&D pipeline [19] Management Comments on Operating Environment and Future Outlook - Management acknowledged the challenging financial markets and increased regulatory uncertainty impacting deal execution [4] - The company remains optimistic about its operational momentum and potential value catalysts, with cash reserves sufficient to support operations until mid-2026 [19] Other Important Information - The company converted €3.5 million of its loan from the European Investment Bank into equity, strengthening its capital structure [12][18] - The total equity as of June was reported at $6.2 million, which is expected to increase following the equity conversion [15][17] Q&A Session Summary Question: What remaining steps are there for Merck to decide on the option for the programs? - The company is on track with timelines for both collaborations with Merck, with promising data generated and expected conclusions in 2025 [21][23] Question: What is the focus of the business development conversations? - Discussions are ongoing across both oncology and infectious disease areas, with a focus on target discovery collaborations using AI immunology [24] Question: How will the two-year data compare to the one-year data for EVX-one? - The two-year data has not yet been disclosed, but the company has gathered additional information since the one-year data, with 11 patients still active in the trial [28][30]
Evaxion(EVAX) - 2025 Q2 - Quarterly Report
2025-08-14 11:30
[Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss](index=2&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Comprehensive%20Loss) The interim comprehensive loss statements show a reduced net loss for the three months ended June 30, 2025, but an increased net loss for the six-month period [Comprehensive Loss Analysis](index=2&type=section&id=Comprehensive%20Loss%20Analysis) For the three months ended June 30, 2025, Evaxion Biotech A/S reported a net loss of $4.831 million, an improvement from $6.198 million in the prior year period; the operating loss also decreased to $4.340 million from $4.581 million; for the six months ended June 30, 2025, the net loss increased to $6.411 million from $5.004 million, primarily due to a significant decrease in finance income, despite a reduction in operating loss Statements of Comprehensive Loss (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Revenue | $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 | $546 | $220 | $3,039 | $5,838 | | Finance expenses | $(1,232) | $(2,036) | $(1,629) | $(2,282) | | Net loss for the period | $(4,831) | $(6,198) | $(6,411) | $(5,004) | | Total comprehensive loss | $(4,162) | $(6,170) | $(5,892) | $(4,894) | | Loss per share – basic and diluted | $(0.02) | $(0.12) | $(0.03) | $(0.10) | [Unaudited Condensed Consolidated Interim Statements of Financial Position](index=3&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) This section outlines the interim financial position, showing significant asset growth and a shift to positive equity as of June 30, 2025 [Financial Position Overview](index=3&type=section&id=Financial%20Position%20Overview) As of June 30, 2025, Evaxion Biotech A/S significantly strengthened its financial position, with total assets increasing to $22.449 million from $12.485 million at December 31, 2024; this was primarily driven by a substantial increase in cash and cash equivalents and prepayments; total equity shifted from a deficit of $1.652 million to a positive $6.226 million, while total liabilities also increased to $16.223 million Statements of Financial Position (USD in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------- | :------------ | :---------------- | | **ASSETS** | | | | Total non-current assets | $4,272 | $3,720 | | Total current assets | $18,177 | $8,765 | | **TOTAL ASSETS** | **$22,449** | **$12,485** | | **EQUITY (DEFICIT) AND LIABILITIES** | | | | Share capital | $11,823 | $10,516 | | Other reserves | $119,351 | $106,369 | | Accumulated deficit | $(124,948) | $(118,537) | | Total equity (deficit) | $6,226 | $(1,652) | | Total non-current liabilities | $10,901 | $9,769 | | Total current liabilities | $5,322 | $4,368 | | **Total liabilities** | **$16,223** | **$14,137** | | **TOTAL EQUITY AND LIABILITIES** | **$22,449** | **$12,485** | - Cash and cash equivalents increased significantly to **$14.746 million** as of June 30, 2025, from **$5.952 million** at December 31, 2024[7](index=7&type=chunk) [Unaudited Condensed Consolidated Interim Statements of Changes in Equity (Deficit)](index=4&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Equity%20%28Deficit%29) This section analyzes interim equity changes, highlighting a significant improvement to positive equity driven by share issuance for cash [Equity Changes Analysis](index=4&type=section&id=Equity%20Changes%20Analysis) For the six months ended June 30, 2025, total equity (deficit) improved significantly to $6.226 million from a deficit of $1.652 