Core Viewpoint - Evaxion A/S is expanding its AI-Immunology™ platform to include the discovery and development of treatments for autoimmune diseases, alongside its existing focus on cancers and infectious diseases, aiming to address high unmet medical needs and enhance partnership opportunities [1][7]. Group 1: Expansion of AI-Immunology™ Platform - The expansion will leverage the scalability of the AI-Immunology™ platform, increasing the range of diseases that can be targeted for new treatments [2]. - Autoimmune diseases are characterized by significant unmet medical needs, presenting substantial partnership potential throughout all stages of drug development [2][7]. Group 2: Strategic Milestones for 2026 - The company has outlined several milestones for 2026, including the introduction of the AI-Immunology™ application for autoimmune diseases in the second half of the year [5][6]. - Other milestones include additional biomarker and immunogenicity data for EVX-01, three-year phase 2 clinical efficacy data for EVX-01, regulatory filing for phase 1 trial of EVX-04, and design and preclinical validation of antigens for EVX-B4, all targeted for the second half of 2026 [6]. Group 3: Financial Outlook - The development of applications for autoimmune diseases is included in Evaxion's cash flow outlook and will not affect its cash runway, which extends into the second half of 2027 [4].

Core Insights - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines and will present its 2026 milestones at the Biotech Showcase conference in San Francisco from January 12-14, 2026 [1][2] - The company aims to engage with stakeholders and potential business partners during the conference week [2] Company Overview - Evaxion utilizes its proprietary AI platform, AI-Immunology™, to decode the human immune system and create novel immunotherapies for cancer, bacterial diseases, and viral infections [3] - The company has developed a clinical-stage oncology pipeline of personalized vaccines and a preclinical pipeline targeting infectious diseases with significant unmet medical needs [3] - Evaxion is dedicated to transforming patient care through innovative and targeted treatment options [3] Presentation Details - The presentation by CEO Helen Tayton-Martin is scheduled for January 13, 2026, at 2:00 PM PST/11:00 PM CET in the Yosemite C track [3] - Contact information for investor relations is provided for further inquiries [3]

Core Viewpoint - Merck & Co. Inc. will not exercise its option for Evaxion A/S's Gonorrhea vaccine candidate EVX-B2, allowing Evaxion to retain global rights and seek another licensing partner [1][2]. Group 1: Company Developments - Evaxion's Gonorrhea vaccine candidate EVX-B2 has shown protective effects against the bacteria in preclinical studies, yet no vaccine has been approved for Gonorrhea despite over 80 million infections annually [2]. - Evaxion's CEO, Helen Tayton-Martin, stated that the decision by Merck does not affect the company's cash runway, which extends to the second half of 2027 [2]. - Merck's option was specifically for the protein-based version of EVX-B2, while Evaxion is also developing an mRNA version in collaboration with Afrigen Biologics [3]. Group 2: Financial Aspects - Evaxion received a cash payment of $7.5 million from Merck and is eligible for future milestone payments of up to $592 million, along with royalties on net sales for the EVX-B3 vaccine [4]. - Merck will take full responsibility for the further development and associated costs of the EVX-B3 vaccine [4]. Group 3: Market Reaction - Following the news, Evaxion's stock (EVAX) experienced a decline of 14.61%, trading at $4.91 [5].

Core Viewpoint - Evaxion A/S has lost the option for its Gonorrhea vaccine candidate EVX-B2 from MSD, but retains global rights and will seek another licensing partner while remaining committed to the program [1][4][8] Group 1: Company Developments - MSD will not exercise its option for the EVX-B2 vaccine candidate, allowing Evaxion to pursue other licensing opportunities [1][8] - Earlier in the year, MSD exercised its option for another Evaxion vaccine candidate, EVX-B3, which could yield milestone payments up to $592 million and royalties on net sales [2] - Evaxion is also developing an mRNA version of EVX-B2 in collaboration with Afrigen Biologics [5] Group 2: Vaccine Candidate Insights - Gonorrhea affects over 80 million people globally each year, and no vaccine has been approved to date despite extensive research [3] - Preclinical studies indicate that EVX-B2 provides protection against Gonorrhea bacteria, showcasing the potential of Evaxion's AI-Immunology™ platform [3][4] - The company remains optimistic about EVX-B2's potential to be the first approved vaccine for Gonorrhea, addressing a significant unmet medical need [4][8] Group 3: Financial Outlook - The decision by MSD does not impact Evaxion's cash runway, which is projected to extend into the second half of 2027 [5][8]

