Foreign Exchange Gains - For the years ended December 31, 2024, 2023, and 2022, the net foreign exchange gains were $0.3 million, $0.2 million, and $2.4 million, respectively[1101]. Interest Rate Risk - The company does not currently have any loans or holdings with variable interest rates, indicating no material exposure to interest rate risk[1102]. License Agreement and Payments - The company entered into a license agreement in June 2020, which triggered a milestone payment of $35,000, with potential future payments ranging from $70,000 to $250,000[1104]. Financial Instruments and Liabilities - The company issued warrants as part of a loan agreement with EIB, with the liability initially recognized at fair value and subsequently measured at amortized cost[1114][1115]. - The 2023 SPA Investor Warrants and 2024 Public Offering Investor Warrants were classified as derivative financial instruments due to their exercise price being in USD, not the company's functional currency[1116]. - The exercise price for the 2023 SPA Warrants was amended from $7.07 to DKK 47.99, and for the 2024 Investor Warrants from $4.00 to DKK 27.52, resulting in a change from liability to equity classification[1118]. Lease Agreement - The lease contract for premises customization has a repayment period of 8 years and an interest rate of 6% per annum[1120].

Financial Performance - Revenue for the full year 2024 was $3.3 million, a significant increase from $0.1 million in 2023, primarily due to a signed option and license agreement with MSD[25] - The net loss for 2024 was $10.6 million, or $(0.20) per share, compared to a net loss of $22.1 million, or $(0.81) per share in 2023[27] - Evaxion's total liabilities decreased to $14.1 million in 2024 from $17.6 million in 2023, reflecting improved financial health[29] - Cash and cash equivalents as of December 31, 2024, were $6.0 million, up from $5.6 million at the end of 2023, with expectations to fund operations until mid-2026[24] Expenses - Research and development expenses decreased to $10.5 million in 2024 from $11.9 million in 2023, attributed to reduced headcount and cost efficiencies[25] - General and administrative expenses were $7.6 million in 2024, down from $10.4 million in 2023, driven by management changes and cost reductions[26] - The company anticipates an operational cash burn of approximately $14 million in 2025, maintaining strict cost control[6] Clinical Trials and Development - The company completed dosing in the EVX-01 phase 2 trial in January 2025, with a one-year interim data showing a 69% overall response rate[11][12] - Evaxion expects to identify a lead vaccine candidate for its ERV-based precision cancer vaccine concept in the second half of 2025[13] - The partnership with MSD is progressing towards potential option exercise in the second half of 2025, with an option exercise fee of up to $10 million[8][9] Risks and Uncertainties - Key risks include financial condition, need for additional capital, and product development costs[34] - The company emphasizes dependence on third parties for clinical testing and product manufacturing[34] - There are uncertainties related to government regulation and protection of intellectual property rights[34] - The impact of international economic and geopolitical factors, including inflation, is highlighted as a risk[34] - The announcement includes forward-looking statements that may differ materially from actual results due to various risks[34] - The company does not assume any obligation to update forward-looking statements except as required by law[34]

Core Insights - Evaxion Biotech A/S has made significant advancements in business development, research, and financing, achieving key milestones in 2024 and early 2025 [2][3] - The company is focused on executing its business development strategy, continuing the EVX-01 phase 2 trial, and enhancing its AI-Immunology™ platform [5][6] - Financially, Evaxion reported a revenue increase to $3.3 million in 2024, compared to $0.1 million in 2023, primarily due to a licensing agreement with MSD [25] Business Highlights - Evaxion completed dosing in the EVX-01 phase 2 trial in January 2025, marking a significant milestone [3] - The company aims to launch an automated lead vaccine candidate design module and secure at least two new business agreements in 2025 [7][19] - A partnership with MSD on two vaccine candidates is progressing towards potential option exercise in the second half of 2025 [8][14] Research & Development Update - The EVX-01 trial is on track for a two-year clinical efficacy readout, with one-year data showing a 69% overall response rate [12][11] - Evaxion is advancing a novel precision cancer vaccine concept targeting ERV tumor antigens, with a lead candidate expected in the second half of 2025 [13] - The AI-Immunology™ platform has been enhanced to predict toxin antigens, improving the development of bacterial vaccines [17][18] Financial Overview - As of December 31, 2024, cash and cash equivalents were $6.0 million, up from $5.6 million in 2023, with a net loss of $10.6 million for the year [24][27] - Research and development expenses decreased to $10.5 million in 2024 from $11.9 million in 2023, reflecting cost efficiencies [25] - The company expects operational cash burn of approximately $14 million in 2025, maintaining cost control while increasing activity levels [6]