million at December 31, 2024; this positive change was primarily driven by the issuance of shares for cash, which contributed $17.828 million, and other comprehensive income of $519 thousand, partially offset by a net loss of $6.411 million and non-cash effects from derivative liabilities and transaction costs Statements of Changes in Equity (Deficit) (USD in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :----------------------------- | :----------------------------- | | Equity at December 31 | $(1,652) | $(4,729) | | Net loss for the period | $(6,411) | $(5,004) | | Other comprehensive income | $519 | $110 | | Share-based compensation | $131 | $101 | | Issuance of shares for cash | $17,828 | $14,182 | | Non-cash effect from issue of investor warrants classified as derivative liability | $(2,432) | $(1,097) | | Transaction costs | $(1,757) | $(2,310) | | Equity at June 30 | $6,226 | $1,253 | [Unaudited Condensed Consolidated Interim Statements of Cash Flows](index=5&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Cash%20Flows) This section details interim cash flows, showing a significant net increase in cash and cash equivalents driven by financing activities [Cash Flow Analysis](index=5&type=section&id=Cash%20Flow%20Analysis) For the six months ended June 30, 2025, Evaxion Biotech A/S experienced a net increase in cash and cash equivalents of $7.866 million, a significant improvement compared to a $2.406 million increase in the prior year period; this was primarily driven by a substantial increase in cash provided by financing activities, which reached $15.593 million, largely from the issuance of shares and exercise of warrants Statements of Cash Flows (USD in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------- | :----------------------------- | :----------------------------- | | Net loss for the period | $(6,411) | $(5,004) | | 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 increase in cash and cash equivalents | $7,866 | $2,406 | | Cash and cash equivalents at January 1 | $5,952 | $5,583 | | Cash and cash equivalents at June 30 | $14,746 | $7,993 | [Notes to Unaudited Condensed Consolidated Interim Financial Statements](index=6&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section provides detailed notes to the interim financial statements, covering company information, accounting policies, financial instruments, and significant events [Note 1. General Company Information](index=6&type=section&id=Note%201.%20General%20Company%20Information) Evaxion Biotech A/S is a clinical-stage TechBio company leveraging its AI-Immunology™ platform to develop novel vaccines for cancer, bacterial, and viral infections; the platform has demonstrated a link between AI predictions and clinical response in metastatic melanoma patients, aiming to reduce development costs and risks; partnerships are a key strategy for realizing value - Evaxion Biotech A/S is a clinical-stage TechBio company utilizing its AI-Immunology™ platform to develop novel vaccines for various cancers, bacterial, and viral infections[14](index=14&type=chunk) - The AI-Immunology™ platform has shown a link between AI predictions and clinical response in metastatic melanoma cancer patients, aiming to reduce development costs and risks[14](index=14&type=chunk) - Partnerships are a key element in the company's strategy to realize the value of its AI-Immunology™ opportunities[14](index=14&type=chunk) [Note 2. Liquidity and Going Concern Assessment](index=6&type=section&id=Note%202.%20Liquidity%20and%20Going%20Concern%20Assessment) Management and the Board of Directors are confident in the Company's ability to continue as a going concern, with sufficient cash to finance operations into mid-2026; this confidence is bolstered by successful public and at-the-market (ATM) offerings in January 2025, securing $10.8 million and $5.0 million respectively; the Company also has an ATM program with JonesTrading and a convertible notes agreement with Global Growth Holding Limited (GGH) for potential future financing - Management and the Board of Directors believe the Company has adequate resources to meet its obligations and continue operations into **mid-2026**[16](index=16&type=chunk) - In January 2025, the Company secured **$10.8 million** from a public offering and approximately **$5.0 million** from an at-the-market (ATM) offering[16](index=16&type=chunk)[23](index=23&type=chunk)[72](index=72&type=chunk) - The Company has a 'Capital on Demand™ Sales Agreement' with JonesTrading for ATM offerings and a financing agreement with Global Growth Holding Limited (GGH) for up to **$20.0 million** in convertible notes[18](index=18&type=chunk)[20](index=20&type=chunk) - On January 17, 2025, the Company approved a reduction in share capital by **DKK 58,980,417** to cover losses and reduced the nominal value of shares from **DKK 1** to **DKK 0.25** per share[21](index=21&type=chunk)[70](index=70&type=chunk) [Note 3. Summary of Significant Accounting Policies](index=8&type=section&id=Note%203.