Summary of Evaxion Biotech A/S Conference Call Company Overview - **Company**: Evaxion Biotech A/S (Ticker: EVAX) - **Industry**: Biotechnology, specifically focusing on AI-powered vaccine development - **Founded**: 17 years ago as an AI company aimed at decoding the human immune system [2][3] Core Business and Strategy - **AI Immunology Platform**: A clinically validated platform for target discovery in vaccine development, significantly faster and more cost-effective than traditional methods [3][5][6] - **Partnerships**: Multi-partner approach with a focus on outlicensing programs by phase two of development, with Merck as a key collaborator and investor holding a 15% stake [4][10] - **Pipeline**: Strong pipeline in both cancer vaccines (e.g., EVX-01 for melanoma) and infectious disease vaccines (e.g., EVX-B2 for gonorrhea) [16][21] Financial Highlights - **Recent Deal**: Historic outlicensing deal with Merck for the EVX-B3 program, providing an immediate cash inflow of $7.5 million and potential milestone payments of up to $592 million [10][11] - **Cash Runway**: Extended cash runway until the second half of 2027, supported by various financial strategies including public offerings and agreements with the European Investment Bank [13][22] Market Potential - **Market Size**: The global market for cancer immunology and infectious disease vaccines is projected to grow significantly, with the infectious disease vaccine market expected to reach $68 billion by 2031 [7][8] - **Unmet Needs**: Focus on diseases with no approved vaccines, such as Staph aureus, gonorrhea, and CMV virus, indicating strong potential for future growth [9] Key Achievements - **Clinical Trials**: EVX-01 showed a 75% overall response rate in a two-year phase two trial, significantly outperforming Merck's Keytruda [18][19] - **Innovative Development**: Introduction of an automated vaccine design module to enhance efficiency and quality in vaccine development [12] Leadership and Team - **New CEO**: Helen Tayton-Martin appointed as CEO, bringing extensive experience from previous roles in the biotech industry [9] - **Experienced Team**: Strong leadership with backgrounds in major pharmaceutical companies, enhancing the company's credibility and operational capability [9] Future Outlook - **Resource Allocation**: Focus on developing infectious disease vaccines to the clinic stage while maintaining a higher investment in oncology programs [26] - **Partnership Opportunities**: Open to collaborations with various pharmaceutical companies, including potential expansions with Merck [27] Investor Insights - **Stock Performance**: The stock has increased by 110% over the last six months, driven by successful milestones and partnerships [29] - **Recognition**: Collaboration with the Gates Foundation for target discovery, highlighting the company's growing reputation in the industry [30] Conclusion - **Investment Case**: Evaxion presents a compelling investment opportunity with its pioneering AI platform, strong pipeline, and strategic partnerships, aiming for continued growth and value creation in the biotech sector [24][30]

Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's engagement with the scientific community and potential business partners [2] - The AI-Immunology™ platform has been instrumental in identifying novel ERV tumor antigens, which are targeted by EVX-04, showcasing the platform's unique capabilities in cancer vaccine development [3][4][11] Company Overview - Evaxion A/S is a clinical-stage TechBio company focused on developing AI-Immunology™ powered vaccines, with a commitment to transforming patient care through innovative immunotherapies [12] - The company’s proprietary AI platform enables the identification of therapeutically relevant tumor antigens, which are crucial for the development of effective cancer vaccines [11][12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine specifically for acute myeloid leukemia (AML), addressing a significant unmet medical need due to the high mortality rates associated with the disease [10] - The vaccine targets non-conventional ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal candidates for cancer immunotherapy [4][10] AML Context - Acute myeloid leukemia (AML) is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, leading to a low overall survival rate of 25% over three years for those receiving standard low-intensity chemotherapy [9]