Company Overview - Evaxion Biotech 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 developed 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 full year 2024 financial results on April 1, 2025, before the opening of the Nasdaq CM [1] - The Executive Management will host a conference call and webcast on the same day at 14:30 CET/08:30 EST to present the update and results, as well as to take questions from the public [2] - The conference call is free and open to the public, with registration required to receive dial-in information [2] Contact Information - For inquiries, Mads Kronborg, Vice President of Investor Relations & Communication, can be contacted at +45 53 54 82 96 or via email at mak@evaxion.ai [4]

Core Insights - Evaxion Biotech A/S is set to present new data for its personalized cancer vaccine EVX-01 at the AACR Annual Meeting in April 2025, highlighting its ongoing commitment to advancing cancer treatment through AI-Immunology™ technology [1][2][3] Group 1: Clinical Trial and Data Presentation - The ongoing phase 2 trial of EVX-01 has produced strong interim one-year clinical data, with a two-year data readout expected in the second half of 2025 [4][8] - New biomarker and immune data from the trial will be presented, further enhancing the clinical data package for EVX-01 [2][8] - The trial investigates EVX-01 in combination with Merck's KEYTRUDA® (pembrolizumab) for advanced melanoma patients, with each vaccine tailored to individual patient biology [5][6] Group 2: Product Overview and Efficacy - EVX-01 is a personalized peptide-based cancer vaccine designed for first-line treatment of multiple advanced solid cancers, leveraging AI-Immunology™ to target unique tumor profiles [6][9] - Clinical trials have shown overall response rates of 69% and 67% in patients with advanced melanoma, indicating strong efficacy and predictive power of the AI platform [7]

Core Insights - Evaxion Biotech A/S is actively participating in various investor and scientific conferences in the US and Europe to provide updates and engage with stakeholders, which is a key part of its strategy to identify potential partnerships and collaborations [1][2] Conference Participation - Evaxion's upcoming conference schedule includes: - Immunotherapy and Immuno-Oncology Congress, March 12-14 in London - HC Wainwright AI Based Drug Discovery & Development Conference, April 2 (Virtual) - Jones Healthcare and Technology Innovation Conference, April 8-9 in Las Vegas - World Vaccine Congress, April 21-25 in Washington - AACR Annual Meeting, April 25-30 in Chicago - Sidoti Micro-Cap Conference, May 20-21 (Virtual) - Dark Genome Target Discovery & Development Summit, June 16-18 in Boston - BIO International Convention, June 16-19 in Boston - World Conference on Infectious Diseases, June 18-20 in Stockholm - International Neoantigen Summit, June 24-26 in Amsterdam - Additional conferences for stakeholder engagement where Evaxion will participate but not present [3] Company Overview - Evaxion is a pioneering TechBio company utilizing its AI platform, AI-Immunology™, to develop innovative immunotherapies for cancer, bacterial diseases, and viral infections. The company has a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with significant unmet medical needs [4]

Core Viewpoint - Evaxion Biotech A/S is extending its phase 2 trial of the personalized cancer vaccine EVX-01 from two to three years to enhance the data package and potentially document better treatment effects for advanced melanoma [1][4][9]. Group 1: Trial Details - The trial will allow active participants to enter a one-year extension after completing the initial two-year protocol, receiving additional doses of EVX-01 as monotherapy [2]. - The trial is progressing as planned, with a two-year data readout expected in the second half of 2025, and all active patients have shown a reduction in tumor target lesions [3][9]. - The extension aims to collect more data on clinical response duration and immune activation, which may provide insights into the durability of the immune response [9]. Group 2: Treatment Efficacy - Interim one-year data presented at the ESMO Congress in September 2024 showed a 69% overall response rate, with tumor target lesions reduced in 15 out of 16 patients [7]. - A positive correlation was observed between the AI-Immunology™ platform predictions and immune responses, with 79% of vaccine targets triggering a targeted immune response [7][10]. - In a completed phase 1/2a trial, 67% of metastatic melanoma patients had objective clinical responses, indicating the potential effectiveness of EVX-01 [9][10]. Group 3: Technology and Innovation - EVX-01 is developed using Evaxion's AI-Immunology™ platform, which tailors the vaccine to each patient's unique tumor profile and immune characteristics [5][8]. - The vaccine engages the patient's immune system to mount a targeted response against tumors, representing a novel approach in cancer treatment [5][8].