%20Summary%20of%20Significant%20Accounting%20Policies) The unaudited condensed consolidated interim financial statements are prepared in accordance with IAS 34, consistent with IFRS accounting standards; the adoption of amendments to IAS 21 regarding 'Lack of Exchangeability' on January 1, 2025, did not materially impact the Company's financial statements; no other new IFRS or IFRIC interpretations effective during the period had a material impact, and future standards are not expected to have a significant impact - Financial statements are prepared in accordance with **International Accounting Standard 34**, 'Interim Financial Reporting,' and should be read in conjunction with the annual consolidated financial statements prepared under **IFRS**[26](index=26&type=chunk) - The adoption of amendments to **IAS 21**, 'Lack of Exchangeability,' on January 1, 2025, did not have any material impact on the Company's financial statements[29](index=29&type=chunk)[30](index=30&type=chunk) - No other new **IFRS** or **IFRIC** interpretations effective during the six months ended June 30, 2025, had a material impact, and future standards are not expected to have a significant impact[30](index=30&type=chunk)[31](index=31&type=chunk) [Note 4. Significant Accounting Judgements, Estimates, and Assumptions](index=8&type=section&id=Note%204.%20Significant%20Accounting%20Judgements%2C%20Estimates%2C%20and%20Assumptions) The preparation of financial statements requires management to make significant judgments, estimates, and assumptions; key areas involving significant accounting estimates include the going concern assessment, liability-classified warrants, and share-based compensation; these interim statements should be read with the annual consolidated financial statements for full disclosure on critical accounting judgments and estimation uncertainties - Significant accounting estimates are made in areas such as **going concern**, **liability-classified warrants**, and **share-based compensation**[35](index=35&type=chunk) - The unaudited condensed consolidated interim financial statements do not include all disclosures for critical accounting judgments and estimation uncertainties required in the annual consolidated financial statements[34](index=34&type=chunk) [Note 5. Revenue](index=9&type=section&id=Note%205.%20Revenue) Evaxion Biotech A/S recognized nominal revenue from its collaborative research agreement with MSD and a grant from the Gates Foundation during the three and six months ended June 30, 2025; the Gates Foundation awarded a $0.1 million grant in June 2025 to explore new polio vaccine designs using Evaxion's AI-Immunology™ platform, with the remainder of the revenue expected to be recognized through August 2025 Revenue Recognition (USD in millions) | Revenue Source | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :------------------------- | :------------------------------- | :----------------------------- | | MSD collaborative agreement | Nominal | $0.1 | | Gates Foundation Grant | Nominal | Nominal | - In June 2025, the Gates Foundation awarded the Company a **$0.1 million** grant for designing a new polio vaccine, leveraging Evaxion's AI-Immunology™ platform[38](index=38&type=chunk) [Note 6. Financial Instruments and Risk Management](index=9&type=section&id=Note%206.%20Financial%20Instruments%20and%20Risk%20Management) Evaxion manages liquidity, market (foreign exchange), and credit risks; the Company has sufficient funds into mid-2026, primarily faces foreign currency risk from USD operating expenses, and has limited credit risk due to high-credit-rating bank deposits; capital is managed through equity issuance, grants, licensing, or borrowings; the Company's 2025 Investor Warrants were initially classified as derivative liabilities but were partially reclassified to equity after an amendment in May 2025 - The Company has sufficient funds available to finance operations into **mid-2026**, mitigating liquidity risk[41](index=41&type=chunk) - Primary market risk is **foreign currency risk**, mainly from **USD-denominated operating expenses**, managed by converting financing proceeds to match expected cash outflows[42](index=42&type=chunk)[43](index=43&type=chunk) - Credit risk is limited to deposits with banks with **high credit ratings**, and no material credit risk is recognized[44](index=44&type=chunk) Financial Liabilities Measured at Fair Value (June 30, 2025) | Liability | Level 3 (USD in thousands) | | :-------------------- | :------------------------- | | 2025 Investor Warrants | $1,131 | Financial Liabilities Measured at Amortized Cost (June 30, 2025) | Liability | Level 3 (USD in thousands) | | :--------------- | :------------------------- | | EIB Loan | $8,866 | | Loan from lessor | $826 | - The **2025 Investor Warrants** were initially classified as derivative financial instruments due to foreign currency exercise price but were partially reclassified to equity after an amendment in May 2025[51](index=51&type=chunk)[52](index=52&type=chunk) [Note 7. Borrowings](index=12&type=section&id=Note%207.