Core Insights - Evaxion A/S has announced promising new data for its AML vaccine candidate, EVX-04, which shows strong T-cell responses and effective tumor growth prevention in preclinical models [1][5][10] - The data was presented at the American Society of Hematology Annual Meeting, highlighting the company's commitment to engaging with the scientific community and potential partners [2] - The AI-Immunology™ platform has enabled the identification of unique ERV tumor antigens, which are selectively expressed in tumors but absent in normal tissues, making them ideal targets for cancer vaccines [4][11] Company Overview - Evaxion is a clinical-stage TechBio company focused on developing AI-powered vaccines, particularly in the field of immunology [1][12] - The company utilizes its proprietary AI-Immunology™ platform to decode the human immune system and create novel immunotherapies for various diseases, including cancer [12] Product Details - EVX-04 is designed as an off-the-shelf therapeutic cancer vaccine for acute myeloid leukemia (AML), addressing a significant unmet medical need due to high mortality rates associated with the disease [10] - The vaccine targets multiple non-conventional ERV tumor antigens, which have been shown to elicit specific immune responses and prevent tumor growth in preclinical models [5][10] - The data-driven approach ensures broad tumor coverage, making EVX-04 applicable across various cancers where current immunotherapies are inadequate [6][10] Market Context - AML is characterized by high mortality rates and limited treatment options, with a median age of diagnosis at 68 years and a long-term survival rate of only 40% for younger patients undergoing intensive treatment [8][9] - Approximately 50% of AML patients are not fit for intensive treatment, relying on low-intensity chemotherapy, which has a poor three-year overall survival rate of only 25% [9]

Core Insights - Several biotechnology and pharmaceutical companies experienced significant gains in after-hours trading due to corporate updates and upcoming event announcements [1] Company Updates - Jasper Therapeutics, Inc. (JSPR) saw a 21.51% increase to $2.09 after hours, following the announcement of a webinar on December 2 to present findings from the BEACON study and preliminary data from the ETESIAN study [2] - NRx Pharmaceuticals, Inc. (NRXP) rose 13.39% to $2.71 after hours, with the CEO scheduled to present at NobleCon21 on December 3, discussing the company's expanded focus and clinical revenue progress [3] - Unicycive Therapeutics, Inc. (UNCY) increased by 5.42% to $6.33, with the CEO participating in two upcoming events, although no new announcements were made on Monday [4] - Spruce Biosciences, Inc. (SPRB) shares rose 4.68% to $87.00 after reporting a net loss of $8.2 million for the quarter ending September 30, 2025, an improvement from a net loss of $8.7 million in the previous year [5] - Evaxion A/S (EVAX) added 3.96% to $5.65, announcing progress in its CMV vaccine program with new protective data and ongoing preclinical development [6] - Solana Company (HSDT) gained 3.48% to $3.87, reporting a net loss of $352.8 million for the third quarter, a significant increase from a net loss of $3.7 million in the prior-year period, with revenue totaling $697,000 [7] - Protara Therapeutics, Inc. (TARA) rose 5.04% to $7.08, planning a conference call on December 3 to review interim data from its Phase 2 trial of TARA-002 in bladder cancer patients [8]

TABLE OF CONTENTS As filed with the Securities and Exchange Commission on November 21, 2025 Registration Statement No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT Dr. Neergaards Vej 5F 2970 Hørsholm Denmark Telephone: +45 31 31 97 53 (Address, including zip code, and telephone number, including area code, of registrant's principal executive offices) Birgitte Rønø Interim Chief Executive Officer Evaxion A/S Dr. Neergaards Vej 5F 2970 Hørsholm D ...

Core Insights - Evaxion A/S is advancing its multi-component cytomegalovirus (CMV) vaccine program, EVX-V1, demonstrating protective effects of lead antigens [1][3] - The company utilizes its AI-Immunology™ platform to discover novel CMV antigens that induce specific immune responses and inhibit viral infection [2][4] - The CMV treatment market was valued at $474.6 million in 2023 and is expected to grow at a CAGR of 6.6% from 2024 to 2032, driven by increased awareness and prevalence of CMV infections [7] Company Overview - Evaxion is a clinical-stage TechBio company focused on developing AI-powered vaccines, particularly for CMV and other infectious diseases [1][10] - The company’s proprietary AI-optimized pre-fusion glycoprotein B (gB) antigen shows superior performance in neutralizing CMV compared to traditional antigens [3][9] - Evaxion is actively seeking strategic partnerships to accelerate the development of its vaccine programs [5] Industry Context - CMV infects approximately 60% to 70% of adults in developed countries and nearly 100% in developing economies, highlighting a significant medical need for effective treatments [6][8] - Despite extensive research over decades, no CMV vaccine has been approved to date, underscoring the importance of Evaxion's discoveries [9][10]