Core Points - Evaxion Biotech A/S has re-established compliance with Nasdaq's minimum stockholders' equity requirement and will remain listed on the exchange [1][8] - The company has significantly strengthened its equity and cash position, focusing on executing its strategy and pursuing 2025 milestones [2][8] - Evaxion completed a public offering of $10.8 million and raised an additional $7.6 million through other capital market activities, totaling approximately $17 million in cash and equity [5][8] Compliance and Financial Position - On January 28, 2025, Evaxion was given until May 12, 2025, to demonstrate compliance with Nasdaq listing rule 5550(b)(1), which requires stockholders' equity of at least $2.5 million [3] - The company has successfully executed its plan to restore equity and has re-established compliance with Nasdaq [3][4] - Nasdaq has imposed a "Mandatory Panel Monitor" for one year, during which Evaxion must maintain compliance to avoid delisting [4] Future Prospects - Evaxion is in discussions with the European Investment Bank regarding the conversion of €3.5 million of its €7 million loan, which is expected to increase equity by $3.7 million upon completion [6] - The agreement with the EIB is anticipated to be finalized in the first quarter of 2025 [6][8] - The company's cash runway has been extended to mid-2026 due to recent capital market activities [5][8]

Core Viewpoint - Evaxion Biotech A/S has successfully closed a public offering of 3,997,361 American Depositary Shares (ADSs) and warrants, raising gross proceeds of $10.8 million to advance its clinical pipeline and support operational expenses [1][4]. Group 1: Offering Details - The public offering price was set at $2.71 per ADS, with one warrant for every two ADSs purchased [1]. - The warrants have an exercise price of $2.71 per ADS, are immediately exercisable, and will expire five years after issuance [3]. - The offering was facilitated by Lake Street Capital Markets and Jones as exclusive placement agents [4]. Group 2: Participation and Use of Proceeds - MSD Global Health Innovation Fund, along with other healthcare-focused investment funds and members of Evaxion's Board of Directors and Management, participated in the offering [2]. - The net proceeds from the offering will be utilized to advance the company's preclinical and clinical pipeline, as well as for ongoing operating expenses and working capital [4]. Group 3: Company Overview - Evaxion Biotech A/S is a clinical-stage TechBio company that leverages its AI-Immunology™ platform to develop innovative vaccines targeting cancer, bacterial diseases, and viral infections [8]. - The company is focused on creating personalized vaccines and addressing high unmet medical needs in infectious diseases [8].

Core Viewpoint - Evaxion Biotech A/S has announced a public offering of 3,997,361 American Depositary Shares (ADSs) and warrants, priced at $2.71 per ADS, to raise approximately $10.8 million for advancing its clinical pipeline and operational expenses [1][4]. Group 1: Offering Details - The public offering includes warrants to purchase up to 50% of the ADSs offered, with an exercise price of $2.71 per ADS, exercisable immediately and expiring five years after issuance [3]. - The offering is expected to close on or about January 31, 2025, pending customary closing conditions [3]. - Lake Street Capital Markets, LLC and Jones are acting as exclusive placement agents for the offering [4]. Group 2: Participation and Use of Proceeds - MSD Global Health Innovation Fund, along with healthcare-focused investment funds and members of Evaxion's Board of Directors and Management, are participating in the offering [2]. - The net proceeds from the offering will be used to advance the company's preclinical and clinical pipeline, as well as for ongoing operating expenses and working capital [4]. Group 3: Company Overview - Evaxion Biotech A/S is a clinical-stage TechBio company that utilizes its AI-Immunology™ platform to develop vaccines targeting cancer, bacterial diseases, and viral infections [8]. - The company aims to transform patient care by providing innovative and targeted treatment options through its proprietary AI prediction models [8].