%20Borrowings) Evaxion's borrowings primarily consist of a loan from a lessor for laboratory facilities and an EIB Loan; the loan from the lessor, totaling $1.3 million, finances lab and office rebuilding at a 6% fixed interest rate over 8 years; the EIB Loan, received in February 2022 for €7.0 million (approximately $7.8 million), carries a 3% fixed interest rate and a 4% payment-in-kind interest rate, repayable in full six years after drawdown - The Company obtained **$1.3 million** in financing from DTU Science Park A/S for rebuilding laboratory and office facilities, repayable at a fixed interest rate of **6%** over **8 years**[57](index=57&type=chunk) - The **EIB Loan**, totaling **€7.0 million** (approximately **$7.8 million**), was received in February 2022, with a **3%** fixed interest rate and a **4%** payment-in-kind interest rate, repayable in full six years after drawdown[59](index=59&type=chunk) Summary of Borrowings (USD in thousands) | Borrowing Type | June 30, 2025 | December 31, 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](index=13&type=section&id=Note%208.%20Share-Based%20Payments) Evaxion operates a warrant program for employees, consultants, and board members, with warrants vesting over various periods and expiring between 2031 and 2036; as of June 30, 2025, warrants represented 4.3% of outstanding ordinary shares; the Company recognized $0.1 million in share-based compensation service cost for the six months ended June 30, 2025; fair value determination involves significant judgment regarding expected life and volatility, with volatility based on peer group data - The Company grants equity-settled warrants to employees, consultants, and board members, with vesting periods and expiration dates ranging from **2031** to **2036**[62](index=62&type=chunk) - As of June 30, 2025, the number of warrants as a percentage of outstanding ordinary shares was **4.3%**, up from **1.4%** at June 30, 2024[62](index=62&type=chunk) Warrants Granted and Exercisable | Metric | June 30, 2025 | June 30, 2024 | | :----------------------------------- | :------------ | :------------ | | Warrants granted as at December 31 | 3,044,794 | 2,738,473 | | Warrants granted during period | 1,372,407 | 538,460 | | Warrants forfeited | (83,662) | (84,559) | | **Warrants granted as at June 30** | **4,333,539** | **3,192,374** | | Warrants exercisable as at June 30 | 2,953,561 | 2,258,206 | Assumptions for Warrants Issued | Assumption | Six Months Ended June 30, 2025 | Six Months Ended June 30, 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](index=15&type=section&id=Note%209.%20Financial%20Income%20and%20Expenses) For the six months ended June 30, 2025, Evaxion reported net financial income of $1.410 million, a decrease from $3.556 million in the prior year period; this change was primarily driven by a significant reduction in the change in fair value of derivative liability, which decreased from $5.368 million in 2024 to $2.722 million in 2025 Financial Income and Expenses (USD in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :-------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | **Financial income:** | | | | | | Interest income, bank | $30 | $41 | $59 | $95 | | Foreign exchange gains | $208 | $131 | $208 | $203 | | 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) | | Foreign exchange losses | $(337) | $(123) | $(439) | $(139) | | Change in fair value of derivative liability | $(654) | $(1,654) | $(724) | $(1,654) | | **Total financial expenses** | **$(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](index=15&type=section&id=Note%2010.%20Capital%20Structure%20and%20Financial%20Matters) Evaxion's share capital underwent significant changes in early 2025, including a capital reduction on January 17, 2025, decreasing the nominal value per share from DKK 1 to DKK 0.25; this was followed by a public offering on January 31, 2025, generating $10.8 million in gross proceeds from the sale of ADSs and warrants, and additional sales through the JonesTrading Sales Agreement on January 24, 2025, yielding approximately $5.0 million Changes in Share Capital (Six Months Ended June 30, 2025) | Event | 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** | - On January 17, 2025, the Company completed a capital reduction, decreasing the nominal value of capital per share from **DKK 1** to **DKK 0.25**[70](index=70&type=chunk) - The January 2025 public offering generated gross proceeds of **$10.8 million** from the sale of **3,997,361 ADSs** and accompanying warrants[71](index=71&type=chunk) - Sales through the JonesTrading Sales Agreement on January 24, 2025, yielded approximately **$5.0 million** from **34,820,000 ordinary shares** represented by ADSs, concluding sales under this agreement[72](index=72&type=chunk) [Note 11. Commitments and Contingencies](index=16&type=section&id=Note%2011.%20Commitments%20and%20Contingencies) Evaxion may be involved in legal proceedings and claims in the ordinary course of business; however, the Company believes that any adverse outcome of existing claims would not have a material effect on its unaudited condensed consolidated interim financial statements - The Company does not anticipate any material effect on its financial statements from potential legal proceedings or claims[73](index=73&type=chunk) [Note 12. Events After the Reporting Period](index=17&type=section&id=Note%2012.%20Events%20After%20the%20Reporting%20Period) On July 11, 2025, Evaxion finalized a debt settlement agreement with the European Investment Bank (EIB), converting €3.5 million of its €7 million loan into equity via a purchase of ordinary Evaxion warrants at a premium; this agreement immediately increases Evaxion's equity by $4.1 million (€3.5 million), reduces overall liabilities, simplifies the balance sheet, and improves financial flexibility and cash flow - On July 11, 2025, Evaxion finalized a debt settlement agreement with the **EIB**, converting **€3.5 million** of its **€7 million** loan into equity[75](index=75&type=chunk) - The conversion involves EIB purchasing ordinary Evaxion warrants at a price of **$4.87**, representing an **89% premium** to the share price on July 11, 2025[75](index=75&type=chunk) - This agreement immediately increases Evaxion's equity by **$4.1 million** (**€3.5 million**), bolstering its capital structure, reducing liabilities, and improving financial flexibility and cash flow[75](index=75&type=chunk)
Evaxion announces business update and second quarter 2025 financial results
Globenewswire· 2025-08-14 11:30
Core Insights - Evaxion A/S is progressing well with its AI-Immunology™ powered vaccine development, maintaining operational momentum and aiming to achieve 2025 milestones [2][5][11] Business Highlights - The company is on track to present two-year clinical data for its personalized cancer vaccine EVX-01 at the ESMO Congress on October 17, 2025, which is expected to attract potential partners [6][7] - Evaxion has received a grant from the Gates Foundation to explore a new sub-unit vaccine against polio, highlighting external interest in its AI-Immunology™ platform [9][10] - The R&D pipeline has been expanded with the addition of EVX-B4, targeting Group A Streptococcus, showcasing the platform's scalability [10] Financial Update - As of June 30, 2025, cash and cash equivalents increased to $14.7 million from $6.0 million at the end of 2024, providing a cash runway until mid-2026 [16] - Revenue for the second quarter of 2025 was $37 thousand, a decrease from $154 thousand in the same period last year, primarily due to changes in collaborative agreements [17] - The net loss for the second quarter of 2025 was $4.8 million, an improvement from a net loss of $6.2 million in the same period of 2024 [21] R&D and Clinical Trials - The phase 2 trial for EVX-01 has completed patient treatment, with three-year data expected in 2026 following a one-year trial extension [8][7] - The company is actively engaged in preclinical activities and has received recognition for its AI-Immunology™ platform, which is applicable to over 100 diseases [9][10] Business Development - Ongoing discussions with MSD regarding the EVX-B2 and EVX-B3 programs may lead to option exercises in the latter half of 2025, with potential milestone payments for Evaxion [11][12] - The company aims to secure at least two new partnership deals in 2025, despite challenges posed by current financial market conditions [13] Capital Structure - An agreement with the European Investment Bank (EIB) converted €3.5 million of debt into equity, improving equity by $4.1 million and enhancing financial flexibility [14][15]
Evaxion to announce business update and second quarter 2025 financial results on August 14, 2025
Globenewswire· 2025-08-11 12:00
Company Overview - Evaxion A/S is a clinical-stage TechBio company that specializes in developing AI-Immunology™ powered vaccines [4] - The company utilizes proprietary AI prediction models to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [4] - Evaxion has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with high unmet medical needs [4] Upcoming Events - Evaxion will provide a business update and report its Q2 2025 financial results on August 14, 2025, before the opening of Nasdaq CM [1] - An executive management conference call and webcast will take place on the same day at 14:30 CET/08:30 EST, which is free and open to the public [2] - Participants can register in advance to receive dial-in numbers and a unique PIN code for the conference call [2] Contact Information - Mads Kronborg is the Vice President of Investor Relations & Communication at Evaxion, and can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]